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:
NCT00005060
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed locally advanced gastric carcinoma that is considered operable
* T3-4, Nx, M0 OR
* Tx, N+, M0
* Lymph nodes considered positive by sonography should be at least 2 of the following:
* Round
* Echopoor
* Sharp borders
* At least 0.5 cm
* No distant metastases, including peritoneal carcinomatosis
* CT scan and peritoneal lavage mandatory
PATIENT CHARACTERISTICS:
Age:
* 18 to 75
Performance status:
* 0-2
Life expectancy:
* Greater than 12 weeks
Hematopoietic:
* WBC at least 4,000/mm\^3
* Platelet count at least 100,000/mm\^3
Hepatic:
* Bilirubin normal
* AST or ALT no greater than 1.5 times upper limit of normal (ULN)
* Alkaline phosphatase no greater than 2.5 times ULN
Renal:
* Adequate renal function within limits to allow for treatment with cisplatin
Cardiovascular:
* No unstable cardiac disease requiring treatment
* No congestive heart failure or angina pectoris even if medically controlled
* No significant arrhythmias
* No myocardial infarction within past 6 months
* Ejection fraction greater than 50% on cardiac sonography or MUGA scan
Other:
* Not pregnant or nursing
* Fertile patients must use effective contraception
* No other prior malignancy except basal cell carcinoma of the skin or adequately treated carcinoma in situ of the cervix
* No grade 2 or greater peripheral neuropathy of any origin (e.g., alcohol, diabetic)
* No history of anaphylaxis
* No other serious concurrent illness or medical condition that would preclude study therapy
* No history of significant neurologic or psychiatric disorders (e.g., psychotic disorders, dementia, or seizures)
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* No concurrent biologic therapy for gastric carcinoma
Chemotherapy:
* No other concurrent chemotherapy for gastric carcinoma
Endocrine therapy:
* No concurrent endocrine therapy for gastric carcinoma
Radiotherapy:
* No concurrent radiotherapy for gastric carcinoma
Surgery:
* See Disease Characteristics
Other:
* At least 30 days since prior treatment in a clinical trial
* No other concurrent experimental drugs
* No other concurrent anticancer therapy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT00005060
Study Brief:
Protocol Section:
NCT00005060