CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 195 enrolled
Drug / intervention
cisplatin +4 moredrug
Likely dose
Not stated in 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/NCT00047112
NCT00047112Phase 3Completed

Randomized Study of Pre-Operative Radio-Chemotherapy Versus Surgery Alone in Thoracic Esophageal Cancer Deemed to be Resectable

Federation Francophone de Cancerologie Digestive·interventional·Posted Jan 27, 2003·Updated Mar 30, 2020

In Brief

A Phase 3 clinical trial evaluating cisplatin, fluorouracil, and 3 other interventions for Esophageal Cancer. Completed, enrolled 195 participants across 73 sites in 4 countries.

Detailed Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving combination chemotherapy with radiation therapy before surgery may shrink the tumor so it can be removed during surgery. It is not yet known if surgery is more effective with or without radiation therapy and chemotherapy in treating esophageal cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of surgery with or without radiation therapy and chemotherapy in treating patients who have esophageal cancer.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesBelgium, France, Germany, Netherlands

Timeline

Phase 3CompletedFinished
20022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 27, 2003
Enrollment StartMay 1, 2002
Primary CompletionSep 1, 2010
TodayJul 2, 2026
Enrollment to primary: 8.3 yearsPosted 23.4 years ago

Interventions

cisplatindrug

fluorouracildrug

conventional surgeryprocedure

neoadjuvant therapyprocedure

radiation therapyradiation