S-1/trastuzumab for elderly HER2 positive advanced gastric cancer-Pilot study

Not Applicable

• Conditions: untreated HER2 positive advanced gastric cancer

• Registration Number: JPRN-UMIN000006757
• Lead Sponsor: Digestive Desease Support Organization

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-11-22
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Not provided

Exclusion Criteria

1) Forbidden case to use S-1 and Trastuzumab 2) Infection or inflammatory case 3) Cardiovascular disease (congestive heart failure, Myocardial infarction, Ischemic heart disease, vulver disease) 4) Severe complicated case such as ileus, interstitial pneumonia, uncontrolled DM, liver cirrhosis etc. 5) Severe ascites and/or pleural effusion 6) Multiple bone metastasis 7) Clinical suspicion or previous history of metastasis to brain or meninges 8) Active digestive bleeding required repeat blood transfusion 9) severe diarrhea (4 times over /day) 10) Difficulty to join the trial due to psychosis or psychotic symptoms or central nervous system damage 11) Complicated other active cancer 12) patient who want to be pregnant and /or pregnant woman 13) Intend to make pregnant 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
frequency and degree of adversed events

Secondary Outcome Measures

Name	Time	Method
Overall survival, Progression free survival, Overall response rate