The Efficacy of Oxaliplatin Plus S-1 for Treatment of Gastric Cancer

Chinese Academy of Medical Sciences & Peking Union Medical College

Status and phase: Completed; Phase 2

Conditions: Stomach Neoplasms

Treatments: Drug: s1; Drug: Oxaliplatin

Study type: Interventional

Funder types: Other

Identifiers

NCT01531452

CH-GI-016

Details and patient eligibility

About

The purpose of this study is to determine the efficacy and safety of oxaliplatin and s1 as first-line treatment of advanced gastric cancer.

Full description

There was no evidence of standard chemotherapy for advanced gastric cancer (AGC) in China. Fluoropyrimidines and cisplatin have been widely used in a variety of combinations in the treatment of AGC. Capecitabine/cisplatin combination therapy showed an overall response rate (ORR) of 41- 55%, a median time to progression/progression free survival (TTP/PFS) of 5.6-6.3 months, and a median overall survival (OS) of 10.1-10.5 months. Though no studies have compared two oral fluoropyrimidines in combination with oxaliplatin, both S-1 and capecitabine appear to be comparable in terms of efficacy and safety. The investigators conducted a phase II trial of oxaliplatin combined with S-1 in the treatment of first-line AGC.

Enrollment: 43 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histologically proven in operable advanced gastric adenocarcinoma (including adenocarcinoma of the gastrooesophageal junction) or relapse gastric adenocarcinoma
• Measurable lesion and/or non-measurable lesion defined by RECIST
• ECOG performance status ≦ 1
• Hgb ≧ 8g/dL, WBC 4000-12000/mm3, platelets ≧ 100,000/mm3
• Creatine ≦ upper normal limit (UNL)
• Total bilirubin ≦ 1.5 X UNL
• AST, ALT and ALP ≦ 2.5 x UNL
• Subjects must be able to take orally
• No prior chemotherapy
• Life expectancy estimated than 3 months
• Written informed consent

Exclusion criteria

• Pregnancy or lactation women, or women with suspected pregnancy or men with willing to get pregnant
• Known brain metastases
• History of hypersensitivity to fluoropyrimidines, oxaliplatin
• Active double cancer
• Treatment with any investigational product during the last 4 weeks prior to study entry
• Symptomatic peripheral neuropathy ≧ garde 2. by NCI-CTCAE ver.3.0
• Any previous chemotherapy or radiotherapy for AGC

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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43 participants in 1 patient group

treatment

Experimental group

Description:

oxaliplatin+s1

Treatment:

Drug: Oxaliplatin

Drug: s1