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

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: Rectal Cancer; Stage II/III; T3 or T4 (Only Anal Extension) Rectal Cancer; N0-2; M0
• Intervention / Treatment: Drug: Tegafur and Uracil

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

Study Locations

• France
  • Avignon, France, 84000
    • Clinique Sainte Catherine
  • Bobigny, France, 93
    • Hopital 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 Conquérant
  • 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 Eugene 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

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

How is the study designed?

Design Details

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

Number of Arms

2

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

• 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

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: rectal cancer; neoadjuvant therapy; radiochemotherapy; UFT
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Carcinoma; Neoplasms, Glandular and Epithelial; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Adenocarcinoma; Rectal Neoplasms; Molecular Mechanisms of Pharmacological Action; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Tegafur
• Other Study ID Numbers: CPP276