CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 546 enrolled
Drug / intervention
cisplatin +4 moredrug
Likely dose
Cisplatin and fluorouracil (5-FU) with leucovorin IV; epirubicin IV; concurrent with radiation therapy 5 days a week for 5 weeksAI-extracted
Key inclusion· 5
  • Histologically confirmed adenocarcinoma of stomach or gastroesophageal junction (esophageal adenocarcinoma not involving GE junction excluded)
  • Complete en bloc resection of all known tumor with curative intent
  • Tumor extension beyond muscularis propria and/or nodal involvement without M1 disease; eligible stages: IB (with N1 or T>muscularis propria), II, IIIA, IIIB, or IV (M0 only)
  • ECOG performance status 0, 1, or 2
Key exclusion· 7
  • Stages 0, IA, or any stage with M1 metastatic disease
  • Unresected cancer, recurrent cancer, positive margins, noncontiguous resection, or M1 disease
  • Any prior chemotherapy or radiotherapy
  • Uncontrolled cardiac conditions: high blood pressure, unstable angina, symptomatic CHF, MI <6 months, serious arrhythmia, or NYHA class III/IV

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

Search/NCT00052910
NCT00052910Phase 3Completed

Phase III Intergroup Trial of Adjuvant Chemoradiation After Resection of Gastric or Gastroesophageal Adenocarcinoma

Alliance for Clinical Trials in Oncology·interventional·Posted Jan 27, 2003·Updated May 7, 2020

In Brief

A Phase 3 clinical trial evaluating cisplatin, epirubicin hydrochloride, and 3 other interventions for Esophageal Cancer and Gastric Cancer. Completed, enrolled 546 participants across 535 sites in 2 countries.

Detailed Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy with radiation therapy after surgery may kill any remaining tumor cells following surgery. It is not yet known which chemotherapy and radiation therapy regimen is more effective in treating stomach or esophageal cancer. PURPOSE: Randomized phase III trial to compare two different chemotherapy and radiation therapy regimens in treating patients who have undergone surgery for stomach or esophageal cancer.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCanada, United States

Timeline

Phase 3CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 27, 2003
Enrollment StartDec 1, 2002
Primary CompletionJun 1, 2012
Study CompletionDec 1, 2016
TodayJul 2, 2026
Enrollment to primary: 9.5 yearsPosted 23.4 years ago

Interventions

cisplatindrug

Given IV

epirubicin hydrochloridedrug

Given IV

fluorouracildrug

Given IV

leucovorin calciumdrug

Given IV

radiation therapyradiation

Given 5 days a week for 5 weeks