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:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2025-12-25 @ 2:16 AM
NCT ID:
NCT00011960
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed stage IB-IIIB adenocarcinoma of the stomach or gastroesophageal junction having undergone potentially curative resection of primary tumor
* No more than 8 weeks since primary tumor resection
* No metastatic disease
PATIENT CHARACTERISTICS:
Age:
* Not specified
Performance status:
* Zubrod 0-1
Life expectancy:
* Not specified
Hematopoietic:
* WBC (white blood cell count) at least 4,000/mm\^3
* Platelet count at least 150,000/mm\^3
Hepatic:
* Bilirubin no greater than 1.5 mg/dL
* AST (aspartate aminotransferase) and ALT (alanine amino transferase) no greater than 2.5 times upper limit of normal
Renal:
* BUN(blood urea nitrogen)less than 30 mg/dL
* Creatinine no greater than 1.4 mg/dL
* Creatinine clearance greater than 50 mL/min
Cardiovascular:
* No New York Heart Association class III or IV heart disease
* No active angina or myocardial infarction within the past 6 months
* No history of significant ventricular arrhythmia requiring medication with antiarrhythmics
* No history of clinically significant conduction system abnormality
Other:
* No concurrent serious infection that is uncontrolled or would preclude study participation
* No nonmalignant medical illness that is uncontrolled or would preclude study participation
* No psychiatric disorders that would preclude study participation
* No other active malignancy within the past 3 years except nonmelanoma skin cancer or carcinoma in situ of the cervix
* No clinically significant hearing loss
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* Not specified
Chemotherapy:
* No prior chemotherapy
* No other concurrent chemotherapy
Endocrine therapy:
* Not specified
Radiotherapy:
* No prior radiotherapy to the treatment field
Surgery:
* See Disease Characteristics
Other:
* No other concurrent anticancer therapy
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT00011960
Study Brief:
Protocol Section:
NCT00011960