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

Primary Purpose

Stomach Neoplasms

Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Oxaliplatin
s1
Sponsored by
Chinese Academy of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stomach Neoplasms focused on measuring Stomach Neoplasms, drug therapy, oxaliplatin, s1

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • cancer hospital & Institute,Chinese Academy of Medical Sciences

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

treatment

Arm Description

oxaliplatin+s1

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
February 6, 2012
Last Updated
December 3, 2014
Sponsor
Chinese Academy of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT01531452
Brief Title
The Efficacy of Oxaliplatin Plus S-1 for Treatment of Gastric Cancer
Official Title
a Phase II Study of Oxaliplatin Plus S-1 (SOX) as First-line Treatment for Patients With Advanced Gastric Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
June 2011 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese Academy of Medical Sciences

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stomach Neoplasms
Keywords
Stomach Neoplasms, drug therapy, oxaliplatin, s1

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
43 (Actual)

8. Arms, Groups, and Interventions

Arm Title
treatment
Arm Type
Experimental
Arm Description
oxaliplatin+s1
Intervention Type
Drug
Intervention Name(s)
Oxaliplatin
Other Intervention Name(s)
eloxatin
Intervention Description
130mg/m2 d1,repeated q21d
Intervention Type
Drug
Intervention Name(s)
s1
Other Intervention Name(s)
TS-1
Intervention Description
80mg/m2/d, d1-14,repeated q21d
Primary Outcome Measure Information:
Title
Progression Free Survival
Description
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 Outcome Measure Information:
Title
Response Rate
Description
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
Title
overall survival
Description
From date of treatment was administered until the date of death from any cause,assessed every 3 months
Time Frame
2 years
Title
number of participants with adverse events
Description
assessed from treatment was administered until 1 months after withdrawing from study
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jinwan Wang, MD
Organizational Affiliation
cancer hospital&institute,Chinese Academy of Medical Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
cancer hospital & Institute,Chinese Academy of Medical Sciences
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100021
Country
China

12. IPD Sharing Statement

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

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