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Capecitabine Versus Bolus 5-Fu Associated to Radiotherapy as Neoadjuvant Treatment for Rectal Cancer.

NCT03428529 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 63

Last updated 2018-02-09

No results posted yet for this study

Summary

A randomized two-arm study comparing preoperative CRT using oral capecitabine versus bolus 5-FU/LV concomitant to external beam radiation (50.5 Gy/28 fractions) for locally advanced rectal cancer. Main outcome was clinical response assessed using MRI and endorectal US 6-8 weeks after CRT. Secondary endpoints were pathological response, adverse effects, sphyncter preservation, quality of life, OS and DFS.

Conditions

  • Rectal Neoplasm Malignant

Interventions

DRUG

Capecitabine Oral Product

Neoadjuvant Capecitabine concomitant to external beam radiotherapy

DRUG

5Fluorouracil

Neoadjuvant bolus 5-Fluorouracil concomitante to external beam radiotherapy

Sponsors & Collaborators

  • Instituto Nacional de Cancer, Brazil

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-01-12
Primary Completion
2016-10-13
Completion
2016-12-13

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03428529 on ClinicalTrials.gov