A randomized phase l study on TS-1+CDDP+CPT-11(IPS) therapy for patients with advanced/metastatic gastric cancer(HERBIS-4A) (OGSG 1106)

Phase 1

• Conditions: Gastric Cancer

• Registration Number: JPRN-UMIN000006864
• Lead Sponsor: Osaka Gastroestinal cancer chemotherapy Study Group (OGSG)

Brief Summary

With reference to the number of grade 4 or higher adverse event occurrences, the recommended doses were determined to be irinotecan 100 mg/m2, cisplatin 60 mg/m2, and S-1 80 mg/m2; the maximum tolerated doses were irinotecan 125 mg/m2, cisplatin 60 mg/m2, and S-1 80 mg/m2.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-12-10
• Study Completion: 2018-02-13
• Results First Posted: 2023-07-07
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

Not provided

Exclusion Criteria

1)with active double cancers whose disease free period is shorter than 5 years Carcinoma in situ can be included 2)with a history of severe allergy against medicines 3)with severe diarrhea (more than 4 times/day) or watery stool 4)with body temperature over 38 degrees Celsius and/or infectious disease which needs therapy 5)with severe myelo-dysfunction, renal dysfunction and/or liver dysfunction 6)with other sever diseases a)interstitial pneumonitis, pulmonary fibrosis or severe emphysema b)cardiac failure, cardiac infarction, angina pectoris c)renal dysfunction d)liver dysfunction e)intestinal paralysis, ileus f)jaundice g)uncontrolled DM 7)with HBs (+) 8)patients whom administered Flucitosine or Athazanavil sulfate 9)patients whom administered Fenitoin and/or Warfarin 10)general administration of steroids 11)women who are pregnant or expect to be pregnant, or nursing female 12)patients whom doctor in chief decides not to register to this study due to psychological disease or symptoms 13)patients whom doctor in chief decides not to register to this study due to other reasons

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
maximum tolerated dose and recommended dose

Secondary Outcome Measures

Name	Time	Method
Response Rate (RR) Incidence of adverse events