ID

37677

Beschreibung

Study ID: 104864/517 Clinical Study ID: 104864/517 Study Title: A Phase I Study of Oral Topotecan as a Radiosensitizing Agent in Patients With Rectal Cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00158886 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Topotecan + Radiation therapy Trade Name: N/A Study Indication: Rectal Cancer, Carcinoma, Renal Cell

Stichworte

Versionen (1)
  1. 16.08.19 16.08.19 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

16. August 2019

DOI

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Lizenz

Creative Commons BY-NC 3.0
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Oral Topotecan as Radiosensitizing Agent in Patients with Rectal Cancer; NCT00158886

Englisch

Screening

1 Formulare  
  1. StudyEvent: ODM
    1. Screening
Administrative Data
Beschreibung

Administrative Data

Alias
UMLS CUI-1
C1320722
Center number
Beschreibung

Study Coordinating Center, Identification number

Datentyp

integer

Alias
UMLS CUI [1,1]
C2825181
UMLS CUI [1,2]
C1300638
Patient Number
Beschreibung

Patient number

Datentyp

integer

Alias
UMLS CUI [1]
C1830427
Patient Initials
Beschreibung

Person Initials

Datentyp

text

Alias
UMLS CUI [1]
C2986440
Visit Date
Beschreibung

Date of visit

Datentyp

date

Alias
UMLS CUI [1]
C1320303
Demography
Beschreibung

Demography

Alias
UMLS CUI-1
C0011298
Date of Birth
Beschreibung

Patient date of birth

Datentyp

date

Alias
UMLS CUI [1]
C0421451
Gender
Beschreibung

Gender

Datentyp

text

Alias
UMLS CUI [1]
C0079399
Race
Beschreibung

Racial group

Datentyp

text

Alias
UMLS CUI [1]
C0034510
Vital Signs
Beschreibung

Vital Signs

Alias
UMLS CUI-1
C0518766
Height - Unit
Beschreibung

Body Height, Unit of Measure

Datentyp

text

Alias
UMLS CUI [1,1]
C0005890
UMLS CUI [1,2]
C1519795
Height
Beschreibung

Body Height

Datentyp

float

Alias
UMLS CUI [1]
C0005890
Weight - Unit
Beschreibung

Body Weight, Unit of Measure

Datentyp

text

Alias
UMLS CUI [1,1]
C0005910
UMLS CUI [1,2]
C1519795
Weight
Beschreibung

Body Weight

Datentyp

float

Alias
UMLS CUI [1]
C0005910
Temperature - Measurement Site
Beschreibung

Body temperature measurement site

Datentyp

text

Alias
UMLS CUI [1]
C0489453
Temperature - Unit
Beschreibung

Body Temperature, Unit of Measure

Datentyp

text

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

Body Temperature

Datentyp

float

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

Systolic Pressure, Sitting position

Datentyp

integer

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

Diastolic blood pressure, Sitting position

Datentyp

integer

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

Heart rate, Sitting position

Datentyp

integer

Maßeinheiten
  • bpm
Alias
UMLS CUI [1,1]
C0018810
UMLS CUI [1,2]
C0277814
bpm
History of Rectal Carcinoma
Beschreibung

History of Rectal Carcinoma

Alias
UMLS CUI-1
C0007113
UMLS CUI-2
C0262926
Record the date of diagnosis of primary disease
Beschreibung

Rectal Carcinoma, Primary Disorders, Date of diagnosis

Datentyp

date

Alias
UMLS CUI [1,1]
C0007113
UMLS CUI [1,2]
C0277554
UMLS CUI [1,3]
C2316983
Please record the stage of the disease using the TNM staging system - T
Beschreibung

Rectal Carcinoma, TNM clinical staging, primary tumor

Datentyp

text

Alias
UMLS CUI [1,1]
C0007113
UMLS CUI [1,2]
C3258246
UMLS CUI [1,3]
C0677930
Please record the stage of the disease using the TNM staging system - N
Beschreibung

