ID

37159

Beschrijving

Study ID: 104864/502 Clinical Study ID: 104864/502 Study Title: An Open-Label, Multicenter, Randomized, Phase II Study of Oral Topotecan Daily x 5 Days vs. Oral Topotecan 5 Days On, 2 Days Off for 3 Weeks for Second-Line Treatment in Patients with Recurrent, Locally Advanced or Metastatic Cervical Cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: N/A Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Topotecan Trade Name: N/A Study Indication: Cancer, Locally Advanced or Metastatic Cervical Cancer

Trefwoorden

Versies (1)
  1. 05-07-19 05-07-19 -
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GlaxoSmithKline

Geüploaded op

5 juli 2019

DOI

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Licentie

Creative Commons BY-NC 3.0
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Oral Topotecan Daily x 5 Days vs. Oral Topotacan 5 Days On, 2 Days Off; 104864/502

Engels

Screening

1 Formulieren  
  1. StudyEvent: ODM
    1. Screening
Administrative Data
Beschrijving

Administrative Data

Alias
UMLS CUI-1
C1320722
Center Number
Beschrijving

Institution name, Identifier

Datatype

integer

Alias
UMLS CUI [1,1]
C1301943
UMLS CUI [1,2]
C0600091
Patient Number
Beschrijving

Patient number

Datatype

integer

Alias
UMLS CUI [1]
C1830427
Patient Initials
Beschrijving

Person Initials

Datatype

text

Alias
UMLS CUI [1]
C2986440
Visit Date
Beschrijving

Date of visit

Datatype

date

Alias
UMLS CUI [1]
C1320303
Demography
Beschrijving

Demography

Alias
UMLS CUI-1
C0011298
Date of Birth
Beschrijving

Patient date of birth

Datatype

date

Alias
UMLS CUI [1]
C0421451
Gender
Beschrijving

Gender

Datatype

text

Alias
UMLS CUI [1]
C0079399
Race
Beschrijving

Racial group

Datatype

text

Alias
UMLS CUI [1]
C0034510
Race, specify
Beschrijving

Racial group

Datatype

text

Alias
UMLS CUI [1]
C0034510
Vital Signs
Beschrijving

Vital Signs

Alias
UMLS CUI-1
C0518766
Temperature
Beschrijving

Body temperature measurement, Route

Datatype

text

Alias
UMLS CUI [1,1]
C0886414
UMLS CUI [1,2]
C0449444
Temperature
Beschrijving

Body Temperature, Unit of Measure

Datatype

text

Alias
UMLS CUI [1,1]
C0005903
UMLS CUI [1,2]
C1519795
Temperature
Beschrijving

Body Temperature

Datatype

float

Alias
UMLS CUI [1]
C0005903
After 5 Minutes Sitting - Sitting Blood Pressure - Systolic
Beschrijving

Systolic Pressure, Sitting position

Datatype

integer

Maateenheden
  • mmHg
Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0277814
mmHg
After 5 Minutes Sitting - Sitting Blood Pressure - Diastolic
Beschrijving

Diastolic blood pressure, Sitting position

Datatype

integer

Maateenheden
  • mmHg
Alias
UMLS CUI [1,1]
C0428883
UMLS CUI [1,2]
C0277814
mmHg
After 5 Minutes Sitting - Pulse
Beschrijving

Heart rate while sitting

Datatype

integer

Maateenheden
  • bpm
Alias
UMLS CUI [1]
C2029904
bpm
History of Cervical Carcinoma
Beschrijving

History of Cervical Carcinoma

Alias
UMLS CUI-1
C0302592
UMLS CUI-2
C0262926
Record the date of diagnosis of primary disease
Beschrijving

Cervix carcinoma, Date of diagnosis

Datatype

date

Alias
UMLS CUI [1,1]
C0302592
UMLS CUI [1,2]
C2316983
Record the date of the last recurrence or mark the N/A box if no remission obtained.
Beschrijving

Cervix carcinoma, End Date

Datatype

date

Alias
UMLS CUI [1,1]
C0302592
UMLS CUI [1,2]
C0806020
Record the date of the last recurrence or mark the N/A box if no remission obtained.
Beschrijving

Cervix carcinoma, End Date

Datatype

text

Alias
UMLS CUI [1,1]
C0302592
UMLS CUI [1,2]
C0806020
Previous Surgical Procedures for Cervical Carcinoma
Beschrijving

Previous Surgical Procedures for Cervical Carcinoma

Alias
UMLS CUI-1
C0302592
UMLS CUI-2
C0543467
UMLS CUI-3
C0205156
Has the patient had any surgical procedure(s) as therapy for cervical carcinoma?
Beschrijving

Cervix carcinoma, Operative Surgical Procedures, Previous

Datatype

boolean

Alias
UMLS CUI [1,1]
C0302592
UMLS CUI [1,2]
C0543467
UMLS CUI [1,3]
C0205156
Surgical Procedure
Beschrijving

Cervix carcinoma, Operative Surgical Procedures

Datatype

text

Alias
UMLS CUI [1,1]
C0302592
UMLS CUI [1,2]
C0543467
Date
Beschrijving

Cervix carcinoma, Operative Surgical Procedures, Date in time

Datatype

date

Alias
UMLS CUI [1,1]
C0302592
UMLS CUI [1,2]
C0543467
UMLS CUI [1,3]
C0011008
Previous Chemotherapy for Cervical Carcinoma
Beschrijving

Previous Chemotherapy for Cervical Carcinoma

Alias
UMLS CUI-1
C0392920
UMLS CUI-2
C0205156
UMLS CUI-3
C0205156
Has the patient had any chemotherapy as therapy for cervical carcinoma?
Beschrijving

Cervix carcinoma, Chemotherapy Regimen, Previous

Datatype

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0205156
UMLS CUI [1,3]
C0205156
Regimen
Beschrijving

Cervix carcinoma, Chemotherapy Regimen

Datatype

text

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0205156
Cumulative Dose
Beschrijving

Cervix carcinoma, Chemotherapy Regimen, Cumulative Dose

Datatype

text

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0205156
UMLS CUI [1,3]
C2986497
Start Date
Beschrijving

Cervix carcinoma, Chemotherapy Regimen, Start Date

Datatype

date

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0205156
UMLS CUI [1,3]
C0808070
End Date
Beschrijving

Cervix carcinoma, Chemotherapy Regimen, End Date

Datatype

date

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0205156
UMLS CUI [1,3]
C0806020
Best Overall Response Code
Beschrijving

Cervix carcinoma, Chemotherapy Regimen, Best Overall Response

Datatype

text

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0205156
UMLS CUI [1,3]
C2986560
If complete or partial response, duration of response (Weeks)
Beschrijving

Cervix carcinoma, Chemotherapy Regimen, Response Duration

Datatype

integer

Maateenheden
  • weeks
Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0392920
UMLS CUI [1,3]
C0237585
weeks
Radiation Sensitizer
Beschrijving

