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Phase 3 Study of Xelox Followed by Maintenance Capecitabine in the Advanced Gastric Cancer

NCT02289547 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 184

Last updated 2017-06-14

No results posted yet for this study

Summary

XELOX regimen had a more favorable toxicity profile compared to cisplatin for patients with advanced gastric cancer. The safety profile of oxaliplatin makes it an ideal candidate for combination therapy. However, oxaliplatin induce sensory neuropathy, a cumulative, dose-related toxicity. It may therefore be possible to devise capecitabine maintenance regimen which achieves maximum treatment effect before cumulative neurotoxicity appears. We study that randomized Phase III study of Xelox (Capecitabine plus Oxaliplatin) followed by maintenance Capecitabine or Observation in the gastric cancer patients of stable disease after 6 cycle 1st line of XELOX chemotherapy .

Conditions

  • Stomach Neoplasms

Interventions

DRUG

Capecitabine

maintenance capecitabine therapy after six cycles of XELOX

Sponsors & Collaborators

  • The Catholic University of Korea

    lead OTHER

Principal Investigators

  • Byoungyong Shim, M.D.,Ph.D · St.Vincent's Hospital of The Catholic University of Korea

  • Young Seon Hong, M.D.,Ph.D · Seoul St. Mary's Hopital of The Catholic Univerisity of Korea

  • In Sook Woo, M.D.,Ph.D · St. Mary's Hospital of The Catholic University of Korea

  • Jae Ho Byun, M.D.,Ph.D · Incheon St. Mary's Hopital of The Catholic Univerisity of Korea

  • Cuk Jin Lee, M.D.,Ph.D · Bucheon St. Mary's Hopital of The Catholic Univerisity of Korea

  • Ji Chan Park, M.D.,Ph.D · Daejeon St. Mary's Hopital of The Catholic Univerisity of Korea

  • Yoon Ho Ko, M.D.,Ph.D · Ujeongbu St. Mary's Hopital of The Catholic Univerisity of Korea

  • Keun Wook Lee, M.D.,Ph.D · Bundang Seoul National Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-05-31
Primary Completion
2018-01-31
Completion
2019-01-31

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Drugs

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 NCT02289547 on ClinicalTrials.gov