Rectal Carcinoma, TNM clinical staging, Lymph nodes

Datentyp

text

Alias
UMLS CUI [1,1]
C0007113
UMLS CUI [1,2]
C3258246
UMLS CUI [1,3]
C0024204
Please record the stage of the disease using the TNM staging system - M
Beschreibung

Rectal Carcinoma, TNM clinical staging, Neoplasm Metastasis

Datentyp

text

Alias
UMLS CUI [1,1]
C0007113
UMLS CUI [1,2]
C3258246
UMLS CUI [1,3]
C0027627
Tumor size - Height
Beschreibung

Rectal Carcinoma, Tumor Size, Height

Datentyp

float

Maßeinheiten
  • cm
Alias
UMLS CUI [1,1]
C0007113
UMLS CUI [1,2]
C0475440
UMLS CUI [1,3]
C0489786
cm
Tumor size - Width
Beschreibung

Rectal Carcinoma, Tumor Size, Width

Datentyp

float

Maßeinheiten
  • cm
Alias
UMLS CUI [1,1]
C0007113
UMLS CUI [1,2]
C0475440
UMLS CUI [1,3]
C0487742
cm
Tumor size - Diameter
Beschreibung

Rectal Carcinoma, Tumor Size, Diameter

Datentyp

float

Maßeinheiten
  • cm
Alias
UMLS CUI [1,1]
C0007113
UMLS CUI [1,2]
C0475440
UMLS CUI [1,3]
C1301886
cm
Ulceration
Beschreibung

Rectal Carcinoma, Ulceration

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0007113
UMLS CUI [1,2]
C3887532
Tumor Fixation
Beschreibung

Rectal Carcinoma, Fixation

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0007113
UMLS CUI [1,2]
C0185023
Previous Surgical Procedures for Rectal Carcinoma
Beschreibung

Previous Surgical Procedures for Rectal Carcinoma

Alias
UMLS CUI-1
C0007113
UMLS CUI-2
C0543467
UMLS CUI-3
C0205156
Has the patient had any surgical procedures for rectal carcinoma?
Beschreibung

Rectal Carcinoma, Operative Surgical Procedures, Previous

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0007113
UMLS CUI [1,2]
C0543467
UMLS CUI [1,3]
C0205156
Surgical Procedure
Beschreibung

Rectal Carcinoma, Operative Surgical Procedures, Previous

Datentyp

text

Alias
UMLS CUI [1,1]
C0007113
UMLS CUI [1,2]
C0543467
UMLS CUI [1,3]
C0205156
Surgical Procedure
Beschreibung

Rectal Carcinoma, Operative Surgical Procedures, Date in time

Datentyp

text

Alias
UMLS CUI [1,1]
C0007113
UMLS CUI [1,2]
C0543467
UMLS CUI [1,3]
C0011008
12-Lead Electrocardiogram
Beschreibung

12-Lead Electrocardiogram

Alias
UMLS CUI-1
C0430456
Date Performed
Beschreibung

12 lead ECG, Date in time

Datentyp

date

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0011008
Result
Beschreibung

12 lead ECG, Result

Datentyp

text

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

Diagnostic Studies for Tumor Assessment

Alias
UMLS CUI-1
C0007113
UMLS CUI-2
C0220825
UMLS CUI-3
C0430022
Diagnostic Procedure
Beschreibung

Rectal Carcinoma, Evaluation, Diagnostic procedure

Datentyp

text

Alias
UMLS CUI [1,1]
C0007113
UMLS CUI [1,2]
C0220825
UMLS CUI [1,3]
C0430022
Date Performed
Beschreibung

Rectal Carcinoma, Evaluation, Diagnostic procedure, Date in time

Datentyp

date

Alias
UMLS CUI [1,1]
C0007113
UMLS CUI [1,2]
C0220825
UMLS CUI [1,3]
C0430022
UMLS CUI [1,4]
C0011008
Clinically significant?
Beschreibung