Cervix carcinoma, Chemotherapy Regimen, Radiation Sensitizing Agents

Datatype

text

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0392920
UMLS CUI [1,3]
C0034541
Previous Biological Therapy or Immunotherapy for Cervical Carcinoma
Beschrijving

Previous Biological Therapy or Immunotherapy for Cervical Carcinoma

Alias
UMLS CUI-1
C0302592
UMLS CUI-2
C1531518
UMLS CUI-4
C0302592
UMLS CUI-5
C0021083
Has the patient had any biological therapy or immunotherapy for cervical carcinoma?
Beschrijving

Cervix carnoma, Biological Therapy; Cervix carcinoma, Immunotherapy

Datatype

boolean

Alias
UMLS CUI [1,1]
C0302592
UMLS CUI [1,2]
C1531518
UMLS CUI [2,1]
C0302592
UMLS CUI [2,2]
C0021083
Regimen
Beschrijving

Cervix carnoma, Biological Therapy, Therapeutic regimen; Cervix carcinoma, Immunotherapy, Therapeutic regimen

Datatype

text

Alias
UMLS CUI [1,1]
C0302592
UMLS CUI [1,2]
C1531518
UMLS CUI [1,3]
C1276413
UMLS CUI [2,1]
C0302592
UMLS CUI [2,2]
C0021083
UMLS CUI [2,3]
C1276413
Therapy
Beschrijving

Cervix carnoma, Biological Therapy, Therapeutic procedure; Cervix carcinoma, Immunotherapy, Therapeutic procedure

Datatype

text

Alias
UMLS CUI [1,1]
C0302592
UMLS CUI [1,2]
C1531518
UMLS CUI [1,3]
C0087111
UMLS CUI [2,1]
C0302592
UMLS CUI [2,2]
C0021083
UMLS CUI [2,3]
C0087111
Cumulative Dose
Beschrijving

Cervix carnoma, Biological Therapy, Cumulative Dose; Cervix carcinoma, Immunotherapy, Cumulative Dose

Datatype

text

Alias
UMLS CUI [1,1]
C0302592
UMLS CUI [1,2]
C1531518
UMLS CUI [1,3]
C2986497
UMLS CUI [2,1]
C0302592
UMLS CUI [2,2]
C0021083
UMLS CUI [2,3]
C2986497
Start Date
Beschrijving

Cervix carnoma, Biological Therapy, Start Date; Cervix carcinoma, Immunotherapy, Start Date

Datatype

date

Alias
UMLS CUI [1,1]
C0302592
UMLS CUI [1,2]
C1531518
UMLS CUI [1,3]
C0808070
UMLS CUI [2,1]
C0302592
UMLS CUI [2,2]
C0021083
UMLS CUI [2,3]
C0808070
End Date
Beschrijving

Cervix carnoma, Biological Therapy, End Date; Cervix carcinoma, Immunotherapy, End Date

Datatype

date

Alias
UMLS CUI [1,1]
C0302592
UMLS CUI [1,2]
C1531518
UMLS CUI [1,3]
C0806020
UMLS CUI [2,1]
C0302592
UMLS CUI [2,2]
C0021083
UMLS CUI [2,3]
C0806020
Best Overall Response Code
Beschrijving

Cervix carnoma, Biological Therapy, Best Overall Response; Cervix carcinoma, Immunotherapy, Best Overall Response

Datatype

text

Alias
UMLS CUI [1,1]
C0302592
UMLS CUI [1,2]
C1531518
UMLS CUI [1,3]
C2986560
UMLS CUI [2,1]
C0302592
UMLS CUI [2,2]
C0021083
UMLS CUI [2,3]
C2986560
If complete or partial response, duration of response (Weeks)
Beschrijving

Cervix carnoma, Biological Therapy, Response Duration; Cervix carcinoma, Immunotherapy, Response Duration

Datatype

integer

Maateenheden
  • weeks
Alias
UMLS CUI [1,1]
C0302592
UMLS CUI [1,2]
C1531518
UMLS CUI [1,3]
C0237585
UMLS CUI [2,1]
C0302592
UMLS CUI [2,2]
C0021083
UMLS CUI [2,3]
C0237585
weeks
Previous Radiotherapy for Cervical Carcinoma
Beschrijving

Previous Radiotherapy for Cervical Carcinoma

Alias
UMLS CUI-1
C0302592
UMLS CUI-2
C1522449
Has the patient had any radiotherapy as therapy for cervical carcinoma?
Beschrijving

Cervix carcinoma, Therapeutic radiology procedure

Datatype

boolean

Alias
UMLS CUI [1,1]
C0302592
UMLS CUI [1,2]
C1522449
Field Site
Beschrijving

Cervix carcinoma, Therapeutic radiology procedure, Radiation Field

Datatype

text

Alias
UMLS CUI [1,1]
C0302592
UMLS CUI [1,2]
C1522449
UMLS CUI [1,3]
C1882536
Start Date
Beschrijving

Cervix carcinoma, Therapeutic radiology procedure, Start Date

Datatype

date

Alias
UMLS CUI [1,1]
C0302592
UMLS CUI [1,2]
C1522449
UMLS CUI [1,3]
C0808070
End Date
Beschrijving

Cervix carcinoma, Therapeutic radiology procedure, End Date

Datatype

date

Alias
UMLS CUI [1,1]
C0302592
UMLS CUI [1,2]
C1522449
UMLS CUI [1,3]
C0806020
Best Overall Response Code
Beschrijving

Cervix carcinoma, Therapeutic radiology procedure, Best Overall Response

Datatype

text

Alias
UMLS CUI [1,1]
C0302592
UMLS CUI [1,2]
C1522449
UMLS CUI [1,3]
C2986560
Toxicities Related to Previous Therapy for Cervical Carcinoma
Beschrijving

Toxicities Related to Previous Therapy for Cervical Carcinoma

Alias
UMLS CUI-1
C0302592
UMLS CUI-2
C0087111
UMLS CUI-3
C0013221
Does the patient have any residual toxicities related to therapy for cervical carcinoma?
Beschrijving

Cervix carcinoma, Therapeutic procedures, Drug toxicity

Datatype

boolean

Alias
UMLS CUI [1,1]
C0302592
UMLS CUI [1,2]
C0087111
UMLS CUI [1,3]
C0013221
Toxicity
Beschrijving

Cervix carcinoma, Therapeutic procedures, Drug toxicity

Datatype

text

Alias
UMLS CUI [1,1]
C0302592
UMLS CUI [1,2]
C0087111
UMLS CUI [1,3]
C0013221
NCI Grade
Beschrijving

Cervix carcinoma, Therapeutic procedures, Drug toxicity, Toxicity Grade

Datatype

text

Alias
UMLS CUI [1,1]
C0302592
UMLS CUI [1,2]
C0087111
UMLS CUI [1,3]
C0013221
UMLS CUI [1,4]
C2826262
Previous Therapy
Beschrijving

