Phase II study of TS-1+Trastuzumab in HER2-positive advanced gastric cancer patients more than 65 years old

Phase 2

• Conditions: HER2-positive advanced gastric cancer

• Registration Number: JPRN-UMIN000007368
• Lead Sponsor: Japna Clinical Cancer Research Organizetion

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-02-23
• Study Completion: 2016-02-01
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

Exclusion Criteria

1) Scond primary malignancy (except adequately treated basal cell carcinoma treated more than 5 years ago without recurrence) 2) Severe ascites and / or pleural effusion 3) Patients with brain metastasis 4) Patients with fresh bleeding from gastric cancer and / or the digestive tract 5) Patients with active infection (> 38C) 6) Patients have active hepatitis type B 7) Patients with a previous history of congestive heart failure 8) Unstable angina requiring medication 9) Patients with a previous history of transmural infarct 10) Uncontrolled hypertension 11) Severe heart valve diseases 12) Hi-risk uncontrolled arrhythmias 13) Serious complication as followings; interstitial pneumonia; pulmonary fibrosis; heartfailure; renal failure; hepatic failure; uncontrolled diabetes mellitus 14) Patients with resting dyspnea 15) Patients with diarrhea (4 or more times per day or watery diarrhea) 16) Patients who are contraindicated to TS-1 and Trastuzumab 17) Hypersensitivity to have a history TS-1 and / or Trastuzumab 18) Patients who are received systemic continuous admnistration of flucytosine. 19) Patients who are recieving systemic continuous administration of phenytoin or warfarin 20) Patients who are received systemic administration of corticosteroid for a long time or with high doses 21) Women in pregnancy, at risk of pregnancy, or hoping to become pregnant. Men who want their partners to become pregnant. 22) Any patinets judged by the investigator to be unfit to perticipate in the study

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Response rate (RR)

Secondary Outcome Measures

Name	Time	Method
Overall survival(OS) Progression free survaval(PFS) Time to treatment faulure(TTF) Safety