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
Height - Unit
text
C0005890 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])
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
Item
Weight
float
C0005910 (UMLS CUI [1])
Item
Temperature - Measurement Site
text
C0489453 (UMLS CUI [1])
Code List
Temperature - Measurement Site
Item
Temperature - Unit
text
C0005903 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])
Code List
Temperature - Unit
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])
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])
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])
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])
CL Item
Normal/No clinically significant abnormality (1)
CL Item
Clinically significant abnormality (2)
Item
Diagnostic Procedure
text
C0007113 (UMLS CUI [1,1])
C0220825 (UMLS CUI [1,2])
C0430022 (UMLS CUI [1,3])
Code List
Diagnostic Procedure
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)
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])
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])
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])
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])
Code List
Past or Current/Active?
CL Item
Current/Active (2)
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])
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])
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])