Cervix carcinoma, Therapeutic procedures, Drug toxicity

Datatype

text

Alias
UMLS CUI [1,1]
C0302592
UMLS CUI [1,2]
C0087111
UMLS CUI [1,3]
C0013221
UMLS CUI [1,4]
C2826262
12-Lead Electrocardiogram
Beschrijving

12-Lead Electrocardiogram

Alias
UMLS CUI-1
C0430456
Date Performed
Beschrijving

12 lead ECG, Date in time

Datatype

date

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0011008
Finding
Beschrijving

12 lead ECG, Result

Datatype

text

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C1274040
Diagnostic Studies for Tumor Assessment
Beschrijving

Diagnostic Studies for Tumor Assessment

Alias
UMLS CUI-1
C0302592
UMLS CUI-2
C3889740
Diagnostic Procedure
Beschrijving

Cervix carcinoma, Tumor Results Assessment Test, Diagnostic Procedure

Datatype

text

Alias
UMLS CUI [1,1]
C0430022
UMLS CUI [1,2]
C1274040
UMLS CUI [1,3]
C0430022
Date Performed
Beschrijving

Cervix carcinoma, Tumor Results Assessment Test, Date in time

Datatype

date

Alias
UMLS CUI [1,1]
C0430022
UMLS CUI [1,2]
C1274040
UMLS CUI [1,3]
C0011008
Result
Beschrijving

Cervix carcinoma, Tumor Results Assessment Test, Result

Datatype

text

Alias
UMLS CUI [1,1]
C0430022
UMLS CUI [1,2]
C1274040
UMLS CUI [1,3]
C1274040
Ongoing Medical Conditions associated with Cervical Carcinoma
Beschrijving

Ongoing Medical Conditions associated with Cervical Carcinoma

Alias
UMLS CUI-1
C0302592
UMLS CUI-2
C0348080
UMLS CUI-3
C0332281
Does the patient have any ongoing medical condition(s) that is associated or possibly associated with cervical carcinoma?
Beschrijving

Cervix carcinoma, Condition, Associated

Datatype

boolean

Alias
UMLS CUI [1,1]
C0302592
UMLS CUI [1,2]
C0348080
UMLS CUI [1,3]
C0332281
Condition
Beschrijving

Cervix carcinoma, Condition, Associated

Datatype

text

Alias
UMLS CUI [1,1]
C0302592
UMLS CUI [1,2]
C0348080
UMLS CUI [1,3]
C0332281
NCI Grade
Beschrijving

Cervix carcinoma, Condition, Associated, National Cancer Institute common terminology criteria for adverse event grade finding

Datatype

text

Alias
UMLS CUI [1,1]
C0302592
UMLS CUI [1,2]
C0348080
UMLS CUI [1,3]
C0332281
UMLS CUI [1,4]
C3887242
Year of first Diagnosis
Beschrijving

Cervix carcinoma, Condition, Associated, Start Date

Datatype

integer

Alias
UMLS CUI [1,1]
C0302592
UMLS CUI [1,2]
C0348080
UMLS CUI [1,3]
C0332281
UMLS CUI [1,4]
C0808070
Significant Medical/Surgical History and Physical Examination
Beschrijving

Significant Medical/Surgical History and Physical Examination

Alias
UMLS CUI-1
C0262926
UMLS CUI-2
C0489540
UMLS CUI-3
C0031809
Is the patient suffering from or has she ever suffered from any significant medical or surgical condition (other than cervical carcinoma or conditions related to therapy for cervical carcinoma - page 6)?
Beschrijving

Medical History; History of surgical procedures

Datatype

boolean

Alias
UMLS CUI [1]
C0262926
UMLS CUI [2]
C0489540
Diagnosis
Beschrijving

Medical History, Diagnosis; History of surgical procedures, Diagnosis; Physical Examination, Diagnosis

Datatype

text

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0011900
UMLS CUI [2,1]
C1948041
UMLS CUI [2,2]
C0011900
UMLS CUI [3,1]
C0031809
UMLS CUI [3,2]
C0011900
NCI Grade
Beschrijving

Medical History, Diagnosis, National Cancer Institute common terminology criteria for adverse event grade finding; History of surgical procedures, Diagnosis, National Cancer Institute common terminology criteria for adverse event grade finding; Physical Examination, Diagnosis, National Cancer Institute common terminology criteria for adverse event grade finding

Datatype

text

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0011900
UMLS CUI [1,3]
C3887242
UMLS CUI [2,1]
C1948041
UMLS CUI [2,2]
C0011900
UMLS CUI [2,3]
C3887242
UMLS CUI [3,1]
C0031809
UMLS CUI [3,2]
C0011900
UMLS CUI [3,3]
C3887242
Year of first Diagnosis
Beschrijving

Medical History, Diagnosis, Start Date; History of surgical procedures, Diagnosis, Start Date; Physical Examination, Diagnosis, Start Date

Datatype

date

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0011900
UMLS CUI [1,3]
C0808070
UMLS CUI [2,1]
C1948041
UMLS CUI [2,2]
C0011900
UMLS CUI [2,3]
C0808070
UMLS CUI [3,1]
C0031809
UMLS CUI [3,2]
C0011900
UMLS CUI [3,3]
C0808070
Past
Beschrijving

Medical History, Diagnosis, In the past; History of surgical procedures, Diagnosis, In the past; Physical Examination, Diagnosis, In the past

Datatype

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0011900
UMLS CUI [1,3]
C1444637
UMLS CUI [2,1]
C1948041
UMLS CUI [2,2]
C0011900
UMLS CUI [2,3]
C1444637
UMLS CUI [3,1]
C0031809
UMLS CUI [3,2]
C0011900
UMLS CUI [3,3]
C1444637
Current/ Active
Beschrijving

Medical History, Diagnosis, Current; History of surgical procedures, Diagnosis, Current; Physical Examination, Diagnosis, Current

Datatype

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0011900
UMLS CUI [1,3]
C0521116
UMLS CUI [2,1]
C1948041
UMLS CUI [2,2]
C0011900
UMLS CUI [2,3]
C0521116
UMLS CUI [3,1]
C0031809
UMLS CUI [3,2]
C0011900
UMLS CUI [3,3]
C0521116
Pior and Concomitant Medication
Beschrijving

Pior and Concomitant Medication

Alias
UMLS CUI-1
C2347852
UMLS CUI-2
C2826257
Has the patient taken any medication in the past 30 days? (Exclude previous chemotherapy, immunotherapy, biologic therapy or radiotherapy, which should be recorded on pages 3, 4, and 5.)
Beschrijving

