Randomized phase II study comparing S-1 plus oxaliplatin with S-1 monotherapy for elderly patients with advanced gastric cancer.(WJOG8315G)

UMIN ID: UMIN000020864

Registered date:03/02/2016

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: advanced gastric cancer.
• Date of first enrollment: 2016/04/12
• Target sample size: 160
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

S-1 monotherapy S-1 was administered at 80mg/m2/BID (p.o.), on days 1-28 every 6 weeks until disease progression.
S-1 + oxaliplatin S-1 plus oxaliplatin every 3 weeks until disease progression S-1: 80mg/m2/BID (p.o.), on days 1-14 Oxaliplatin: 100mg/m2 (i.v.) on day 1

Outcome(s)

• Primary Outcome: overall survival
• Secondary Outcome: progression free survival,time to treatment failure,response rate,safety

Key inclusion & exclusion criteria

• Age minimum: 70years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: 1) Synchronous or metachronous (within 5 years) malignancies other than carcinoma in situ or mucosal carcinoma. 2) Active infection under treatment 3) Peripheral sensory neuropathy of grade >= 2 according to NCI-CTCAE version 4.0. 4) Diarrhea of grade >= 2 according to NCI-CTCAE version 4.0. 5) Pulmonary fibrosis or interstitial pneumonitis detected by chest x-ray. 6) Receiving flucytosine 7) Receiving phenytoin or warfarin potassium 8) Current treatment with corticosteroids. 9) Pregnant or lactating female. 10) Uncontrolled psychiatry disease 11) History of serious allergic reactions. 12) Evidence of any other serious disease, e.g. COPD, uncontrolled diabetes mellitus, uncontrolled hypertension, uncontrolled cardiovascular disease, Cerebral infarction within one year, active gastrointestinal hemorrhage, blood tests positive for HBs antigen or HVC antibody. 13) Judged inappropriate by the investigators.

Related Information

• Primary Sponsor: West Japan Oncology Group
• Source(s) of Monetary Support: Japan Agency for Medical Research and Development