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S-1 vs Capecitabine in the Elderly and/or Poor Performance Status Patients With Recurrent or Metastatic Gastric Cancer

NCT00580359 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2008-01-08

No results posted yet for this study

Summary

This study is an open-label, single-center, and randomized phase II study designed to evaluate each efficacy and safety of S-1 and capecitabine in the elderly and/or poor performance status patients with recurrent or metastatic gastric cancer. The randomization will be stratified by age (70-85 years versus 65 years and \< 70 years) and performance status, which is dependent on age group; in 70-85 years, ECOG performance status 0-1 versus 2 and in ³65 years and \<70 years, ECOG performance status 2 versus 3.

* S-1 40mg/m2 orally twice daily on days 1 (evening) - 15 (morning)
* Capecitabine 1250mg/m2 orally twice daily on days 1 (evening) - 15 (morning) Treatment will be administered every 3 weeks and will be continued in the absence of disease progression or unacceptable toxicity.

Conditions

  • Stomach Neoplasms

Interventions

DRUG

S-1, capecitabine

S-1 40mg/m2 orally twice daily on days 1(evening) - 15 (morning)every 3 weeks, until disease progression, Capecitabine 1250mg/m2 orally twice daily on days 1 (evening) - 15 (morning)every 3 weeks, until disease progression

Sponsors & Collaborators

  • National Cancer Center, Korea

    lead OTHER_GOV

Principal Investigators

  • Sook Ryun Park, M.D · National Cancer Center, Korea

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
60 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-05-31
Primary Completion
2009-12-31
Completion
2010-06-30

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00580359 on ClinicalTrials.gov