Prior Medication Usage

Datatype

boolean

Alias
UMLS CUI [1]
C2826257
Drug Name (Trade Name Preferred)
Beschrijving

Prior Medication Usage, Medication name

Datatype

text

Alias
UMLS CUI [1,1]
C2826257
UMLS CUI [1,2]
C2360065
Unit Dose
Beschrijving

Prior Medication Usage, Unit of Measure, Medication Dose

Datatype

text

Alias
UMLS CUI [1,1]
C2826257
UMLS CUI [1,2]
C1519795
UMLS CUI [1,3]
C3174092
Frequency
Beschrijving

Prior Medication Usage, Frequencies

Datatype

text

Alias
UMLS CUI [1,1]
C2826257
UMLS CUI [1,2]
C0439603
Route
Beschrijving

Prior Medication Usage, Drug Administration Routes

Datatype

text

Alias
UMLS CUI [1,1]
C2826257
UMLS CUI [1,2]
C0013153
Medical Illness/ Diagnosis (or symptom in ab- sence of diagnosis)
Beschrijving

Prior Medication Usage, Disease

Datatype

text

Alias
UMLS CUI [1,1]
C2826257
UMLS CUI [1,2]
C0012634
Start Date
Beschrijving

Prior Medication Usage, Start Date

Datatype

date

Alias
UMLS CUI [1,1]
C2826257
UMLS CUI [1,2]
C0808070
End Date
Beschrijving

Prior Medication Usage, End Date

Datatype

date

Alias
UMLS CUI [1,1]
C2826257
UMLS CUI [1,2]
C0806020
If Continuing mark box
Beschrijving

Prior Medication Usage, Continuous

Datatype

date

Alias
UMLS CUI [1,1]
C2826257
UMLS CUI [1,2]
C0549178
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI-1
C1512693
Written informed consent.
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
At least 18 years of age.
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
Histologic documentation of squamous cell cervical cancer.
Beschrijving

Cervix carcinoma, Squamous cell carcinoma

Datatype

boolean

Alias
UMLS CUI [1,1]
C0302592
UMLS CUI [1,2]
C0007137
Patient with recurrent, locally advanced or metastatic cervical cancer.
Beschrijving

Cervix carcinoma recurrent; Cervix carcinoma, Advanced phase, Locally; Cervix carcinoma, Metastatic from

Datatype

boolean

Alias
UMLS CUI [1]
C0278579
UMLS CUI [2,1]
C0302592
UMLS CUI [2,2]
C0205179
UMLS CUI [2,3]
C1517927
UMLS CUI [3,1]
C0302592
UMLS CUI [3,2]
C0332295
Patient is eligible with respect to prior chemotherapy if she received one of the following: 1) Chemotherapy for first-line treatment 2) Chemotherapy for first-line treatment and chemotherapy as a radiosensitizer or 3) Chemotherapy as a radiosensitizer.
Beschrijving

Chemotherapy Regimen, Eligibility Determination

Datatype

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0013893
At least 4 weeks since prior pelvic radiation. The measurable lesion(s) may be in the field(s) of prior radiation if at least 6 weeks have elapsed since the last radiotherapy treatment and providing that the lesion is demonstrated, by CT scan, to be progressing.
Beschrijving

Radiotherapy to Pelvis, Previous

Datatype

boolean

Alias
UMLS CUI [1,1]
C1536155
UMLS CUI [1,2]
C0205156
Presence of at least one bidimensionally measurable, non-CNS lesion (indicator lesion) defined by diagnostic studies including CT or MRI scan. • Measurable disease on CT or MRI scan must have both diameters ≥ 1 cm. • Measurable disease on chest x-ray must have both diameters ≥ 2cm. • Palpable tumor masses that cannot be evaluated radiologically must have two diameters ≥ 1 cm.
Beschrijving

Lesion

Datatype

boolean

Alias
UMLS CUI [1]
C0221198
Patient is not considered to be a candidate for curvative surgery.
Beschrijving

Curative Surgery, Eligibility Determination

Datatype

boolean

Alias
UMLS CUI [1,1]
C1511562
UMLS CUI [1,2]
C0013893
Patient has completely recovered from recent surgery.
Beschrijving

Operative Surgical Procedures, Complete Recovery

Datatype

boolean

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C2826210
At least 4 weeks since last chemotherapy or biologic therapy. No concurrent biologic therapy or immunotherapy is allowed.
Beschrijving

Chemotherapy Regimen, Past; Biological treatment, Past

Datatype

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C1444637
UMLS CUI [2,1]
C1531518
UMLS CUI [2,2]
C1444637
Laboratory values as follows: • Hemoglobin ≥ 8.0 g/dL (after transfusion if needed) • WBC ≥ 3,500/mm3 • Neutrophils ≥ 1,500/mm3 • Platelets ≥ 100,000/mm3 • Creatinine ≤ 1.5 mg/dL (133 umol/L) or creatinine clearance ≥ 60 mL/min. If the creatinine clearance is between 40ml/min - 60ml/min, a 24 hour clearance is required. If the measurement remains between 40 ml/min - 60 ml/min, the patient should be dose reduced 1 dose level to start the study. • Serum bilirubin ≤ 2.0 mg/dL (≤ 35 umol/L) • SGOT/AST, SGPT/ALT, and alkaline phosphatase ≤ 2 times the upper limit of normal if liver metastases are absent by abdominal CT or MRI scan or ≤ 5 times the upper limit of normal if liver metastases are present.
Beschrijving

Laboratory Procedures, Finding

Datatype

boolean

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0243095
Performance status ≤ 2 (GOG Scale, protocol Appendix F) and life expectancy ≥ 3 months.
Beschrijving

ECOG performance status; Life expectancy

Datatype

boolean

Alias
UMLS CUI [1,1]
C1520224
UMLS CUI [1,2]
C0023671
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI-1
C0680251
Patient with uncontrolled emesis, regardless of etiology.
Beschrijving

Vomiting, Uncontrolled

Datatype

text

Alias
UMLS CUI [1,1]
C0042963
UMLS CUI [1,2]
C0205318
Any condition of the GI tract which would affect GI absorption or motility (e.g. autonomic neuropathy, active gastric or duodenal ulcers, certain gastrointestinal surgeries). Patients receiving cisapride to maintain motility or gastric emptying are also excluded.
Beschrijving

Gastrointestinal Diseases

Datatype

boolean

Alias
UMLS CUI [1]
C0017178
Histologic documentation of adenocarcinoma of the cervix.
Beschrijving

Cervix carcinoma, Adenocarcinoma

Datatype

boolean

Alias
UMLS CUI [1,1]
C0302592
UMLS CUI [1,2]
C0001418
Concomitant malignancies or previous malignancies within the last five years, with the exception of adequately treated basal or squamous cell carcinoma of the skin.
Beschrijving

Malignant Neoplasms, Previous

Datatype

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0205156
Active infection.
Beschrijving

Communicable Diseases, Active

Datatype

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0205177
Concurrent severe medical problems unrelated to the malignancy which would significantly limit full compliance with the study or expose the patient to extreme risk.
Beschrijving

