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

Primary Purpose

Gastric Cancer

Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
TS-1 and cisplatin
TS-1
Sponsored by
Taiho Pharmaceutical Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastric Cancer focused on measuring Stomach cancer

Eligibility Criteria

20 Years - 74 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • East Hospital, Kitasato University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

TS-1 and cisplatin

TS-1

Outcomes

Primary Outcome Measures

Overall survival

Secondary Outcome Measures

Overall response rate, lesion-directed response rate, time to treatment failure (TTF), hospitalization-free survival period within the periods of TTF, and safety profile

Full Information

First Posted
September 7, 2005
Last Updated
July 6, 2011
Sponsor
Taiho Pharmaceutical Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT00150670
Brief Title
Randomized Phase III Study of TS-1 Alone Versus TS-1 Plus CDDP in Advanced Gastric Cancer
Official Title
Randomized Phase III Study of TS-1 Alone Versus TS-1 Plus CDDP in Advanced Gastric Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
July 2011
Overall Recruitment Status
Completed
Study Start Date
March 2002 (undefined)
Primary Completion Date
December 2006 (Actual)
Study Completion Date
December 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Taiho Pharmaceutical Co., Ltd.

4. Oversight

5. Study Description

Brief Summary
This study aimed to verify the survival benefit of TS-1 plus CDDP combination chemotherapy compared with the monotherapy by TS-1 alone.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer
Keywords
Stomach cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (false)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
TS-1 and cisplatin
Arm Title
2
Arm Type
Active Comparator
Arm Description
TS-1
Intervention Type
Drug
Intervention Name(s)
TS-1 and cisplatin
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
TS-1
Intervention Description
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.
Primary Outcome Measure Information:
Title
Overall survival
Time Frame
every course for first three courses, then every other course
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wasaburo Koizumi, MD, PHD
Organizational Affiliation
East Hospital, Kitasato University
Official's Role
Principal Investigator
Facility Information:
Facility Name
East Hospital, Kitasato University
City
2-1-1, Asamizodai, Sagamihara
State/Province
Kanagawa
Country
Japan

12. IPD Sharing Statement

Citations:
PubMed Identifier
18282805
Citation
Koizumi W, Narahara H, Hara T, Takagane A, Akiya T, Takagi M, Miyashita K, Nishizaki T, Kobayashi O, Takiyama W, Toh Y, Nagaie T, Takagi S, Yamamura Y, Yanaoka K, Orita H, Takeuchi M. S-1 plus cisplatin versus S-1 alone for first-line treatment of advanced gastric cancer (SPIRITS trial): a phase III trial. Lancet Oncol. 2008 Mar;9(3):215-21. doi: 10.1016/S1470-2045(08)70035-4. Epub 2008 Feb 20.
Results Reference
result

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

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