CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 63 enrolled
Drug / intervention
Capecitabine Oral Product +1 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/NCT03428529
NCT03428529Phase 3Completed
CompareCT.gov

Estudo Randomizado de Fase II Com Capecitabina Versus 5-Fluorouracil/Leucovorin em Bolus Associados à Radioterapia no Tratamento Neoadjuvante de câncer de Reto Localmente avançado: INCAGI004.

Instituto Nacional de Cancer, Brazil·interventional·Posted Feb 9, 2018·Updated Feb 9, 2018

In Brief

A Phase 3 clinical trial evaluating Capecitabine Oral Product and 5Fluorouracil for Rectal Neoplasm Malignant. Completed, enrolled 63 participants.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRectal Neoplasm Malignant
Countries--
Collaborators--

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedFeb 9, 2018
Enrollment StartJan 12, 2011
Primary CompletionOct 13, 2016
Study CompletionDec 13, 2016
TodayJul 2, 2026
Enrollment to primary: 5.8 yearsPosted 8.4 years ago

Interventions

Capecitabine Oral Productdrug

Neoadjuvant Capecitabine concomitant to external beam radiotherapy

5Fluorouracildrug

Neoadjuvant bolus 5-Fluorouracil concomitante to external beam radiotherapy