Randomized Phase III Study of TS-1 Alone Versus TS-1 Plus CDDP in Advanced Gastric Cancer

July 6, 2011 updated by: Taiho Pharmaceutical Co., Ltd.
This study aimed to verify the survival benefit of TS-1 plus CDDP combination chemotherapy compared with the monotherapy by TS-1 alone.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a randomized, controlled, open-label, parallel, multicenter study. Patients are stratified according to 3 factors ; performance status (ECOG scale: 0, 1, 2), disease stage (unresectable gastric cancer or recurrent gastric cancer (received prior adjuvant chemotherapy or not)) and participating center. Patients are randomized to one of two treatment arms. Arm A: Patients receive oral TS-1 twice daily on days 1-28 followed by 14 days rest. Treatment is repeated every 42 days for up to 4 courses. Arm B: Patients receive CDDP iv on day 8 and oral TS-1 twice daily on days 1-21 followed by 14 days rest. Treatment is repeated every 35 days for up to 5 courses. Patients are followed every 6 months for up to 2 years from the day they participates in this study.

Study Type

Interventional

Enrollment

300

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
    • Kanagawa
      • 2-1-1, Asamizodai, Sagamihara, Kanagawa, Japan
        • East Hospital, Kitasato University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 74 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Histologically confirmed adenocarcinoma
  • Unresectable and recurrent gastric cancer
  • Age 20 to 74
  • Performance status 0, 1, or 2 (ECOG)
  • Life expectancy 3 months
  • No prior chemotherapy or radiotherapy for gastric cancer
  • Able to take oral medication
  • Evaluable or not evaluable lesion had already checked more than 28 days before participated in this study
  • Hematopoietic Absolute granulocyte count lower limit of normal-12,000/mm^3 Platelet ≥ 100,000/mm^3 Hemoglobin ≥ 8.0 g/dL
  • Hepatic AST and ALT ≤ 100 U/L ALP ≤ 2 times upper limit of normal (ULN) Bilirubin ≤ 1.5 mg/dL
  • Renal Plasma creatinine ≤ ULN Creatinine clearance ≥ 50 mL/min

Exclusion Criteria:

  • Pregnant or nursing
  • Bleeding from gastrointestinal tract or no diarrhea
  • Hypersensitivity to TS-1 or CDDP
  • Psychiatric disorder that would preclude study compliance or giving informed consent
  • Severe acute or chronic medical or psychiatric condition or laboratory abnormality
  • Serious illness or medical condition
  • Brain metastasis
  • Ascites requiring drainage

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
TS-1 and cisplatin
Drug: TS-1 and cisplatin
TS-1(40-60 mg per body surface area) was given orally, twice daily for 3 consecutive weeks, and 60 mg/m2 cisplatin was given intravenously on day 8, followed by a 2-week rest period, within a 5-week cycle.
Active Comparator: 2
TS-1
Drug: TS-1
TS-1(40-60 mg per body surface area) was given orally, twice daily for 4 consecutive weeks, followed by a 2-week rest period, within a 6-week cycle.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall survival
Time Frame: every course for first three courses, then every other course
every course for first three courses, then every other course

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall response rate, lesion-directed response rate, time to treatment failure (TTF), hospitalization-free survival period within the periods of TTF, and safety profile
Time Frame: every course for first three courses, then every other course
every course for first three courses, then every other course

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Taiho Pharmaceutical Co., Ltd.

Investigators

  • Principal Investigator: Wasaburo Koizumi, MD, PHD, East Hospital, Kitasato University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2002

Primary Completion (Actual)

December 1, 2006

Study Completion (Actual)

December 1, 2006

Study Registration Dates

First Submitted

September 7, 2005

First Submitted That Met QC Criteria

September 7, 2005

First Posted (Estimate)

September 8, 2005

Study Record Updates

Last Update Posted (Estimate)

July 7, 2011

Last Update Submitted That Met QC Criteria

July 6, 2011

Last Verified

July 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 91023039

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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