Rectal Carcinoma, Evaluation, Diagnostic procedure, Clinical Significance

Datentyp

text

Alias
UMLS CUI [1,1]
C0007113
UMLS CUI [1,2]
C0220825
UMLS CUI [1,3]
C0430022
UMLS CUI [1,4]
C2826293
Not Done
Beschreibung

Rectal Carcinoma, Evaluation, Diagnostic procedure, Not Done

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0007113
UMLS CUI [1,2]
C0220825
UMLS CUI [1,3]
C0430022
UMLS CUI [1,4]
C1272696
Ongoing Medical Conditions Associated with Rectal Carcinoma
Beschreibung

Ongoing Medical Conditions Associated with Rectal Carcinoma

Alias
UMLS CUI-1
C0012634
UMLS CUI-2
C0439849
UMLS CUI-3
C0007113
Does the patient have any ongoing medical condition(s) that is associated or possibly associated with rectal carcinoma?
Beschreibung

Disease, Relationships, Rectal Carcinoma

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0439849
UMLS CUI [1,3]
C0007113
Condition
Beschreibung

Disease, Relationships, Rectal Carcinoma

Datentyp

text

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0439849
UMLS CUI [1,3]
C0007113
NCI Grade
Beschreibung

Disease, Relationships, Rectal Carcinoma, National Cancer Institute common terminology criteria for adverse event grade finding

Datentyp

text

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0439849
UMLS CUI [1,3]
C0007113
UMLS CUI [1,4]
C3887242
Year of first diagnosis
Beschreibung

Disease, Relationships, Rectal Carcinoma, Date of diagnosis

Datentyp

integer

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0439849
UMLS CUI [1,3]
C0007113
UMLS CUI [1,4]
C2316983
Significant Medical/Surgical History and Physical Examination
Beschreibung

Significant Medical/Surgical History and Physical Examination

Alias
UMLS CUI-1
C0262926
UMLS CUI-2
C0489540
UMLS CUI-3
C0031809
Is the patient suffering or has he/she ever suffered from any significant medical or surgical condition?
Beschreibung

Medical History; History of surgical procedures

Datentyp

boolean

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

Medical History, Diagnosis; History of surgical procedures, Diagnosis

Datentyp

text

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0011900
UMLS CUI [2,1]
C1948041
UMLS CUI [2,2]
C0011900
NCI Grade
Beschreibung

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

Datentyp

text

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C3887242
UMLS CUI [2,1]
C1948041
UMLS CUI [2,2]
C3887242
Year of first diagnosis
Beschreibung

Medical History, Date of diagnosis; History of surgical procedures, Date of diagnosis

Datentyp

integer

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C2316983
UMLS CUI [2,1]
C1948041
UMLS CUI [2,2]
C2316983
Past or Current/Active?
Beschreibung

Medical History, Current, Past; History of surgical procedures, Current, Past

Datentyp

text

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C1444637
UMLS CUI [1,3]
C0521116
UMLS CUI [2,1]
C1948041
UMLS CUI [2,2]
C1444637
UMLS CUI [2,3]
C0521116
Prior and Concomitant Medication
Beschreibung

Prior and Concomitant Medication

Alias
UMLS CUI-1
C0013227
UMLS CUI-2
C0205156
UMLS CUI-4
C2347852
Has the patient taken any medication in the past 30 days?
Beschreibung

Concomitant Agent

Datentyp

boolean

Alias
UMLS CUI [1]
C2347852
Drug Name (Trade Name Preferred)
Beschreibung

Concomitant Agent, Medication name

Datentyp

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C2360065
Unit Dose
Beschreibung

Concomitant Agent, Unit of Measure, Dosage

Datentyp

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C1519795
UMLS CUI [1,3]
C0178602
Frequency
Beschreibung

