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

• ClinicalTrials.gov Identifier: NCT00150670
• Recruitment Status: Completed
• First Posted: September 8, 2005
• Last Update Posted: July 7, 2011
• Sponsor: Taiho Pharmaceutical Co., Ltd.
• Information provided by: Taiho Pharmaceutical Co., Ltd.

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.

Condition or disease	Intervention/treatment	Phase
Gastric Cancer	Drug: TS-1 and cisplatin; Drug: TS-1	Phase 3

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 Design

• Study Type: Interventional (Clinical Trial)
• Enrollment: 300 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Randomized Phase III Study of TS-1 Alone Versus TS-1 Plus CDDP in Advanced Gastric Cancer
• Study Start Date: March 2002
• Actual Primary Completion Date: December 2006
• Actual Study Completion Date: December 2006

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. Overall survival [ Time Frame: every course for first three courses, then every other course ]

Secondary Outcome Measures :

1. 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 ]

Eligibility Criteria

• Ages Eligible for Study: 20 Years to 74 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

Japan

East Hospital, Kitasato University

2-1-1, Asamizodai, Sagamihara, Kanagawa, Japan

Sponsors and Collaborators

Taiho Pharmaceutical Co., Ltd.

Investigators

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

More Information

Publications of Results:

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.

• Responsible Party: Taiho Pharmaceutical Co., Ltd.
• ClinicalTrials.gov Identifier: NCT00150670
• Other Study ID Numbers: 91023039
• First Posted: September 8, 2005
• Last Update Posted: July 7, 2011
• Last Verified: July 2011

Keywords provided by Taiho Pharmaceutical Co., Ltd.:

Stomach cancer

Additional relevant MeSH terms:

Stomach Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Cisplatin; Antineoplastic Agents