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 @ 2:49 AM
Ignite Modification Date:
2025-12-25 @ 2:49 AM
NCT ID:
NCT00533533
Eligibility Criteria:
Inclusion Criteria:
* Histologically documented gastric adenocarcinoma including adenocarcinoma of the esophagogastric junction
* 18 ≤ age ≤ 70
* ECOG performance status of 0 - 2
* At least one definite measurable lesion(s): ≥ 1 cm on spiral CT scan or ≥ 2 cm in physical examination
* Previously untreated metastatic gastric cancer patients or relapsed gastric cancer patients (patients with recurrence at least 6 months from the date of last administration of adjuvant chemotherapy and/or radiation therapy with 5-FU and/or leucovorin containing regimen will be included in the study)
* Written informed consent
* Minimum life expectancy of 12 weeks
* Adequate liver, renal, bone marrow functions as evidence by the following; Absolute neutrophil count \> 1.5 x 109/L; platelets \> 100 x 109/L; ASAT and/or ALAT \< 3 UNL; serum creatinine ≤ 1.5 ULN
Exclusion Criteria:
* Any other malignancies within the past 5 years except skin basal cell cancer or CIS of cervix
* Serious comorbid diseases
* Pregnancy or lactation
* Previous history of drug allergy to one of the drugs in the study regimen
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT00533533
Study Brief:
Protocol Section:
NCT00533533