Concomitant Agent, Frequencies

Datentyp

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0439603
Route
Beschreibung

Concomitant Agent, Drug Administration Routes

Datentyp

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0013153
Medical Illness/Diagnosis (or symptom in absence of diagnosis)
Beschreibung

Concomitant Agent, Disease

Datentyp

text

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0012634
Start Date (be as precise as possible)
Beschreibung

Concomitant Medication Start Date

Datentyp

date

Alias
UMLS CUI [1]
C2826734
End Date
Beschreibung

Concomitant Medication End Date

Datentyp

date

Alias
UMLS CUI [1]
C2826744
If Continuing mark box
Beschreibung

Concomitant Medication Ongoing

Datentyp

boolean

Alias
UMLS CUI [1]
C2826666
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI-1
C1512693
Patient with histologically confirmed rectal cancer.
Beschreibung

Rectal Carcinoma, Histology

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0007113
UMLS CUI [1,2]
C0019638
Written informed consent.
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
Patient should be a candidate for preoperative radiotherapy.
Beschreibung

Therapeutic radiology procedure, Preoperative

Datentyp

text

Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C0445204
A primary tumor >= 3cm with a clinical stage of T2, T3 or T4 and any According to the Astler-Coller modification of the Dukes staging system.
Beschreibung

Primary Tumor, TNM clinical staging

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0677930
UMLS CUI [1,2]
C3258246
Patient must be >= 18 years of age.
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
Must have an ECOG performance status <= 2.
Beschreibung

ECOG performance status

Datentyp

boolean

Alias
UMLS CUI [1]
C1520224
Diagnosis of rectal cancer should be no more than 90 days from initial clinic visit or from the start of therapy.
Beschreibung

Rectal Carcinoma, Date of diagnosis

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0007113
UMLS CUI [1,2]
C2316983
Patient must be recovered from prior surgery
Beschreibung

Operative Surgical Procedures, Previous, Complete Recovery

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C0205156
UMLS CUI [1,3]
C2826210
Patient must have a life expectancy >= 3 months.
Beschreibung

Life Expectancy

Datentyp

boolean

Alias
UMLS CUI [1]
C0023671
Laboratory criteria: WBC >= 3000/mm3 Neutrophils >= 1,500/mm3 Platelet count >= 100,000/mm3 Serum creatinine <= 1,5mg/dL (133umol/L) or creatinine clearance > 60mL/min 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.
Beschreibung

Laboratory Procedures

Datentyp

boolean

Alias
UMLS CUI [1]
C0022885
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI-1
C0680251
Patient with primary tumor totally excised at time of diagnosis
Beschreibung

Primary tumor, Excision, Total

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0677930
UMLS CUI [1,2]
C0728940
UMLS CUI [1,3]
C0439810
Patient with recurrent rectal cancer that failed initial treatment
Beschreibung

Rectal Carcinoma, Recurrent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0007113
UMLS CUI [1,2]
C2945760
Patient previously treated with topotecan.
Beschreibung

Topotecan, Previous

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0146224
UMLS CUI [1,2]
C0205156
Patient with active infection.
Beschreibung

Communicable Diseases, Active

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0205177
Any known primary or secondary immunodeficiencies.
Beschreibung

Immunologic Deficiency Syndromes

Datentyp

boolean

Alias
UMLS CUI [1]
C0021051
Any condition of the GI tract which would affect the GI absorption or motility (e.g. autonomic neuropathy, active gastric or duodenal ulcers or certain gastrointestinal surgeries). Patients receiving medication to maintain motility or gastric emptying are also excluded.
Beschreibung

Gastrointestinal Diseases

Datentyp

boolean

Alias
UMLS CUI [1]
C0017178
Patients with uncontrolled emesis, regardless of etiology.
Beschreibung

Vomiting, Uncontrolled

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0042963
UMLS CUI [1,2]
C0205318
Concomitant malignancies or previous malignancies within the last five years, with the exception of adequately treated basal or squamous cell carcinoma of the skin, carcinoma in situ of the cervix or Stage A low grade prostate cancer.
Beschreibung

