Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:34 PM
Ignite Modification Date:
2025-12-24 @ 5:34 PM
NCT ID:
NCT00220168
Eligibility Criteria:
Inclusion Criteria:
* Histologically proven adenocarcinoma or squamous cell carcinoma of oesophagus, O-G junction and stomach, not amenable to surgical resection.
* Bidimensionally measurable disease, or unidimensional measurable disease assessable by CT scanning, not within previously irradiated areas.
* Patients with progressive disease during previous chemotherapy treatment or within three months of stopping treatment.
* At least one previous chemotherapy regimen, given within 3 months prior to inclusion in this study.
* No previous exposure to irinotecan.
* Adequate bone marrow function with platelets \>100 X 109/L; WBC \> 3 X 109/L; Neutrophils \> 1.5 X 109/L at the time of study entry.
* Satisfactory renal function. Creatinine clearance (measured by Cockcroft and Gault) \>50ml/min and Cr \<135.
* Satisfactory liver function:
* In the absence of liver metastases: Bilirubin \< 1.25N (N=upper limit of normal range) Hepatic transaminases \< 2.5N Prothrombin time \< 1.5N
* In the presence of liver metastases: Bilirubin \< 1.5N Hepatic transaminases \< 5N Prothrombin time \< 1.5N
* No uncontrolled medical condition
* No previous malignant disease except for non-melanotic skin cancer or in-situ carcinoma of the uterine cervix.
* ECOG performance status of 0, 1 or 2.
* Predicted life expectancy of \> 3 months.
* Adequate contraceptive precautions
* Informed written consent
Exclusion Criteria:
* Medical or psychiatric conditions resulting in inability of patient to give written consent.
* ECOG Performance status \>2
* Intracerebral metastases or meningeal carcinomatosis
* Unresolved bowel obstruction
* Creatinine clearance \<50ml/min, Cr \>135
* Uncontrolled angina pectoris, heart failure (New York heart classification 3 or 4).
* Pregnancy/lactation
* Previous malignancy other than adequately treated basal cell carcinoma of the skin or cervical carcinoma in situ.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00220168
Study Brief:
Protocol Section:
NCT00220168