ID

37159

Description

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

Keywords

Versions (1)
  1. 7/5/19 7/5/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

July 5, 2019

DOI

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License

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

English

Screening

1 forms  
  1. StudyEvent: ODM
    1. Screening
Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
Center Number
Description

Institution name, Identifier

Data type

integer

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

Patient number

Data type

integer

Alias
UMLS CUI [1]
C1830427
Patient Initials
Description

Person Initials

Data type

text

Alias
UMLS CUI [1]
C2986440
Visit Date
Description

Date of visit

Data type

date

Alias
UMLS CUI [1]
C1320303
Demography
Description

Demography

Alias
UMLS CUI-1
C0011298
Date of Birth
Description

Patient date of birth

Data type

date

Alias
UMLS CUI [1]
C0421451
Gender
Description

Gender

Data type

text

Alias
UMLS CUI [1]
C0079399
Race
Description

Racial group

Data type

text

Alias
UMLS CUI [1]
C0034510
Race, specify
Description

Racial group

Data type

text

Alias
UMLS CUI [1]
C0034510
Vital Signs
Description

Vital Signs

Alias
UMLS CUI-1
C0518766
Temperature
Description

Body temperature measurement, Route

Data type

text

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

Body Temperature, Unit of Measure

Data type

text

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

Body Temperature

Data type

float

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

Systolic Pressure, Sitting position

Data type

integer

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

Diastolic blood pressure, Sitting position

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1,1]
C0428883
UMLS CUI [1,2]
C0277814
mmHg
After 5 Minutes Sitting - Pulse
Description

Heart rate while sitting

Data type

integer

Measurement units
  • bpm
Alias
UMLS CUI [1]
C2029904
bpm
History of Cervical Carcinoma
Description

History of Cervical Carcinoma

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

Cervix carcinoma, Date of diagnosis

Data type

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.
Description

Cervix carcinoma, End Date

Data type

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.
Description

Cervix carcinoma, End Date

Data type

text

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

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?
Description

Cervix carcinoma, Operative Surgical Procedures, Previous

Data type

boolean

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

Cervix carcinoma, Operative Surgical Procedures

Data type

text

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

Cervix carcinoma, Operative Surgical Procedures, Date in time

Data type

date

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

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?
Description

Cervix carcinoma, Chemotherapy Regimen, Previous

Data type

boolean

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

Cervix carcinoma, Chemotherapy Regimen

Data type

text

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

Cervix carcinoma, Chemotherapy Regimen, Cumulative Dose

Data type

text

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

Cervix carcinoma, Chemotherapy Regimen, Start Date

Data type

date

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

Cervix carcinoma, Chemotherapy Regimen, End Date

Data type

date

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

Cervix carcinoma, Chemotherapy Regimen, Best Overall Response

Data type

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)
Description

Cervix carcinoma, Chemotherapy Regimen, Response Duration

Data type

integer

Measurement units
  • weeks
Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0392920
UMLS CUI [1,3]
C0237585
weeks
Radiation Sensitizer
Description

Cervix carcinoma, Chemotherapy Regimen, Radiation Sensitizing Agents

Data type

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
Description

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?
Description

Cervix carnoma, Biological Therapy; Cervix carcinoma, Immunotherapy

Data type

boolean

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

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

Data type

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
Description

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

Data type

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
Description

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

Data type

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
Description

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

Data type

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
Description

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

Data type

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
Description

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

Data type

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)
Description

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

Data type

integer

Measurement units
  • 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
Description