Malignant Neoplasms, Comorbidity; Malignant Neoplasms, Previous

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0009488
UMLS CUI [2,1]
C0006826
UMLS CUI [2,2]
C0205156
Concurrent severe medical problems unrelated to the malignancy which would significantly limit full compliance with the study or expose the patient to significant risk.
Beschreibung

Comorbidity, Severe

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205082
Patient of child bearing potential, to practicing adequate conception (barrier method or IUD for three months before the start of the study and agree to continue for at least for weeks after the end of the study).
Beschreibung

Childbearing potential, Contraceptive methods

Datentyp

boolean

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

Pregnancy; Breast Feeding

Datentyp

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.
Beschreibung

Study Subject Participation Status

Datentyp

boolean

Alias
UMLS CUI [1]
C2348568
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Ähnliche Modelle

Screening

1 Formulare
  1. StudyEvent: ODM
    1. Screening
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Study Coordinating Center, Identification number
Item
Center number
integer
C2825181 (UMLS CUI [1,1])
C1300638 (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
Male (1)
CL Item
Female (2)
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, please specify (4)
Item Group
Vital Signs
C0518766 (UMLS CUI-1)
Item
Height - Unit
text
C0005890 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])
Body Height, Unit of Measure
Code List
Height - Unit
CL Item
in (1)
CL Item
cm (2)
Body Height
Item
Height
float
C0005890 (UMLS CUI [1])
Item
Weight - Unit
text
C0005910 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])
Body Weight, Unit of Measure
Code List
Weight - Unit
CL Item
lb (1)
CL Item
kg (2)
Body Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Item
Temperature - Measurement Site
text
C0489453 (UMLS CUI [1])
Body temperature measurement site
Code List
Temperature - Measurement Site
CL Item
Oral (1)
CL Item
Axillary (2)
CL Item
Rectal (3)
CL Item
Tympanic (4)
Item
Temperature - Unit
text
C0005903 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])
Body Temperature, Unit of Measure
Code List
Temperature - Unit
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, Sitting position
Item
After 5 Minutes Sitting - Pulse
integer
C0018810 (UMLS CUI [1,1])
C0277814 (UMLS CUI [1,2])
Item Group
History of Rectal Carcinoma
C0007113 (UMLS CUI-1)
C0262926 (UMLS CUI-2)
Rectal Carcinoma, Primary Disorders, Date of diagnosis
Item
Record the date of diagnosis of primary disease
date
C0007113 (UMLS CUI [1,1])
C0277554 (UMLS CUI [1,2])
C2316983 (UMLS CUI [1,3])
Rectal Carcinoma, TNM clinical staging, primary tumor
Item
Please record the stage of the disease using the TNM staging system - T
text
C0007113 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
C0677930 (UMLS CUI [1,3])
Rectal Carcinoma, TNM clinical staging, Lymph nodes
Item
Please record the stage of the disease using the TNM staging system - N
text
C0007113 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
C0024204 (UMLS CUI [1,3])
Rectal Carcinoma, TNM clinical staging, Neoplasm Metastasis
Item
Please record the stage of the disease using the TNM staging system - M
text
C0007113 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
C0027627 (UMLS CUI [1,3])
