Capecitabine / Cisplatin / Trastuzumab for previously untreated HER2 positive advanced gastric cancer. -Phase II study

Phase 2

Recruiting

• Conditions: untreated HER2 positive advanced gastric cancer

• Registration Number: JPRN-UMIN000006591
• Lead Sponsor: SGCSG: Shimane Gastroenterological Cancer Study Group

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-10-22
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

Not provided

Exclusion Criteria

(1) Forbidden case to use capecitabine, Cisplatin and Trastuzumab. (2) R1 operation(histlogically positive PM, OM, LM, VM). (3) Infection or inflammatory case. (4) Severe heart disease. (5) Severe complicated case such as ileus, interstitial pneumonia, uncontrolled DM, liver cirrhosis etc. (6) Severe ascites and/or pleural effusion. (7) Multiple bone metastasis. (8) Clinical suspicion or previous history of metastasis to brain or meninges. (9) Difficulty to join the trial due to psychosis or psychotic symptoms or central nervous system damage. (10)Complicated other active cancer. (11)patient who want to be pregnant and /or pregnant woman. (12)Intend to make pregnant. (13)Active hepatitis type HBs positive. (14)Otherwise determined by investigators or site principal investigators to be unsuitable for participation in study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
PFS: Progression Free Survival

Secondary Outcome Measures

Name	Time	Method
ORR:Overall Response Rate DCR:Disease Control Rate OS:Overall Survival Safety