Disease, Severe

Datatype

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0205082
Concurrent other chemotherapy or investigational therapy.
Beschrijving

Chemotherapy Regimen, Other; Experimental drug, Other

Datatype

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0205394
UMLS CUI [2,1]
C0304229
UMLS CUI [2,2]
C0205394
Patient of child bearing potential, not practicing adequate contraception (barrier method or IUD for three months before the start of the study and agree to continue for at least 4 weeks after the end of the study).
Beschrijving

Childbearing potential, Contraceptive methods

Datatype

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
Patient who is pregnant or lactating.
Beschrijving

Pregnancy; Breast Feeding

Datatype

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0006147
Use of an investigational drug within 30 days or 5 half-lives (whichever is longer) preceding the first dose of study medication.
Beschrijving

Experimental drug, Previous

Datatype

boolean

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0205156
Prior treatment with Topotecan.
Beschrijving

Topotecan, Previous

Datatype

boolean

Alias
UMLS CUI [1,1]
C0146224
UMLS CUI [1,2]
C0205156
Eligibility Determination
Beschrijving

Eligibility Determination

Alias
UMLS CUI-1
C0013893
The patient:
Beschrijving

Eligibility Determination

Datatype

text

Alias
UMLS CUI [1]
C0013893
Telephone Randomization
Beschrijving

Telephone Randomization

Alias
UMLS CUI-1
C0034656
UMLS CUI-2
C0039457
Has the patient been registered and randomized using the centralized telephone system?
Beschrijving

Randomization, Telephone

Datatype

boolean

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C0039457
If ’Yes’ please record the patient’s randomization number.
Beschrijving

Randomization, Numbers

Datatype

integer

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C0237753
If ’Yes’ please indicate the patient’s randomization treatment arm.
Beschrijving

Randomization, Protocol Treatment Arm

Datatype

text

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C1522541
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Similar models

