CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,011 enrolled
Drug / intervention
fluorouracil +3 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/NCT00002523
NCT00002523Phase 3Completed

FOUR ARMS PHASE III CLINICAL TRIAL FOR T3-T4 RESECTABLE RECTAL CANCER COMPARING PRE-OPERATIVE PELVIC IRRADIATION TO PRE-OPERATIVE IRRADIATION COMBINED WITH FLUOROURACIL AND LEUCOVORIN WITH OR WITHOUT POST-OPERATIVE ADJUVANT CHEMOTHERAPY

European Organisation for Research and Treatment of Cancer - EORTC·interventional·Posted Jan 27, 2003·Updated Sep 2, 2016

In Brief

A Phase 3 clinical trial evaluating fluorouracil, leucovorin calcium, and 2 other interventions for Colorectal Cancer. Completed, enrolled 1,011 participants across 35 sites in 10 countries.

Detailed Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug, giving the drugs in different ways, and combining radiation therapy and surgery with chemotherapy may kill more tumor cells. PURPOSE: Randomized phase III trial to compare radiation therapy alone before surgery with radiation therapy plus fluorouracil and leucovorin before surgery, with and without fluorouracil and leucovorin after surgery in patients with rectal cancer that can be surgically removed.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesBelgium, France, Germany, Israel, Netherlands, Poland, Serbia, Spain, Switzerland, Turkey (Türkiye)
Collaborators--

Timeline

Phase 3CompletedFinished
19931994199519961997199819992000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 27, 2003
Enrollment StartApr 1, 1993
Primary CompletionMar 1, 2003
Study CompletionJan 1, 2016
TodayJul 2, 2026
Enrollment to primary: 9.9 yearsPosted 23.4 years ago

Interventions

fluorouracildrug

leucovorin calciumdrug

conventional surgeryprocedure

radiation therapyradiation