At a glance

ClinicalIndex Comparison Record

Phase 3Completed· 528 enrolled

Drug / intervention

cisplatin, mitomycin-C, doxifluridinedrug

Likely dose

cisplatin, mitomycin-C, doxifluridine 20mg/m2from record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00296322

NCT00296322Phase 3Completed

Compare CT.gov

A Phase III Randomized Controlled Trial of Adjuvant Chemotherapy for Gastric Adenocarcinoma: Mitomycin and Doxifluridine Versus Intraperitoneal Chemotherapy and Mitomycin, Doxifluridine, and Cisplatin

Asan Medical Center·interventional·Posted Feb 27, 2006·Updated Jan 18, 2020

In Brief

A Phase 3 clinical trial evaluating cisplatin, mitomycin-C, doxifluridine for Stomach Cancer. Completed, enrolled 528 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsStomach Cancer

CountriesSouth Korea

CollaboratorsUlsan University Hospital, Hallym University Medical Center

Timeline

Phase 3CompletedFinished

20022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027

Enrollment StartOct 2001

First PostedFeb 2006

Primary CompletionDec 2007

Study CompletionMar 2010

TodayJul 2026

First PostedFeb 27, 2006

Enrollment StartOct 1, 2001

Primary CompletionDec 1, 2007

Study CompletionMar 1, 2010

TodayJul 2, 2026

Enrollment to primary: 6.2 yearsPosted 20.3 years ago

Interventions

cisplatin, mitomycin-C, doxifluridinedrug

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)