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.

Tracking Information

• First Submitted Date: September 7, 2005
• First Posted Date: September 8, 2005
• Last Update Posted Date: July 7, 2011
• Study Start Date: March 2002
• Actual Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: July 31, 2008): Overall survival [ Time Frame: every course for first three courses, then every other course ]
• Original Primary Outcome Measures (submitted: September 7, 2005): Overall survival
• Current Secondary Outcome Measures (submitted: July 31, 2008): 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 ]
• Original Secondary Outcome Measures (submitted: September 7, 2005): Overall response rate, lesion-directed response rate, time to treatment failure (TTF), hospitalization-free survival period within the periods of TTF, and safety profile
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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.
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Gastric Cancer

Intervention

• 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.
• 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.

Study Arms

• Experimental: 1
  TS-1 and cisplatin
  Intervention: Drug: TS-1 and cisplatin
• Active Comparator: 2
  TS-1
  Intervention: Drug: TS-1

• Publications *: 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.

Recruitment Information

• Recruitment Status: Completed
• Enrollment (submitted: September 7, 2005): 300
• Original Enrollment: Same as current
• Actual Study Completion Date: December 2006
• Actual Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 20 Years to 74 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Japan

Administrative Information

• NCT Number: NCT00150670
• Other Study ID Numbers: 91023039
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Taiho Pharmaceutical Co., Ltd.
• Original Responsible Party: Not Provided
• Current Study Sponsor: Taiho Pharmaceutical Co., Ltd.
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

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

• PRS Account: Taiho Pharmaceutical Co., Ltd.
• Verification Date: July 2011