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 @ 2:09 PM
Ignite Modification Date:
2025-12-24 @ 2:09 PM
NCT ID:
NCT02002195
Eligibility Criteria:
Inclusion Criteria:
1. Elderly patients (aged ≥65 years)
2. Histologically or cytologically confirmed gastric adenocarcinoma, including gastric or gastroesophageal-junction adenocarcinoma (GEJ)
3. Eastern Cooperative Oncology Group (ECOG) performance status 0-2 (0-1 for patients aged ≥70 years, or with important comorbidity);
4. Measurable disease (revised RECIST) version 1.1. based on computed tomography
5. Adequate bone marrow, hepatic, and renal function, as evidenced by:
6. At least 4 weeks and recovery from effects of prior major surgery or radiation therapy
7. Ability to swallow an oral solid-dosage form of medication, including when a feeding tube is present
8. A negative serum pregnancy test within 7 days prior to accrual in women of childbearing potential (that is, all women except those who are post menopause for \> 1 year or who have a history of hysterectomy or surgical sterilization)
9. Agreement to use an effective form of contraception
10. Ability to comprehend and to comply with the requirements of the study
11. Estimated life expectancy ≥3 months
12. Adequate information and subsequent written informed consent
Exclusion Criteria:
1. Previous chemotherapy for metastatic/recurrent disease, except adjuvant chemotherapy completed at least 12 months before enrollment,
2. Previous treatment with oxaliplatin
3. Squamous cell gastric carcinoma
4. Bone-only metastatic disease significant gastrointestinal bleeding ,
5. Peripheral-neuropathy \> grade 2, History or presence of brain metastasis or leptomeningeal disease
6. Operable gastric or GEJ cancer
7. Herceptin (HER) 2 positive disease if the subject has not previously been treated with an anti -Herceptin (HER) 2 agent
8. Uncontrolled diarrhea, defined as more than 3 loose bowel movements above the subject's usual number of bowel movements on at least 3 days within the 14 days prior to study entry
9. Nausea or vomiting for at least 3 consecutive days within the 14 days prior to study entry despite the administration of standard antiemetic therapy
10. Known malabsorptive disorder
11. Second cancer (except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the subject has been disease-free for 5 or more years)
12. Human immunodeficiency virus infection based on history of positive serology
13. Significant medical disease other than gastric cancer, including but not limited to uncontrolled diabetes mellitus, active angina or heart failure, uncontrolled hypertension, or an active psychiatric condition that would prevent consistent and compliant participation in the study
14. Presence of neuropathy \> Grade 1
15. Prior radiation therapy to more than 25% of the bone marrow
16. Need for other anticancer treatment (such as chemotherapy, radiation therapy, or biologic therapy with an approved or investigational agent) while receiving protocol therapy
17. History of severe or unexpected reaction to fluoropyrimidine therapy
18. History of hypersensitivity to fluoropyrimidine agents or any of their ingredients.
19. Known dihydropyrimidine dehydrogenase deficiency
20. Pregnancy or lactation
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
65 Years
Maximum Age:
99 Years
Study:
NCT02002195
Study Brief:
Protocol Section:
NCT02002195