Screening

1 Formulieren
  1. StudyEvent: ODM
    1. Screening
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Institution name, Identifier
Item
Center Number
integer
C1301943 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Patient number
Item
Patient Number
integer
C1830427 (UMLS CUI [1])
Person Initials
Item
Patient Initials
text
C2986440 (UMLS CUI [1])
Date of visit
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Item Group
Demography
C0011298 (UMLS CUI-1)
Patient date of birth
Item
Date of Birth
date
C0421451 (UMLS CUI [1])
Item
Gender
text
C0079399 (UMLS CUI [1])
Gender
Code List
Gender
CL Item
Female (1)
Item
Race
text
C0034510 (UMLS CUI [1])
Racial group
Code List
Race
CL Item
White (1)
CL Item
Black (2)
CL Item
Oriental (3)
CL Item
Other, specify (4)
Racial group
Item
Race, specify
text
C0034510 (UMLS CUI [1])
Item Group
Vital Signs
C0518766 (UMLS CUI-1)
Item
Temperature
text
C0886414 (UMLS CUI [1,1])
C0449444 (UMLS CUI [1,2])
Body temperature measurement, Route
Code List
Temperature
CL Item
Oral (1)
CL Item
Axillary  (2)
CL Item
Rectal  (3)
CL Item
Tympanic (4)
Item
Temperature
text
C0005903 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])
Body Temperature, Unit of Measure
Code List
Temperature
CL Item
°C (1)
CL Item
°F (2)
Body Temperature
Item
Temperature
float
C0005903 (UMLS CUI [1])
Systolic Pressure, Sitting position
Item
After 5 Minutes Sitting - Sitting Blood Pressure - Systolic
integer
C0871470 (UMLS CUI [1,1])
C0277814 (UMLS CUI [1,2])
Diastolic blood pressure, Sitting position
Item
After 5 Minutes Sitting - Sitting Blood Pressure - Diastolic
integer
C0428883 (UMLS CUI [1,1])
C0277814 (UMLS CUI [1,2])
Heart rate while sitting
Item
After 5 Minutes Sitting - Pulse
integer
C2029904 (UMLS CUI [1])
Item Group
History of Cervical Carcinoma
C0302592 (UMLS CUI-1)
C0262926 (UMLS CUI-2)
Cervix carcinoma, Date of diagnosis
Item
Record the date of diagnosis of primary disease
date
C0302592 (UMLS CUI [1,1])
C2316983 (UMLS CUI [1,2])
Cervix carcinoma, End Date
Item
Record the date of the last recurrence or mark the N/A box if no remission obtained.
date
C0302592 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Item
Record the date of the last recurrence or mark the N/A box if no remission obtained.
text
C0302592 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Cervix carcinoma, End Date
Code List
Record the date of the last recurrence or mark the N/A box if no remission obtained.
CL Item
Not Applicable (1)
Item Group
Previous Surgical Procedures for Cervical Carcinoma
C0302592 (UMLS CUI-1)
C0543467 (UMLS CUI-2)
C0205156 (UMLS CUI-3)
Cervix carcinoma, Operative Surgical Procedures, Previous
Item
Has the patient had any surgical procedure(s) as therapy for cervical carcinoma?
boolean
C0302592 (UMLS CUI [1,1])
C0543467 (UMLS CUI [1,2])
C0205156 (UMLS CUI [1,3])
Cervix carcinoma, Operative Surgical Procedures
Item
Surgical Procedure
text
C0302592 (UMLS CUI [1,1])
C0543467 (UMLS CUI [1,2])
Cervix carcinoma, Operative Surgical Procedures, Date in time
Item
Date
date
C0302592 (UMLS CUI [1,1])
C0543467 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Item Group
Previous Chemotherapy for Cervical Carcinoma
C0392920 (UMLS CUI-1)
C0205156 (UMLS CUI-2)
C0205156 (UMLS CUI-3)
Cervix carcinoma, Chemotherapy Regimen, Previous
Item
Has the patient had any chemotherapy as therapy for cervical carcinoma?
boolean
C0392920 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C0205156 (UMLS CUI [1,3])
Cervix carcinoma, Chemotherapy Regimen
Item
Regimen
text
C0392920 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
Cervix carcinoma, Chemotherapy Regimen, Cumulative Dose
Item
Cumulative Dose
text
C0392920 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C2986497 (UMLS CUI [1,3])
Cervix carcinoma, Chemotherapy Regimen, Start Date
Item
Start Date
date
C0392920 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,3])
Cervix carcinoma, Chemotherapy Regimen, End Date
Item
End Date
date
C0392920 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,3])
Cervix carcinoma, Chemotherapy Regimen, Best Overall Response
Item
Best Overall Response Code
text
C0392920 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C2986560 (UMLS CUI [1,3])
Cervix carcinoma, Chemotherapy Regimen, Response Duration
Item
If complete or partial response, duration of response (Weeks)
integer
C0392920 (UMLS CUI [1,1])
C0392920 (UMLS CUI [1,2])
C0237585 (UMLS CUI [1,3])
Cervix carcinoma, Chemotherapy Regimen, Radiation Sensitizing Agents
Item
Radiation Sensitizer
text
C0392920 (UMLS CUI [1,1])
C0392920 (UMLS CUI [1,2])
C0034541 (UMLS CUI [1,3])
Item Group
Previous Biological Therapy or Immunotherapy for Cervical Carcinoma
C0302592 (UMLS CUI-1)
C1531518 (UMLS CUI-2)
C0302592 (UMLS CUI-4)
C0021083 (UMLS CUI-5)
Cervix carnoma, Biological Therapy; Cervix carcinoma, Immunotherapy
Item
Has the patient had any biological therapy or immunotherapy for cervical carcinoma?
boolean
C0302592 (UMLS CUI [1,1])
C1531518 (UMLS CUI [1,2])
C0302592 (UMLS CUI [2,1])
C0021083 (UMLS CUI [2,2])
Cervix carnoma, Biological Therapy, Therapeutic regimen; Cervix carcinoma, Immunotherapy, Therapeutic regimen
Item
Regimen
text
C0302592 (UMLS CUI [1,1])
C1531518 (UMLS CUI [1,2])
C1276413 (UMLS CUI [1,3])
C0302592 (UMLS CUI [2,1])
C0021083 (UMLS CUI [2,2])
C1276413 (UMLS CUI [2,3])
Cervix carnoma, Biological Therapy, Therapeutic procedure; Cervix carcinoma, Immunotherapy, Therapeutic procedure
Item
Therapy
text
C0302592 (UMLS CUI [1,1])
C1531518 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,3])
C0302592 (UMLS CUI [2,1])
C0021083 (UMLS CUI [2,2])
C0087111 (UMLS CUI [2,3])
Cervix carnoma, Biological Therapy, Cumulative Dose; Cervix carcinoma, Immunotherapy, Cumulative Dose
Item
Cumulative Dose
text
C0302592 (UMLS CUI [1,1])
C1531518 (UMLS CUI [1,2])
C2986497 (UMLS CUI [1,3])
C0302592 (UMLS CUI [2,1])
C0021083 (UMLS CUI [2,2])
C2986497 (UMLS CUI [2,3])
Cervix carnoma, Biological Therapy, Start Date; Cervix carcinoma, Immunotherapy, Start Date
Item
Start Date
date
C0302592 (UMLS CUI [1,1])
C1531518 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,3])
C0302592 (UMLS CUI [2,1])
C0021083 (UMLS CUI [2,2])
C0808070 (UMLS CUI [2,3])
Cervix carnoma, Biological Therapy, End Date; Cervix carcinoma, Immunotherapy, End Date
Item
End Date
date
C0302592 (UMLS CUI [1,1])
C1531518 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,3])
C0302592 (UMLS CUI [2,1])
C0021083 (UMLS CUI [2,2])
C0806020 (UMLS CUI [2,3])
Cervix carnoma, Biological Therapy, Best Overall Response; Cervix carcinoma, Immunotherapy, Best Overall Response
Item
Best Overall Response Code
text
C0302592 (UMLS CUI [1,1])
C1531518 (UMLS CUI [1,2])
C2986560 (UMLS CUI [1,3])
C0302592 (UMLS CUI [2,1])
C0021083 (UMLS CUI [2,2])
C2986560 (UMLS CUI [2,3])
Cervix carnoma, Biological Therapy, Response Duration; Cervix carcinoma, Immunotherapy, Response Duration
Item
If complete or partial response, duration of response (Weeks)
integer
C0302592 (UMLS CUI [1,1])
C1531518 (UMLS CUI [1,2])
C0237585 (UMLS CUI [1,3])
C0302592 (UMLS CUI [2,1])
C0021083 (UMLS CUI [2,2])
C0237585 (UMLS CUI [2,3])
Item Group
Previous Radiotherapy for Cervical Carcinoma
C0302592 (UMLS CUI-1)
C1522449 (UMLS CUI-2)
Cervix carcinoma, Therapeutic radiology procedure
Item
Has the patient had any radiotherapy as therapy for cervical carcinoma?
boolean
C0302592 (UMLS CUI [1,1])
C1522449 (UMLS CUI [1,2])
