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 @ 12:36 AM
Ignite Modification Date:
2025-12-25 @ 12:36 AM
NCT ID:
NCT00447967
Eligibility Criteria:
Inclusion Criteria:
* Histologically confirmed locally advanced or metastatic gastric cancer.
* Measurable or evaluable disease.
* Measurable disease is defined as at least 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques or 1 bidimensionally measurable lesion ≥ 20 X 10 mm. Lesions that are smaller or uni- or bidimensionally unmeasurable are considered as evaluable disease.
* Previous adjuvant chemotherapy with Irinotecan, Oxaliplatin and/or 5-FU based regimen. Patients who relapse within the first 6 months after the completion of adjuvant treatment are not eligible for the study.
* Karnofsky performance status \> 70%.
* Age ≥18 years.
* Adequate liver (Bilirubin ≤ 1.5 UNL, SGOT/SGPT ≤ 4 UNL, ALP ≤ 2.5 UNL), renal (Creatinine ≤ 1.5 UNL) and bone marrow (ANC ≥ 1,500/mm3, PLT ≥ 100,000/mm3) function.
* Patients must be able to understand the nature of this study and give written informed consent.
Exclusion Criteria:
* Active infection
* History of serious cardiac disease (unstable angina, congestive heart failure, myocardial infarction within the previous 6 months, ventricular arrhythmias)
* Previous radiotherapy within the last 4 weeks or \> 25% of bone marrow.
* Patients with CNS metastases
* Patients with chronic diarrhea (at least for 3 months) or partial bowel obstruction.
* Malnutrition or loss of \> 10% of body weight during the last month.
* Peripheral neuropathy ≥ grade 2
* Second primary malignancy, except for non-melanoma skin cancer and in situ cervical cancer.
* Psychiatric illness or social situation that would preclude study compliance.
* Pregnant or lactating women.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT00447967
Study Brief:
Protocol Section:
NCT00447967