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

Chinese Academy of Medical Sciences43 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Stomach Neoplasms

Interventions

OxaliplatinDRUG

130mg/m2 d1,repeated q21d

s1DRUG

80mg/m2/d, d1-14,repeated q21d

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

cancer hospital & Institute,Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

Outcomes

Primary Outcomes

Progression Free Survival

from date of treatment was administered until the date of first documented progression or death from any cause whichever first, assessed every 6 weeks

Time frame: 2 years

Secondary Outcomes

Response Rate

From date of treatment was administered until the date of first documented response to treatment according to RECIST criteria,assessed every 2 cycles

Time frame: 2 years

overall survival

From date of treatment was administered until the date of death from any cause,assessed every 3 months

Time frame: 2 years

number of participants with adverse events

assessed from treatment was administered until 1 months after withdrawing from study

Time frame: 2 years

Data from ClinicalTrials.gov

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