Capecitabine Versus Bolus 5-Fu Associated to Radiotherapy as Neoadjuvant Treatment for Rectal Cancer. (INCAGI004)

February 5, 2018 updated by: Rodrigo Otavio de Castro Araujo, Instituto Nacional de Cancer, Brazil

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.

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Patients harbouring rectal adenocarcinoma T3-4 or N>0 M0 within 10 cm to anal verge were randomized in two treatment arms: (1) capecitabina orally 825mg/m2 bid. 5 days a week for 5 weeks and (2) bolus intravenous 5-FU/LV 350mg/m2/20 mg/m2 D1-D5 on the first and fifth weeks, both combined to pelvic radiotherapy, total dose 50.4 Gy in 28 fractions. Clinical stage before and after CRT was determined using pelvic Magnetic Resonance Imaging (MRI), endorectal ultrasonography (ERUS) and chest, abdominal and pelvic Computer Tomography. Surgery was planned 6 to 8 weeks after CRT. Sphincter preservation was always considered when negative margins were possible. Pathological assessment included stage (TNM 7th Ed.) and Mandard's Tumor Regression Grade (TRG). QOL questionnaires QLQ-C30 and CR38 were completed by patients before and after CRT, after surgery and during follow-up.

Study Type

Interventional

Enrollment (Actual)

63

Phase

  • Phase 2
  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Patients with histologically proven locally advanced rectal cancer (cT3-4 or positive regional lymph node) on endorectal ultrasonography (EUS) or pelvic Magnetic Resonance Imaging (MRI) were qualified for this study. Distance from anal verge (AV) should not exceed 10 cm measured with rigid proctoscopy. Thorax and abdominal computer tomography (CT) exams were taken to rule out distant metastasis. Performance Status ECOG 0-1.

Exclusion Criteria:

Previous treatment for rectal cancer (RT, chemotherapy or surgical resection). Previous diagnosis of other cancers except nonmelanoma skin cancer. Uncontrolled comorbities including heart failure and miocardial infarction in the previous 6 months. Hepatic insufficiency and renal failure. Pregnancy. Serious neurologic or psyquiatric disturbances that could affect comprehension of informed consent.

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Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Capecitabine
Neoadjuvant capecitabine plus RT
Drug: Capecitabine Oral Product
Neoadjuvant Capecitabine concomitant to external beam radiotherapy
Other Names:
  • Xeloda
Active Comparator: 5-Flourouracil
Neoadjuvant 5-Fluorouracil plus RT
Drug: 5Fluorouracil
Neoadjuvant bolus 5-Fluorouracil concomitante to external beam radiotherapy
Other Names:
  • 5-Fu

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical downstaging
Time Frame: 6-8 weeks after CRT
Clinical downstaging after neoadjuvant treatment
6-8 weeks after CRT

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pathological downstaging
Time Frame: 8 weeks after CRT
Patholgical downstaging after neoadjuvant treatment
8 weeks after CRT

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto Nacional de Cancer, Brazil

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 12, 2011

Primary Completion (Actual)

October 13, 2016

Study Completion (Actual)

December 13, 2016

Study Registration Dates

First Submitted

February 5, 2018

First Submitted That Met QC Criteria

February 5, 2018

First Posted (Actual)

February 9, 2018

Study Record Updates

Last Update Posted (Actual)

February 9, 2018

Last Update Submitted That Met QC Criteria

February 5, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CEP INCA 83/10

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

IPD could be shared if requested after IRB approval.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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