A phase II study on TS-1 treatment for aged patients (<=75 years old) with advanced and/or recurrent gastric cancer (OGSG 0404)

Not Applicable

• Conditions: advanced and/or recurrent gastric cancer

• Registration Number: JPRN-UMIN000000661
• Lead Sponsor: Osaka Gastrointestinal Cancer Chemotherapy Study Group (OGSG)

Brief Summary

The response rate (RR) was 14.3% and the median overall survival was 14.6 months.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-04-05
• Study Completion: 2010-06-01
• Results First Posted: 2013-02-06
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

Not provided

Exclusion Criteria

1. with active double cancer 2. with severe other diseases(intestinal paralysis, ileus, intersitial pneumonitis or plumonary fibrosis, uncontrolled DM, cardiac failure, renal dysfunction, liver dysfunction, respiratory dysfunction) 3. severe ascites and/or pulmonary fluid 4. metastasis on central nerve system with symptom 5. fresh bleeding on digestive tract 6. with severe ischemic cardiac disease which needs treatment 7. hypersensitive response to TS-1 8. with severe bone marrow supplession, renal dysfunction or liver dysfunction 9. under administration of flucytosine 10. patients who underwent postoperative adjuvant chemotherapy of TS-1 11. doctor's exclusion due to some reason

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Aanti-cancer effects (Response Rate, Response Period)

Secondary Outcome Measures

Name	Time	Method
Feasibility (Incidence of Adverse Events), Overall Survival, Progression Free Survival, Time to Treatment Failure, Relationship to the score of MMSE