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?
Description

Cervix carcinoma, Therapeutic radiology procedure

Data type

boolean

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

Cervix carcinoma, Therapeutic radiology procedure, Radiation Field

Data type

text

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

Cervix carcinoma, Therapeutic radiology procedure, Start Date

Data type

date

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

Cervix carcinoma, Therapeutic radiology procedure, End Date

Data type

date

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

Cervix carcinoma, Therapeutic radiology procedure, Best Overall Response

Data type

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
Description

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?
Description

Cervix carcinoma, Therapeutic procedures, Drug toxicity

Data type

boolean

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

Cervix carcinoma, Therapeutic procedures, Drug toxicity

Data type

text

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

Cervix carcinoma, Therapeutic procedures, Drug toxicity, Toxicity Grade

Data type

text

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

Cervix carcinoma, Therapeutic procedures, Drug toxicity

Data type

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
Description

12-Lead Electrocardiogram

Alias
UMLS CUI-1
C0430456
Date Performed
Description

12 lead ECG, Date in time

Data type

date

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

12 lead ECG, Result

Data type

text

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

Diagnostic Studies for Tumor Assessment

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

Cervix carcinoma, Tumor Results Assessment Test, Diagnostic Procedure

Data type

text

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

Cervix carcinoma, Tumor Results Assessment Test, Date in time

Data type

date

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

Cervix carcinoma, Tumor Results Assessment Test, Result

Data type

text

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

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?
Description

Cervix carcinoma, Condition, Associated

Data type

boolean

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

Cervix carcinoma, Condition, Associated

Data type

text

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

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

Data type

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
Description

Cervix carcinoma, Condition, Associated, Start Date

Data type

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
Description

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)?
Description

Medical History; History of surgical procedures

Data type

boolean

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

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

Data type

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
Description

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

Data type

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
Description

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

Data type

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
Description

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

Data type

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
Description

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

Data type

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
Description

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.)
Description

Prior Medication Usage

Data type

boolean

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

Prior Medication Usage, Medication name

Data type

text

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

Prior Medication Usage, Unit of Measure, Medication Dose

Data type

text

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

Prior Medication Usage, Frequencies

Data type

text

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

Prior Medication Usage, Drug Administration Routes

Data type

text

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

Prior Medication Usage, Disease

Data type

text

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

Prior Medication Usage, Start Date

Data type

date

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

Prior Medication Usage, End Date

Data type

date

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

Prior Medication Usage, Continuous

Data type

date

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

Inclusion Criteria

Alias
UMLS CUI-1
C1512693
Written informed consent.
Description

Informed Consent

Data type

boolean

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

Age

Data type

boolean

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

Cervix carcinoma, Squamous cell carcinoma

Data type

boolean

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

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

Data type

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.
Description

Chemotherapy Regimen, Eligibility Determination

Data type

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.
Description

Radiotherapy to Pelvis, Previous

Data type

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.
Description

Lesion

Data type

boolean

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

Curative Surgery, Eligibility Determination

Data type

boolean

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

Operative Surgical Procedures, Complete Recovery

Data type

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.
Description

Chemotherapy Regimen, Past; Biological treatment, Past

Data type

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.
Description

Laboratory Procedures, Finding

Data type

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.
Description

ECOG performance status; Life expectancy

Data type

boolean

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

Exclusion Criteria

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

Vomiting, Uncontrolled

Data type

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.
Description

Gastrointestinal Diseases

Data type

boolean

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

Cervix carcinoma, Adenocarcinoma

Data type

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.
Description

Malignant Neoplasms, Previous

Data type

boolean

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

Communicable Diseases, Active

Data type

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.
Description

Disease, Severe

Data type

boolean

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

Chemotherapy Regimen, Other; Experimental drug, Other

Data type

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).
Description

Childbearing potential, Contraceptive methods

Data type

boolean

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

Pregnancy; Breast Feeding

Data type

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.
Description

Experimental drug, Previous

Data type

boolean

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

Topotecan, Previous

Data type

boolean

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

Eligibility Determination

Alias
UMLS CUI-1
C0013893
The patient:
Description

Eligibility Determination

Data type

text

Alias
UMLS CUI [1]
C0013893
Telephone Randomization
Description

Telephone Randomization

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

Randomization, Telephone

Data type

boolean

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

Randomization, Numbers

Data type

integer

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

Randomization, Protocol Treatment Arm

Data type

text

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

Screening

1 forms
  1. StudyEvent: ODM
    1. Screening
Name
Type
Description | Question | Decode (Coded Value)
Data type
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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