A phase II study of preoperative TS-1+CDDP+DTX therapy for large type 3 or type 4 gastric cancer (OGSG 1402)

Phase 2

• Conditions: large type 3 or type 4 gastric cancer

• Registration Number: JPRN-UMIN000015631
• Lead Sponsor: Osaka Gastrointestinal cancer chemotherapy Study Group (OGSG)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-11-10
• Study Completion: 2021-06-24
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

Not provided

Exclusion Criteria

1)with active double cancers excluding carcinoma in situ and/or prior cancer cured with longer than 5 year interval period 2)with a history of severe allergic reaction against medicines 3)with active infectious diseases (over 38 centigrade of body temperature) 4)pregnant or nursing female 5)male expecting pregnancy of partner 6)with a history of cardiac infarction within 6 months 7)under continuous steroids medication 8)under continuous medication of phenytoin or warfarin 9)with uncontrollable diarrhea (frequent movement and/or watery stool) 10)with HBs antigen positive or HCV antibody positive 11)With severe diseases (collagen disease, intestinal paralysis, interstitial pneumonitis, and/or ischemic cardiac disease) 12)Any other patients whom the physician in charge of the study judges to be unsuitable

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
incidence of curative resection (R0 ratio)

Secondary Outcome Measures

Name	Time	Method
Preoperative treatment completion rate Postoperative treatment completion rate Disease Free Survival Overall Survival (OS) Response Rate of preoperative chemotherapy (RECIST v 1.1) Histological Response Rate of preoperative Chemotherapy AE rate of preoperative chemotherapy Incidence of postoperative adverse events