Trial intelligence / Profile preview

Adjuvant IP Cisplatin and Chemotherapy in Gastric Cancer

NCT00296322Phase 3

Key facts

Status
Completed
Start
Oct 2001
Primary completion
Dec 2007
Countries
1
Sponsor
Asan Medical Center
Modality
Nanoparticles, Small Molecules
Conditions
gastric adenocarcinoma
01

Overview

Phase 3, randomised, open-label trial of Cisplatin micelle injection (HA132) in gastric adenocarcinoma (2 arms), sponsored by Asan Medical Center. Primary endpoint: Relapse-free Survival at 3 years. Started Oct 2001; status: completed.

02

Design

2 arms
Study design
RandomizedOpen-label
  • Mitomycin-C, Doxifluridine

    Standard adjuvant chemotherapy

  • Mitomycin-C, Doxifluridine, Cisplatin

    Intensified adjuvant chemotherapy with IP Cisplatin

03

Who it enrols

Patients with pathologically proven gastric adenocarcinoma, stage II-IV (excluding M1), aged 18-69, with adequate organ function and no prior chemo/radiotherapy.

04

Endpoints

Primary

  • Relapse-free Survival

Secondary

  • Toxicity Profile

  • Overall Survival

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