CI

At a glance

ClinicalIndex Comparison Record
Phase 3Unknown· 1,608 enrolled
Drug / intervention
capecitabine +3 moredrug
Likely dose
capecitabine 825 mg/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/NCT00058474
NCT00058474Phase 3Unknown

A Clinical Trial Comparing Preoperative Radiation Therapy And Capecitabine With or Without Oxaliplatin With Preoperative Radiation Therapy And Continuous Intravenous Infusion Of 5-Fluorouracil With or Without Oxaliplatin In The Treatment Of Patients With Operable Carcinoma Of The Rectum

NSABP Foundation Inc·interventional·Posted Apr 9, 2003·Updated Mar 23, 2016

In Brief

A Phase 3 clinical trial evaluating capecitabine, fluorouracil, and 2 other interventions for Colorectal Cancer. Targeting 1,608 participants.

Detailed Summary

RATIONALE: Drugs used in chemotherapy, such as capecitabine, fluorouracil, and oxaliplatin work in 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. PURPOSE: This randomized phase III trial is studying radiation therapy and either capecitabine or fluorouracil with or without oxaliplatin and comparing them to see how well they work when given before surgery in treating patients with resectable rectal cancer. It is not yet known whether radiation therapy and either capecitabine or fluorouracil is more effective with or without oxaliplatin in treating rectal cancer.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
Countries--

Timeline

Phase 3UnknownOverdue
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 9, 2003
Enrollment StartJul 1, 2004
Primary CompletionAug 1, 2013
Study CompletionMay 1, 2016
TodayJul 1, 2026
Enrollment to primary: 9.1 yearsPosted 23.2 years ago

Interventions

capecitabinedrug

825 mg/m2 oral daily 5 days a week on days of planned RT

fluorouracildrug

225 mg/m2 IV daily continuous infusion

oxaliplatindrug

50 mg/m2 IV 5 days a week on days of planned RT

radiation therapyradiation

Given 5 days a week for 5-6 weeks