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

Sponsored by:	Taiho Pharmaceutical Co., Ltd.
Information provided by:	Taiho Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:	NCT00150670

Purpose

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

Condition	Intervention	Phase
Gastric Cancer	Drug: TS-1 and cisplatin Drug: TS-1	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Randomized Phase III Study of TS-1 Alone Versus TS-1 Plus CDDP in Advanced Gastric Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer Stomach Cancer

Drug Information available for: Cisplatin S 1 (Combination)

U.S. FDA Resources

Further study details as provided by Taiho Pharmaceutical Co., Ltd.:

Primary Outcome Measures:

Overall survival [ Time Frame: every course for first three courses, then every other course ] [ Designated as safety issue: No ]

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 [ Time Frame: every course for first three courses, then every other course ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	300
Study Start Date:	March 2002
Study Completion Date:	December 2006
Primary Completion Date:	December 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 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.
2: Active Comparator 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.

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.

Eligibility

Ages Eligible for Study:	20 Years to 74 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00150670

Locations

Japan, Kanagawa
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:

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. Epub 2008 Feb 20.

Responsible Party:	Taiho Pharmaceutical Co., Ltd. ( Taiho Pharmaceutical Co., Ltd. )
Study ID Numbers:	91023039
Study First Received:	September 7, 2005
Last Updated:	January 16, 2009
ClinicalTrials.gov Identifier:	NCT00150670 History of Changes
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by Taiho Pharmaceutical Co., Ltd.:

Stomach cancer

Study placed in the following topic categories:

Stomach Diseases
Digestive System Diseases
Digestive System Neoplasms
Radiation-Sensitizing Agents
Cisplatin

Gastrointestinal Diseases
Stomach Neoplasms
Gastrointestinal Neoplasms
Stomach Cancer

Additional relevant MeSH terms:

Digestive System Neoplasms
Gastrointestinal Diseases
Antineoplastic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Neoplasms
Neoplasms by Site

Digestive System Diseases
Stomach Diseases
Cisplatin
Radiation-Sensitizing Agents
Stomach Neoplasms
Therapeutic Uses
Gastrointestinal Neoplasms

ClinicalTrials.gov processed this record on August 30, 2009