Trial Testing Ftorafur (UFT) Associated With Neoadjuvant Radiotherapy Versus Radiotherapy Alone in Rectal Adenocarcinoma (UFT RT Phase 3)

March 23, 2020 updated by: Institut Cancerologie de l'Ouest

Trial UFT/RT Randomized Multicenter Phase III Randomized Trial Testing Ftorafur (UFT) Associated With Neoadjuvant Radiotherapy Versus Radiotherapy Alone in Rectal Adenocarcinoma

RATIONALE: Drugs used in chemotherapy, such as 5-fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing and also as a radiosensibilisant. Radiation therapy uses high-energy x-rays to kill tumor cells. 5-fluorouracil may make tumor cells more sensitive to radiation therapy. Oral 5-fluorouracil is more convenient for ambulatory patients. Giving UFT (Tegafur and Uracil) with radiation therapy before surgery may shrink the tumor so it can be removed.

PURPOSE: This phase III trial is studying how well giving UFT with radiation therapy works in treating patients who are undergoing surgery for operable rectal cancer.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Adenocarcinoma of the rectum

Stage II/stage III rectal cancer (if T4 only anal extension eligible)

Drug: UFT

Procedure: chemotherapy

Procedure: conventional surgery

Procedure: neoadjuvant therapy

Procedure: radiation therapy

Procedure: radiosensitization

Procedure: surgery

Study Type

Interventional

Enrollment (Actual)

219

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Avignon, France, 84000
        • Clinique Sainte Catherine
      • Bobigny, France, 93
        • Hôpital Avicenne
      • Brest, France, 29609
        • Institut de Cancérologie et d'Hématologie
      • Brive La Gaillarde, France, 19312
        • Centre Hospitalier
      • Chartres, France, 28006
        • Centre d'Oncologie-radiothérapie d'Eure et Loir
      • Clermont Ferrand, France, 63011
        • Centre Jean Perrin
      • Clermont-ferrand, France, 63023
        • Centre Médical République
      • Grenoble, France, 38100
        • Clinique du Mail
      • LYON Cedex 08, France, 69373
        • Centre Léon Bérard
      • La Roche Sur Yon, France, 85025
        • Centre Hospitalier departemental
      • Le Havre, France, 76600
        • Centre Guillaume Le Conquerant
      • Lille, France, 59020
        • Centre Oscar Lambret
      • Lorient, France, 56322
        • Centre Hospitalier
      • Maubeuge, France, 59600
        • Centre Gray
      • Montauban, France, 82017
        • Clinique du Pont de Chaume
      • Montpellier, France, 34967
        • Polyclinique St Roch
      • Nimes, France, 30900
        • Clinique Valdegour
      • Niort, France, 79021
        • Centre Hospitalier
      • Poitiers, France, 86021
        • Centre Hospitalier Universitaire
      • Quimper, France, 29000
        • Centre Hospitalier de Cornouaille
      • Rennes, France, 35042
        • Centre Eugène Marquis
      • Rodez, France, 12027
        • Centre Hospitalier
      • Rouen, France, 76000
        • Centre Frédéric JOLIOT
      • Saint Brieuc, France, 22015
        • Clinique Armoricaine de Radiologie
      • Strasbourg, France, 67000
        • Centre de Radiotherapie
      • Toulouse, France, 31400
        • Centre des Hautes Energies
      • Tours, France, 37000
        • Clinique Fleming

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

DISEASE CHARACTERISTICS:

  • Histologically confirmed invasive adenocarcinoma of the rectum , M0, lower side < 10 cm from anal verge
  • T3 or T4 disease (T4 exclusive anal extension )

PATIENT CHARACTERISTICS:

Performance status

  • ECOG 0-2 OR
  • Zubrod 0-2

Life expectancy

  • Not specified

Hematopoietic

  • Absolute neutrophil count > 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3

Hepatic

  • Bilirubin < x2 UNL

Renal

  • Creatinine < 150 µMol/L

Gastrointestinal

  • No history of inflammatory bowel disease
  • No history of difficulty or inability to take or absorb oral medications

Neurologic

  • Not specified

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No other malignancy within the past 5 years except curatively treated basal cell skin cancer or carcinoma in situ of the cervix
  • No history of psychiatric conditions or diminished mental capacity that would preclude study compliance or giving informed consent

PRIOR CONCURRENT THERAPY:

Chemotherapy

  • No prior chemotherapy

Radiotherapy

  • No prior radiotherapy to the pelvis

Other

  • No other concurrent investigational drugs
  • No other concurrent anticancer treatment

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
Active Comparator: radiotherapy
Drug: Tegafur and Uracil
Experimental: Tegafur uracile + radiotherapy
Drug: Tegafur and Uracil

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Compare the rate of pathologic complete response of the primary tumor in patients with operable rectal cancer receiving preoperative chemoradiotherapy versus patients receiving radiotherapy alone

Secondary Outcome Measures

Outcome Measure
Compare endoscopic ultrasonographic response in patients with operable rectal cancer receiving preoperative chemoradiotherapy versus patients receiving radiotherapy alone.
Compare quality of life (Quality of Life Questionnaire Core 30 Items [QLQ-C 30])
Compare the rate of sphincter conservation alone.
Compare the safety of the chemoradiotherapy regimen to radiotherapy alone
Compare the rate of resectability with negative resection margins in patients treated with this two regimen.
Compare recurrence free survival and disease free survival
Compare overall survival

Collaborators and Investigators

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

Sponsor

Institut Cancerologie de l'Ouest

Collaborators

Merck Sharp & Dohme LLC

Investigators

  • Study Chair: Patrice Cellier, MD, Institut Cancerologie de l'Ouest
  • Study Chair: Rémy Barraya, MD, Institut Cancerologie de l'Ouest
  • Study Chair: Christian Chevelle, MD, Centre des Hautes Energie, Toulouse
  • Study Chair: Gérard Lorimier, MD, Institut Cancerologie de l'Ouest
  • Study Chair: Véronique Verrièle, MD, Institut Cancerologie de l'Ouest
  • Study Chair: Michèle Boisdron, Pct, PhD, Institut Cancerologie de l'Ouest
  • Study Chair: Loïc Campion, MD, Centre rené Gauducheau, NANTES

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)

July 1, 2004

Primary Completion (Actual)

June 1, 2007

Study Completion (Actual)

February 1, 2008

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (Estimate)

September 21, 2005

Study Record Updates

Last Update Posted (Actual)

March 25, 2020

Last Update Submitted That Met QC Criteria

March 23, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CPP276

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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