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 @ 4:07 AM
Ignite Modification Date:
2025-12-25 @ 4:07 AM
NCT ID:
NCT00514020
Eligibility Criteria:
Inclusion Criteria:
* Patients must have histologically or cytologically confirmed adenocarcinoma of the stomach or gastroesophageal junction
* Metastatic disease
* Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as ≥ 20 mm with conventional techniques or as ≥ 10 mm with spiral CT scan
* No known active brain metastases
* Patients with treated brain metastases are eligible if stable off steroids for at least 30 days
PATIENT CHARACTERISTICS:
* ECOG performance status ≤ 2 (Karnofsky performance status ≥ 60%)
* Life expectancy ≥ 3 months
* WBC ≥ 3,000/μL
* Absolute neutrophil count ≥ 1,500/μL
* Platelets ≥ 100,000/μL
* Total bilirubin ≤ 1.5 x upper limit of normal (ULN)
* AST or ALT ≤ 2.5 x ULN (\< 5 x ULN if known liver metastases)
* Creatinine clearance ≤ 1.5 x ULN
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for 21 days after completion of study treatment
* No history of allergic reactions to fluorouracil or oxaliplatin
* No concurrent uncontrolled illness including, but not limited to, ongoing or active infection or psychiatric illness/social situations that would limit compliance with study requirements
PRIOR CONCURRENT THERAPY:
* No prior therapy for metastatic disease
* Prior neoadjuvant or adjuvant therapy is allowed if the disease-free interval has been longer than 6 months
* No other concurrent chemotherapy
* No concurrent combination anti-retroviral therapy for HIV-positive patients
* No concurrent routine prophylaxis with filgrastim (G-CSF)
* No other concurrent antineoplastic agents, including chemotherapy, radiation therapy, or biologic agents
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00514020
Study Brief:
Protocol Section:
NCT00514020