Cervix carcinoma, Therapeutic radiology procedure, Radiation Field
Item
Field Site
text
C0302592 (UMLS CUI [1,1])
C1522449 (UMLS CUI [1,2])
C1882536 (UMLS CUI [1,3])
Cervix carcinoma, Therapeutic radiology procedure, Start Date
Item
Start Date
date
C0302592 (UMLS CUI [1,1])
C1522449 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,3])
Cervix carcinoma, Therapeutic radiology procedure, End Date
Item
End Date
date
C0302592 (UMLS CUI [1,1])
C1522449 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,3])
Cervix carcinoma, Therapeutic radiology procedure, Best Overall Response
Item
Best Overall Response Code
text
C0302592 (UMLS CUI [1,1])
C1522449 (UMLS CUI [1,2])
C2986560 (UMLS CUI [1,3])
Item Group
Toxicities Related to Previous Therapy for Cervical Carcinoma
C0302592 (UMLS CUI-1)
C0087111 (UMLS CUI-2)
C0013221 (UMLS CUI-3)
Cervix carcinoma, Therapeutic procedures, Drug toxicity
Item
Does the patient have any residual toxicities related to therapy for cervical carcinoma?
boolean
C0302592 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C0013221 (UMLS CUI [1,3])
Cervix carcinoma, Therapeutic procedures, Drug toxicity
Item
Toxicity
text
C0302592 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C0013221 (UMLS CUI [1,3])
Cervix carcinoma, Therapeutic procedures, Drug toxicity, Toxicity Grade
Item
NCI Grade
text
C0302592 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C0013221 (UMLS CUI [1,3])
C2826262 (UMLS CUI [1,4])
Cervix carcinoma, Therapeutic procedures, Drug toxicity
Item
Previous Therapy
text
C0302592 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C0013221 (UMLS CUI [1,3])
C2826262 (UMLS CUI [1,4])
Item Group
12-Lead Electrocardiogram
C0430456 (UMLS CUI-1)
12 lead ECG, Date in time
Item
Date Performed
date
C0430456 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Finding
text
C0430456 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
12 lead ECG, Result
Code List
Finding
CL Item
Normal/no clinically significant abnormality (1)
CL Item
Clinically significant abnormality (2)
Item Group
Diagnostic Studies for Tumor Assessment
C0302592 (UMLS CUI-1)
C3889740 (UMLS CUI-2)
Item
Diagnostic Procedure
text
C0430022 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
C0430022 (UMLS CUI [1,3])
Cervix carcinoma, Tumor Results Assessment Test, Diagnostic Procedure
Code List
Diagnostic Procedure
CL Item
Chest X-ray (1)
CL Item
Chest CT or MRI Scan (2)
CL Item
Pelvic CT or MRI Scan (3)
CL Item
Abdominal CT or MRI Scan (4)
CL Item
Radionuclide Bone Scan (5)
CL Item
Head CT or MRI Scan (6)
Cervix carcinoma, Tumor Results Assessment Test, Date in time
Item
Date Performed
date
C0430022 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Item
Result
text
C0430022 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
Cervix carcinoma, Tumor Results Assessment Test, Result
Code List
Result
CL Item
Normal/ no clinically significant abnormality (1)
CL Item
Clinically significant abnormality (2)
CL Item
Not Done (3)
Item Group
Ongoing Medical Conditions associated with Cervical Carcinoma
C0302592 (UMLS CUI-1)
C0348080 (UMLS CUI-2)
C0332281 (UMLS CUI-3)
Cervix carcinoma, Condition, Associated
Item
Does the patient have any ongoing medical condition(s) that is associated or possibly associated with cervical carcinoma?
boolean
C0302592 (UMLS CUI [1,1])
C0348080 (UMLS CUI [1,2])
C0332281 (UMLS CUI [1,3])
Cervix carcinoma, Condition, Associated
Item
Condition
text
C0302592 (UMLS CUI [1,1])
C0348080 (UMLS CUI [1,2])
C0332281 (UMLS CUI [1,3])
Cervix carcinoma, Condition, Associated, National Cancer Institute common terminology criteria for adverse event grade finding
Item
NCI Grade
text
C0302592 (UMLS CUI [1,1])
C0348080 (UMLS CUI [1,2])
C0332281 (UMLS CUI [1,3])
C3887242 (UMLS CUI [1,4])
Cervix carcinoma, Condition, Associated, Start Date
Item
Year of first Diagnosis
integer
C0302592 (UMLS CUI [1,1])
C0348080 (UMLS CUI [1,2])
C0332281 (UMLS CUI [1,3])
C0808070 (UMLS CUI [1,4])
Item Group
Significant Medical/Surgical History and Physical Examination
C0262926 (UMLS CUI-1)
C0489540 (UMLS CUI-2)
C0031809 (UMLS CUI-3)
Medical History; History of surgical procedures
Item
Is the patient suffering from or has she ever suffered from any significant medical or surgical condition (other than cervical carcinoma or conditions related to therapy for cervical carcinoma - page 6)?
boolean
C0262926 (UMLS CUI [1])
C0489540 (UMLS CUI [2])
Medical History, Diagnosis; History of surgical procedures, Diagnosis; Physical Examination, Diagnosis
Item
Diagnosis
text
C0262926 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
C1948041 (UMLS CUI [2,1])
C0011900 (UMLS CUI [2,2])
C0031809 (UMLS CUI [3,1])
C0011900 (UMLS CUI [3,2])
Medical History, Diagnosis, National Cancer Institute common terminology criteria for adverse event grade finding; History of surgical procedures, Diagnosis, National Cancer Institute common terminology criteria for adverse event grade finding; Physical Examination, Diagnosis, National Cancer Institute common terminology criteria for adverse event grade finding
Item
NCI Grade
text
C0262926 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
C3887242 (UMLS CUI [1,3])
C1948041 (UMLS CUI [2,1])
C0011900 (UMLS CUI [2,2])
C3887242 (UMLS CUI [2,3])
C0031809 (UMLS CUI [3,1])
C0011900 (UMLS CUI [3,2])
C3887242 (UMLS CUI [3,3])
Medical History, Diagnosis, Start Date; History of surgical procedures, Diagnosis, Start Date; Physical Examination, Diagnosis, Start Date
Item
Year of first Diagnosis
date
C0262926 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,3])
C1948041 (UMLS CUI [2,1])
C0011900 (UMLS CUI [2,2])
C0808070 (UMLS CUI [2,3])
C0031809 (UMLS CUI [3,1])
C0011900 (UMLS CUI [3,2])
C0808070 (UMLS CUI [3,3])
Medical History, Diagnosis, In the past; History of surgical procedures, Diagnosis, In the past; Physical Examination, Diagnosis, In the past
Item
Past
boolean
C0262926 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
C1444637 (UMLS CUI [1,3])
C1948041 (UMLS CUI [2,1])
C0011900 (UMLS CUI [2,2])
C1444637 (UMLS CUI [2,3])
C0031809 (UMLS CUI [3,1])
C0011900 (UMLS CUI [3,2])
C1444637 (UMLS CUI [3,3])
Medical History, Diagnosis, Current; History of surgical procedures, Diagnosis, Current; Physical Examination, Diagnosis, Current
Item
Current/ Active
boolean
C0262926 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
C0521116 (UMLS CUI [1,3])
C1948041 (UMLS CUI [2,1])
C0011900 (UMLS CUI [2,2])
C0521116 (UMLS CUI [2,3])
C0031809 (UMLS CUI [3,1])
C0011900 (UMLS CUI [3,2])
C0521116 (UMLS CUI [3,3])
Item Group
Pior and Concomitant Medication
C2347852 (UMLS CUI-1)
C2826257 (UMLS CUI-2)
Prior Medication Usage
Item
Has the patient taken any medication in the past 30 days? (Exclude previous chemotherapy, immunotherapy, biologic therapy or radiotherapy, which should be recorded on pages 3, 4, and 5.)
boolean
C2826257 (UMLS CUI [1])
Prior Medication Usage, Medication name
Item
Drug Name (Trade Name Preferred)
text
C2826257 (UMLS CUI [1,1])
C2360065 (UMLS CUI [1,2])
Prior Medication Usage, Unit of Measure, Medication Dose
Item
Unit Dose
text
C2826257 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])
C3174092 (UMLS CUI [1,3])
Prior Medication Usage, Frequencies
Item
Frequency
text
C2826257 (UMLS CUI [1,1])
C0439603 (UMLS CUI [1,2])
Prior Medication Usage, Drug Administration Routes
Item
Route
text
C2826257 (UMLS CUI [1,1])
C0013153 (UMLS CUI [1,2])
Prior Medication Usage, Disease
Item
