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
Temperature
text
C0886414 (UMLS CUI [1,1])
C0449444 (UMLS CUI [1,2])
Item
Temperature
text
C0005903 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])
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])
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])
Code List
Record the date of the last recurrence or mark the N/A box if no remission obtained.
CL Item
Not Applicable (1)
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])
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])
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])
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])
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])
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])
CL Item
Normal/no clinically significant abnormality (1)
CL Item
Clinically significant abnormality (2)
Item
Diagnostic Procedure
text
C0430022 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
C0430022 (UMLS CUI [1,3])
Code List
Diagnostic Procedure
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])
CL Item
Normal/ no clinically significant abnormality (1)
CL Item
Clinically significant abnormality (2)
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])
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])
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])
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])
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])
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])
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)