Clinical trial NCT00150670: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Gastric Cancer
Keywords: Stomach cancer
Lead sponsor: Taiho Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2005-09-08
Enrollment: 300
Sex: ALL
Minimum age (years): 20
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Overall survival
timeFrame: every course for first three courses, then every other course
Secondary outcomes:
measure: Overall response rate, lesion-directed response rate, time to treatment failure (TTF), hospitalization-free survival period within the periods of TTF, and safety profile
timeFrame: every course for first three courses, then every other course
Other outcomes:
Locations:
city: 2-1-1, Asamizodai, Sagamihara
country: Japan
facility: East Hospital, Kitasato University
state: Kanagawa
Study officials:
affiliation: East Hospital, Kitasato University
name: Wasaburo Koizumi, MD, PHD
role: PRINCIPAL_INVESTIGATOR
References:
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.