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

a Phase II Study of Oxaliplatin Plus S-1 (SOX) as First-line Treatment for Patients With Advanced Gastric Cancer

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

Study Overview

• Status: Completed
• Conditions: Stomach Neoplasms
• Intervention / Treatment: Drug: Oxaliplatin; Drug: s1

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 43
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100021
      • Cancer hospital & Institute,Chinese Academy of Medical Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: treatment; oxaliplatin+s1	Drug: Oxaliplatin; 130mg/m2 d1,repeated q21d; Other Names: eloxatin; Drug: s1; 80mg/m2/d, d1-14,repeated q21d; Other Names: TS-1

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	2 years
overall survival	From date of treatment was administered until the date of death from any cause,assessed every 3 months	2 years
number of participants with adverse events	assessed from treatment was administered until 1 months after withdrawing from study	2 years

Collaborators and Investigators

• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
• Investigators: Principal Investigator: Jinwan Wang, MD, Cancer hospital&institute,Chinese Academy of Medical Sciences

Study record dates

Study Major Dates

• Study Start: June 1, 2011
• Primary Completion (Actual): November 1, 2012
• Study Completion (Actual): June 1, 2013

Study Registration Dates

• First Submitted: February 6, 2012
• First Submitted That Met QC Criteria: February 10, 2012
• First Posted (Estimate): February 13, 2012

Study Record Updates

• Last Update Posted (Estimate): December 4, 2014
• Last Update Submitted That Met QC Criteria: December 3, 2014
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Keywords: oxaliplatin; Stomach Neoplasms; drug therapy; s1
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Stomach Diseases; Stomach Neoplasms; Antineoplastic Agents; Oxaliplatin
• Other Study ID Numbers: CH-GI-016