Rectal Carcinoma, Tumor Size, Height
Item
Tumor size - Height
float
C0007113 (UMLS CUI [1,1])
C0475440 (UMLS CUI [1,2])
C0489786 (UMLS CUI [1,3])
Rectal Carcinoma, Tumor Size, Width
Item
Tumor size - Width
float
C0007113 (UMLS CUI [1,1])
C0475440 (UMLS CUI [1,2])
C0487742 (UMLS CUI [1,3])
Rectal Carcinoma, Tumor Size, Diameter
Item
Tumor size - Diameter
float
C0007113 (UMLS CUI [1,1])
C0475440 (UMLS CUI [1,2])
C1301886 (UMLS CUI [1,3])
Rectal Carcinoma, Ulceration
Item
Ulceration
boolean
C0007113 (UMLS CUI [1,1])
C3887532 (UMLS CUI [1,2])
Rectal Carcinoma, Fixation
Item
Tumor Fixation
boolean
C0007113 (UMLS CUI [1,1])
C0185023 (UMLS CUI [1,2])
Item Group
Previous Surgical Procedures for Rectal Carcinoma
C0007113 (UMLS CUI-1)
C0543467 (UMLS CUI-2)
C0205156 (UMLS CUI-3)
Rectal Carcinoma, Operative Surgical Procedures, Previous
Item
Has the patient had any surgical procedures for rectal carcinoma?
boolean
C0007113 (UMLS CUI [1,1])
C0543467 (UMLS CUI [1,2])
C0205156 (UMLS CUI [1,3])
Rectal Carcinoma, Operative Surgical Procedures, Previous
Item
Surgical Procedure
text
C0007113 (UMLS CUI [1,1])
C0543467 (UMLS CUI [1,2])
C0205156 (UMLS CUI [1,3])
Rectal Carcinoma, Operative Surgical Procedures, Date in time
Item
Surgical Procedure
text
C0007113 (UMLS CUI [1,1])
C0543467 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
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
Result
text
C0430456 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
12 lead ECG, Result
Code List
Result
CL Item
Normal/No clinically significant abnormality (1)
CL Item
Clinically significant abnormality (2)
Item Group
Diagnostic Studies for Tumor Assessment
C0007113 (UMLS CUI-1)
C0220825 (UMLS CUI-2)
C0430022 (UMLS CUI-3)
Item
Diagnostic Procedure
text
C0007113 (UMLS CUI [1,1])
C0220825 (UMLS CUI [1,2])
C0430022 (UMLS CUI [1,3])
Rectal Carcinoma, Evaluation, Diagnostic procedure
Code List
Diagnostic Procedure
CL Item
Chest x-ray (1)
CL Item
Chest CT or MRI Scan (2)
CL Item
Abdominal CT or MRI Scan (3)
CL Item
Pelvic CT or MRI Scan (4)
CL Item
Radionuclide Bone Scan (5)
CL Item
PET Scan (6)
Rectal Carcinoma, Evaluation, Diagnostic procedure, Date in time
Item
Date Performed
date
C0007113 (UMLS CUI [1,1])
C0220825 (UMLS CUI [1,2])
C0430022 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
Item
Clinically significant?
text
C0007113 (UMLS CUI [1,1])
C0220825 (UMLS CUI [1,2])
C0430022 (UMLS CUI [1,3])
C2826293 (UMLS CUI [1,4])
Rectal Carcinoma, Evaluation, Diagnostic procedure, Clinical Significance
Code List
Clinically significant?
CL Item
Normal/no clinically significant abnormality (1)
CL Item
Clinically significant abnormality (2)
Rectal Carcinoma, Evaluation, Diagnostic procedure, Not Done
Item
Not Done
boolean
C0007113 (UMLS CUI [1,1])
C0220825 (UMLS CUI [1,2])
C0430022 (UMLS CUI [1,3])
C1272696 (UMLS CUI [1,4])
Item Group
Ongoing Medical Conditions Associated with Rectal Carcinoma
C0012634 (UMLS CUI-1)
C0439849 (UMLS CUI-2)
C0007113 (UMLS CUI-3)
Disease, Relationships, Rectal Carcinoma
Item
Does the patient have any ongoing medical condition(s) that is associated or possibly associated with rectal carcinoma?
boolean
C0012634 (UMLS CUI [1,1])
C0439849 (UMLS CUI [1,2])
C0007113 (UMLS CUI [1,3])
Disease, Relationships, Rectal Carcinoma
Item
Condition
text
C0012634 (UMLS CUI [1,1])
C0439849 (UMLS CUI [1,2])
C0007113 (UMLS CUI [1,3])
