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 @ 7:34 PM
Ignite Modification Date:
2025-12-24 @ 7:34 PM
NCT ID:
NCT00980603
Eligibility Criteria:
Inclusion Criteria:
* Histologically or cytologically confirmed gastric adenocarcinoma with metastatic disease
* Age ≥18 years
* Eastern Cooperative Oncology Group performance status 0-2
* At least one measurable lesion as defined by RECIST
* Only one prior chemotherapy containing both S-1 or capecitabine and cisplatin for metastatic gastric cancer with documented progression of disease occurring during chemotherapy or within 6 months of completion of chemotherapy
* Adequate major organ function:
ANC ≥1,500/mm3, Platelet ≥100,000/mm3, serum bilirubin ≤1.5 x upper limit of normal (ULN), AST/ALT ≤2.5 x ULN (≤5 x ULN if liver metastases are present), creatinine clearance ≥50 ml/min using the calculation formula or 24 hours urine collection
* Patients should sign a written informed consent before study entry
Exclusion Criteria:
* Prior taxane treatment
* Major surgery or radiotherapy less than 4 weeks prior to entry
* NCI CTCAE (version 3.0) adverse events ≥grade 2 except alopecia, fatigue, and weight loss
* Lack of physical integrity of the upper gastrointestinal tract or malabsorption syndrome, or inability to take oral medication
* Patients with active gastrointestinal bleeding
* Inadequate cardiovascular function
* Serious concurrent infection or nonmalignant illness that is uncontrolled or whose control may be jeopardized by complications of study therapy
* Other malignancy within the past 3 years except adequately treated non-melanomatous skin cancer, carcinoma in situ of the cervix, or in situ of prostate cancer Gleason≤7
* Psychiatric disorder that would preclude compliance
* Patients receiving a concomitant treatment with drugs interacting with S-1 such as flucytosine, phenytoin, or allopurinol
* Female patients who are pregnant or breast feeding or adults of reproductive potential not employing effective method of birth control
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00980603
Study Brief:
Protocol Section:
NCT00980603