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Trial of Adjuvant Chemotherapy for Gastric Cancer

NCT00296322 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 528

Last updated 2020-01-18

Study results available
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Summary

This study is designed to evaluate the efficacy of the intraperitoneal chemotherapy with early mitomycin administration and adding cisplatin to prolonged treatment with doxifluridine compared to mitomycin plus doxifluridine in resected advanced gastric cancer.

Conditions

  • Stomach Cancer

Interventions

DRUG

cisplatin, mitomycin-C, doxifluridine

Mf: Mitomycin-C 20mg/m2 intravenously (3-6 weeks after surgery) Doxifluridine 460-600mg/m2/day per oral for 3 months (started 4 weeks after surgery) iceMFP: Cisplatin 100mg with 1L of normal saline intraperitoneally for 2 hours during surgery Mitomycin-C 15mg/m2 intravenously (1 day after surgery) Doxifluridine 460-600mg/m2/day per oral(started at 4 weeks after surgery and administered a total of 12 months) Cisplatin 60mg/m2 intravenously monthly for 6 months (started at 4 weeks after surgery)

Sponsors & Collaborators

  • Ulsan University Hospital

    collaborator OTHER

  • Hallym University Medical Center

    collaborator OTHER

  • Asan Medical Center

    lead OTHER

Principal Investigators

  • Yoon-Koo Kang, M.D.,Ph.D. · Asan Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
69 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2001-10-31
Primary Completion
2007-12-31
Completion
2010-03-31

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 NCT00296322 on ClinicalTrials.gov