Disease, Relationships, Rectal Carcinoma, National Cancer Institute common terminology criteria for adverse event grade finding
Item
NCI Grade
text
C0012634 (UMLS CUI [1,1])
C0439849 (UMLS CUI [1,2])
C0007113 (UMLS CUI [1,3])
C3887242 (UMLS CUI [1,4])
Disease, Relationships, Rectal Carcinoma, Date of diagnosis
Item
Year of first diagnosis
integer
C0012634 (UMLS CUI [1,1])
C0439849 (UMLS CUI [1,2])
C0007113 (UMLS CUI [1,3])
C2316983 (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 or has he/she ever suffered from any significant medical or surgical condition?
boolean
C0262926 (UMLS CUI [1])
C0489540 (UMLS CUI [2])
Medical History, Diagnosis; History of surgical procedures, Diagnosis
Item
Diagnosis
text
C0262926 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
C1948041 (UMLS CUI [2,1])
C0011900 (UMLS CUI [2,2])
Medical History, National Cancer Institute common terminology criteria for adverse event grade finding; History of surgical procedures, National Cancer Institute common terminology criteria for adverse event grade finding
Item
NCI Grade
text
C0262926 (UMLS CUI [1,1])
C3887242 (UMLS CUI [1,2])
C1948041 (UMLS CUI [2,1])
C3887242 (UMLS CUI [2,2])
Medical History, Date of diagnosis; History of surgical procedures, Date of diagnosis
Item
Year of first diagnosis
integer
C0262926 (UMLS CUI [1,1])
C2316983 (UMLS CUI [1,2])
C1948041 (UMLS CUI [2,1])
C2316983 (UMLS CUI [2,2])
Item
Past or Current/Active?
text
C0262926 (UMLS CUI [1,1])
C1444637 (UMLS CUI [1,2])
C0521116 (UMLS CUI [1,3])
C1948041 (UMLS CUI [2,1])
C1444637 (UMLS CUI [2,2])
C0521116 (UMLS CUI [2,3])
Medical History, Current, Past; History of surgical procedures, Current, Past
Code List
Past or Current/Active?
CL Item
Past (1)
CL Item
Current/Active (2)
Item Group
Prior and Concomitant Medication
C0013227 (UMLS CUI-1)
C0205156 (UMLS CUI-2)
C2347852 (UMLS CUI-4)
Concomitant Agent
Item
Has the patient taken any medication in the past 30 days?
boolean
C2347852 (UMLS CUI [1])
Concomitant Agent, Medication name
Item
Drug Name (Trade Name Preferred)
text
C2347852 (UMLS CUI [1,1])
C2360065 (UMLS CUI [1,2])
Concomitant Agent, Unit of Measure, Dosage
Item
Unit Dose
text
C2347852 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,3])
Concomitant Agent, Frequencies
Item
Frequency
text
C2347852 (UMLS CUI [1,1])
C0439603 (UMLS CUI [1,2])
Concomitant Agent, Drug Administration Routes
Item
Route
text
C2347852 (UMLS CUI [1,1])
C0013153 (UMLS CUI [1,2])
Concomitant Agent, Disease
Item
Medical Illness/Diagnosis (or symptom in absence of diagnosis)
text
C2347852 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
Concomitant Medication Start Date
Item
Start Date (be as precise as possible)
date
C2826734 (UMLS CUI [1])
Concomitant Medication End Date
Item
End Date
date
C2826744 (UMLS CUI [1])
Concomitant Medication Ongoing
Item
If Continuing mark box
boolean
C2826666 (UMLS CUI [1])
Item Group
Inclusion Criteria
C1512693 (UMLS CUI-1)
Rectal Carcinoma, Histology
Item
Patient with histologically confirmed rectal cancer.
boolean
C0007113 (UMLS CUI [1,1])
C0019638 (UMLS CUI [1,2])
Informed Consent
Item
Written informed consent.
boolean
C0021430 (UMLS CUI [1])
Therapeutic radiology procedure, Preoperative
Item
Patient should be a candidate for preoperative radiotherapy.
text
C1522449 (UMLS CUI [1,1])
C0445204 (UMLS CUI [1,2])
Primary Tumor, TNM clinical staging
Item
A primary tumor >= 3cm with a clinical stage of T2, T3 or T4 and any According to the Astler-Coller modification of the Dukes staging system.
