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 @ 1:35 AM
Ignite Modification Date:
2025-12-25 @ 1:35 AM
NCT ID:
NCT01412294
Eligibility Criteria:
Inclusion Criteria:
1. Recurrent gastric cancer histologically confirmed as being adenocarcinoma
2. Age of 20 to 74 years with either gender
3. ECOG Performance Status of 0 to 2
4. Lesions confirmed on imaging within 28 days before registration (not required measurable lesions as defined in RECIST version 1.1)
5. Post-gastrectomy adjuvant chemotherapy including S-1 for at least 12 weeks including interruption period
6. Less than 6 months treatment-free interval from completion of adjuvant therapy
7. In case with receiving neoadjuvant chemotherapy, the total dose of CDDP does not exceed 120mg/m2
8. Treatment-naïve recurrent gastric cancer
9. Life expectancy of at least 3 months after registration
10. Written informed consent
11. Adequate major organ functions within 14 days before registration
Exclusion Criteria:
12. Positive HER2 status
13. Previous treatment with platinum agents after curative surgery
14. Previous history of serious hypersensitivity to fluoropyrimidines or platinum agents
15. Previous history of adverse reactions suggestive of dihydropyrimidine dehydrogenase (DPD) deficiency
16. More than one cancer at the same time or more than one cancer at different times separated by a 5-year disease-free interval. However, multiple active cancers do not include carcinoma in situ or skin cancer which is determined to have been cured as a result of treatment.
17. Obvious infection or inflammation (pyrexia ≥ 38.0˚C)
18. Active hepatitis
19. Heart disease that is serious or requires hospitalization, or history of such disease within past year
9\) Concurrent illness that is serious or requires hospitalization (intestinal paralysis, intestinal obstruction, interstitial pneumonia or pulmonary fibrosis, poorly controlled diabetes mellitus, renal failure, liver disorders, or hepatic cirrhosis)
10\) Being treated or in need of treatment with phenytoin or warfarin potassium
11\) Chronic diarrhea (watery stool or ≥ 4 times/day)
12\) Active gastrointestinal hemorrhage
13\) Body cavity fluids requiring drainage or other treatment
14\) Clinical suspicion or previous history of metastases to brain or meninges
15\) Women who are pregnant, breastfeeding, or potentially (hoping to become) pregnant 16) Unwillingness to practice contraception
17\) Poor oral intake
18\) Psychiatric disorders which are being or may need to be treated with psychotropics
19\) Otherwise determined by investigators or site principal investigators to be unsuitable for participation in study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Weeks
Maximum Age:
74 Years
Study:
NCT01412294
Study Brief:
Protocol Section:
NCT01412294