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

Gastric Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00150670
• Other study ID #: 91023039
• Status: Completed
• Phase: Phase 3
• First received: September 7, 2005
• Last updated: July 6, 2011
• Start date: March 2002
• Est. completion date: December 2006

Study information

• Verified date: July 2011
• Source: Taiho Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: December 2006
• Est. primary completion date: December 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 74 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

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.
• 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.

Locations

Country	Name	City	State
Japan	East Hospital, Kitasato University	2-1-1, Asamizodai, Sagamihara	Kanagawa

Sponsors (1)

Lead Sponsor	Collaborator
Taiho Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Japan, 

References & Publications (1)

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 advance — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival		every course for first three courses, then every other course	No
Secondary	Overall response rate, lesion-directed response rate, time to treatment failure (TTF), hospitalization-free survival period within the periods of TTF, and safety profile		every course for first three courses, then every other course	Yes