Medical Illness/ Diagnosis (or symptom in ab- sence of diagnosis)
text
C2826257 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
Prior Medication Usage, Start Date
Item
Start Date
date
C2826257 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Prior Medication Usage, End Date
Item
End Date
date
C2826257 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Prior Medication Usage, Continuous
Item
If Continuing mark box
date
C2826257 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
Item Group
Inclusion Criteria
C1512693 (UMLS CUI-1)
Informed Consent
Item
Written informed consent.
boolean
C0021430 (UMLS CUI [1])
Age
Item
At least 18 years of age.
boolean
C0001779 (UMLS CUI [1])
Cervix carcinoma, Squamous cell carcinoma
Item
Histologic documentation of squamous cell cervical cancer.
boolean
C0302592 (UMLS CUI [1,1])
C0007137 (UMLS CUI [1,2])
Cervix carcinoma recurrent; Cervix carcinoma, Advanced phase, Locally; Cervix carcinoma, Metastatic from
Item
Patient with recurrent, locally advanced or metastatic cervical cancer.
boolean
C0278579 (UMLS CUI [1])
C0302592 (UMLS CUI [2,1])
C0205179 (UMLS CUI [2,2])
C1517927 (UMLS CUI [2,3])
C0302592 (UMLS CUI [3,1])
C0332295 (UMLS CUI [3,2])
Chemotherapy Regimen, Eligibility Determination
Item
Patient is eligible with respect to prior chemotherapy if she received one of the following: 1) Chemotherapy for first-line treatment 2) Chemotherapy for first-line treatment and chemotherapy as a radiosensitizer or 3) Chemotherapy as a radiosensitizer.
boolean
C0392920 (UMLS CUI [1,1])
C0013893 (UMLS CUI [1,2])
Radiotherapy to Pelvis, Previous
Item
At least 4 weeks since prior pelvic radiation. The measurable lesion(s) may be in the field(s) of prior radiation if at least 6 weeks have elapsed since the last radiotherapy treatment and providing that the lesion is demonstrated, by CT scan, to be progressing.
boolean
C1536155 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
Lesion
Item
Presence of at least one bidimensionally measurable, non-CNS lesion (indicator lesion) defined by diagnostic studies including CT or MRI scan. • Measurable disease on CT or MRI scan must have both diameters ≥ 1 cm. • Measurable disease on chest x-ray must have both diameters ≥ 2cm. • Palpable tumor masses that cannot be evaluated radiologically must have two diameters ≥ 1 cm.
boolean
C0221198 (UMLS CUI [1])
Curative Surgery, Eligibility Determination
Item
Patient is not considered to be a candidate for curvative surgery.
boolean
C1511562 (UMLS CUI [1,1])
C0013893 (UMLS CUI [1,2])
Operative Surgical Procedures, Complete Recovery
Item
Patient has completely recovered from recent surgery.
boolean
C0543467 (UMLS CUI [1,1])
C2826210 (UMLS CUI [1,2])
Chemotherapy Regimen, Past; Biological treatment, Past
Item
At least 4 weeks since last chemotherapy or biologic therapy. No concurrent biologic therapy or immunotherapy is allowed.
boolean
C0392920 (UMLS CUI [1,1])
C1444637 (UMLS CUI [1,2])
C1531518 (UMLS CUI [2,1])
C1444637 (UMLS CUI [2,2])
Laboratory Procedures, Finding
Item
Laboratory values as follows: • Hemoglobin ≥ 8.0 g/dL (after transfusion if needed) • WBC ≥ 3,500/mm3 • Neutrophils ≥ 1,500/mm3 • Platelets ≥ 100,000/mm3 • Creatinine ≤ 1.5 mg/dL (133 umol/L) or creatinine clearance ≥ 60 mL/min. If the creatinine clearance is between 40ml/min - 60ml/min, a 24 hour clearance is required. If the measurement remains between 40 ml/min - 60 ml/min, the patient should be dose reduced 1 dose level to start the study. • Serum bilirubin ≤ 2.0 mg/dL (≤ 35 umol/L) • SGOT/AST, SGPT/ALT, and alkaline phosphatase ≤ 2 times the upper limit of normal if liver metastases are absent by abdominal CT or MRI scan or ≤ 5 times the upper limit of normal if liver metastases are present.
boolean
C0022885 (UMLS CUI [1,1])
C0243095 (UMLS CUI [1,2])
ECOG performance status; Life expectancy
Item
Performance status ≤ 2 (GOG Scale, protocol Appendix F) and life expectancy ≥ 3 months.
boolean
C1520224 (UMLS CUI [1,1])
C0023671 (UMLS CUI [1,2])
Item Group
Exclusion Criteria
C0680251 (UMLS CUI-1)
Vomiting, Uncontrolled
Item
Patient with uncontrolled emesis, regardless of etiology.
text
C0042963 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
Gastrointestinal Diseases
Item
Any condition of the GI tract which would affect GI absorption or motility (e.g. autonomic neuropathy, active gastric or duodenal ulcers, certain gastrointestinal surgeries). Patients receiving cisapride to maintain motility or gastric emptying are also excluded.
boolean
C0017178 (UMLS CUI [1])
Cervix carcinoma, Adenocarcinoma
Item
Histologic documentation of adenocarcinoma of the cervix.
boolean
C0302592 (UMLS CUI [1,1])
C0001418 (UMLS CUI [1,2])
Malignant Neoplasms, Previous
Item
Concomitant malignancies or previous malignancies within the last five years, with the exception of adequately treated basal or squamous cell carcinoma of the skin.
boolean
C0006826 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
Communicable Diseases, Active
Item
Active infection.
boolean
C0009450 (UMLS CUI [1,1])
C0205177 (UMLS CUI [1,2])
Disease, Severe
Item
Concurrent severe medical problems unrelated to the malignancy which would significantly limit full compliance with the study or expose the patient to extreme risk.
boolean
C0012634 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
Chemotherapy Regimen, Other; Experimental drug, Other
Item
Concurrent other chemotherapy or investigational therapy.
boolean
C0392920 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0304229 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
Childbearing potential, Contraceptive methods
Item
Patient of child bearing potential, not practicing adequate contraception (barrier method or IUD for three months before the start of the study and agree to continue for at least 4 weeks after the end of the study).
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Pregnancy; Breast Feeding
Item
Patient who is pregnant or lactating.
boolean
C0032961 (UMLS CUI [1,1])
C0006147 (UMLS CUI [1,2])
Experimental drug, Previous
Item
Use of an investigational drug within 30 days or 5 half-lives (whichever is longer) preceding the first dose of study medication.
boolean
C0304229 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
Topotecan, Previous
Item
Prior treatment with Topotecan.
boolean
C0146224 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
Item Group
Eligibility Determination
C0013893 (UMLS CUI-1)
Item
The patient:
text
C0013893 (UMLS CUI [1])
Eligibility Determination
Code List
The patient:
CL Item
is eligible to participate in the study.  (1)
CL Item
is not eligible to participate in the study. (2)
Item Group
Telephone Randomization
C0034656 (UMLS CUI-1)
C0039457 (UMLS CUI-2)
Randomization, Telephone
Item
Has the patient been registered and randomized using the centralized telephone system?
boolean
C0034656 (UMLS CUI [1,1])
C0039457 (UMLS CUI [1,2])
Randomization, Numbers
Item
If ’Yes’ please record the patient’s randomization number.
integer
C0034656 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Item
If ’Yes’ please indicate the patient’s randomization treatment arm.
text
C0034656 (UMLS CUI [1,1])
C1522541 (UMLS CUI [1,2])
Randomization, Protocol Treatment Arm
Code List
If ’Yes’ please indicate the patient’s randomization treatment arm.
CL Item
Oral topotecan daily x 5 days (1)
CL Item
Oral topotecan 5 days on, 2 days off for 3 weeks (2)
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