boolean
C0677930 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
Age
Item
Patient must be >= 18 years of age.
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
Must have an ECOG performance status <= 2.
boolean
C1520224 (UMLS CUI [1])
Rectal Carcinoma, Date of diagnosis
Item
Diagnosis of rectal cancer should be no more than 90 days from initial clinic visit or from the start of therapy.
boolean
C0007113 (UMLS CUI [1,1])
C2316983 (UMLS CUI [1,2])
Operative Surgical Procedures, Previous, Complete Recovery
Item
Patient must be recovered from prior surgery
boolean
C0543467 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C2826210 (UMLS CUI [1,3])
Life Expectancy
Item
Patient must have a life expectancy >= 3 months.
boolean
C0023671 (UMLS CUI [1])
Laboratory Procedures
Item
Laboratory criteria: WBC >= 3000/mm3 Neutrophils >= 1,500/mm3 Platelet count >= 100,000/mm3 Serum creatinine <= 1,5mg/dL (133umol/L) or creatinine clearance > 60mL/min 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])
Item Group
Exclusion Criteria
C0680251 (UMLS CUI-1)
Primary tumor, Excision, Total
Item
Patient with primary tumor totally excised at time of diagnosis
boolean
C0677930 (UMLS CUI [1,1])
C0728940 (UMLS CUI [1,2])
C0439810 (UMLS CUI [1,3])
Rectal Carcinoma, Recurrent
Item
Patient with recurrent rectal cancer that failed initial treatment
boolean
C0007113 (UMLS CUI [1,1])
C2945760 (UMLS CUI [1,2])
Topotecan, Previous
Item
Patient previously treated with topotecan.
boolean
C0146224 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
Communicable Diseases, Active
Item
Patient with active infection.
boolean
C0009450 (UMLS CUI [1,1])
C0205177 (UMLS CUI [1,2])
Immunologic Deficiency Syndromes
Item
Any known primary or secondary immunodeficiencies.
boolean
C0021051 (UMLS CUI [1])
Gastrointestinal Diseases
Item
Any condition of the GI tract which would affect the GI absorption or motility (e.g. autonomic neuropathy, active gastric or duodenal ulcers or certain gastrointestinal surgeries). Patients receiving medication to maintain motility or gastric emptying are also excluded.
boolean
C0017178 (UMLS CUI [1])
Vomiting, Uncontrolled
Item
Patients with uncontrolled emesis, regardless of etiology.
boolean
C0042963 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
Malignant Neoplasms, Comorbidity; 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, carcinoma in situ of the cervix or Stage A low grade prostate cancer.
boolean
C0006826 (UMLS CUI [1,1])
C0009488 (UMLS CUI [1,2])
C0006826 (UMLS CUI [2,1])
C0205156 (UMLS CUI [2,2])
Comorbidity, Severe
Item
Concurrent severe medical problems unrelated to the malignancy which would significantly limit full compliance with the study or expose the patient to significant risk.
boolean
C0009488 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
Childbearing potential, Contraceptive methods
Item
Patient of child bearing potential, to practicing adequate conception (barrier method or IUD for three months before the start of the study and agree to continue for at least for 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])
Study Subject Participation Status
Item
Use of an investigational drug within 30 days or 5 half-lives (whichever is longer) preceding the first dose of study medication.
boolean
C2348568 (UMLS CUI [1])
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