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 @ 7:36 PM
Ignite Modification Date:
2025-12-24 @ 7:36 PM
NCT ID:
NCT00004103
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically proven, previously untreated gastric cancer
* Stage IB, II, III, or IV (T3-4, N0 OR any T, N1-2, M0)
* No metastases
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Performance status:
* SWOG 0-2
Life expectancy:
* Not specified
Hematopoietic:
* WBC at least 4000/mm\^3
* Platelet count at least 100,000/mm\^3
* Hemoglobin at least 9 g/dL
Hepatic:
* Bilirubin less than 2 mg/dL
* SGOT/SGPT no greater than 2 times upper limit of normal (ULN)
* Alkaline phosphatase no greater than 3 times ULN
* PT, aPTT, and TT normal
* No Gilbert's disease
Renal:
* BUN no greater than 30 mg/dL
* Creatinine no greater than 1.5 mg/dL OR
* Creatinine clearance greater than 60 mL/min
Cardiovascular:
* No myocardial infarction within the past 3 months
* No congestive heart failure requiring therapy
Other:
* No other invasive malignancy in the past 5 years except adequately treated basal or squamous cell skin cancer or carcinoma in situ of the cervix
* No active or uncontrolled infection
* HIV negative
* No other severe concurrent disease
* No psychiatric disorders that would preclude compliance
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* Not specified
Chemotherapy:
* No prior chemotherapy for gastric cancer
Endocrine therapy:
* Not specified
Radiotherapy:
* No prior radiotherapy for gastric cancer
Surgery:
* No prior surgery for gastric cancer
* No emergent need for surgery for gastrointestinal obstruction, perforation, or hemorrhage
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00004103
Study Brief:
Protocol Section:
NCT00004103