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

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Trial Identification

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

Official Title: A Randomized Phase II Study of S-1 Versus Capecitabine as First-Line Chemotherapy in the Elderly and/or Poor Performance Status Patients With Recurrent or Metastatic Gastric Cancer

Study ID: NCT00580359

Interventions

S-1, capecitabine

Study Description

Brief 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.

Detailed Description:

Eligibility

Minimum Age: 60 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

National Cancer Center Korea, Goyang, Gyeonggi, Korea, Republic of

Contact Details

Name: Sook Ryun Park, M.D

Affiliation: National Cancer Center, Korea

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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