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 @ 2:53 PM
Ignite Modification Date:
2025-12-24 @ 2:53 PM
NCT ID:
NCT00335959
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed primary adenocarcinoma of the stomach, meeting the following criteria:
* Newly diagnosed disease amenable to curative resection
* Stage IB-III (T2-4)
* Measurable or nonmeasurable disease
* Enlarged lymph nodes outside of radiation fields must have preoperative biopsies
* No positive lymph nodes outside of radiation fields
* No distant metastasis
* No gastroesophageal junction tumors
PATIENT CHARACTERISTICS:
* Zubrod performance status 0-1
* Absolute neutrophil count ≥ 1,500/mm³
* WBC ≥ 3,000/mm³
* Platelet count ≥ 100,000/mm³
* Creatinine ≤ 1.5 times upper limit of normal
* Albumin ≥ 3 g/dL
* Bilirubin normal
* No evidence of ischemic heart disease by EKG
* No coronary artery disease requiring active medical treatment
* No symptoms of angina
* No history of myocardial infarction
* No deep vein thrombosis within the past 12 months
* No pre-existing peripheral neuropathy
* No active pneumonia or inflammatory lung infiltrate
* No prior malignancy except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease free for ≥ 5 years
* No clinically significant comorbid medical conditions that would prevent delivery of chemotherapy, radiotherapy, or the performance of surgery
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
* At least 4 weeks since prior and no concurrent sorivudine or brivudine
* No prior therapy for this malignancy, including chemotherapy, surgery, immunotherapy, or radiotherapy
* No prior coronary angioplasty or stenting
* No concurrent 2-dimensional or intensity-modulated radiotherapy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00335959
Study Brief:
Protocol Section:
NCT00335959