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

This study has been terminated.
(Terminated after interim analysis)
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by:
ICO Paul Papin
ClinicalTrials.gov Identifier:
NCT00207831
First received: September 13, 2005
Last updated: July 20, 2010
Last verified: July 2010
  Purpose

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.


Condition Intervention Phase
Rectal Cancer
Stage II/III
T3 or T4 (Only Anal Extension) Rectal Cancer
N0-2
M0
Drug: Tegafur and Uracil
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Trial UFT/RT Randomized Multicenter Phase III Randomized Trial Testing Ftorafur (UFT) Associated With Neoadjuvant Radiotherapy Versus Radiotherapy Alone in Rectal Adenocarcinoma

Resource links provided by NLM:


Further study details as provided by ICO Paul Papin:

Primary Outcome Measures:
  • 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:
  • 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

Estimated Enrollment: 219
Study Start Date: July 2004
Study Completion Date: February 2008
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Tegafur uracile + radiotherapy Drug: Tegafur and Uracil
Active Comparator: radiotherapy 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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00207831

Locations
France
Clinique Sainte Catherine
Avignon, France, 84000
Hopital Avicenne
Bobigny, France, 93
Institut de Cancérologie et d'Hématologie
Brest, France, 29609
Centre Hospitalier
Brive La Gaillarde, France, 19312
Centre d'Oncologie-radiothérapie d'Eure et Loir
Chartres, France, 28006
Centre Jean Perrin
Clermont Ferrand, France, 63011
Centre Médical République
Clermont-ferrand, France, 63023
Clinique du Mail
Grenoble, France, 38100
Centre Hospitalier Départemental
La Roche Sur Yon, France, 85025
Centre Guillaume le Conquérant
Le Havre, France, 76600
Centre Oscar Lambret
Lille, France, 59020
Centre Hospitalier
Lorient, France, 56322
Centre léon Bérard
LYON Cedex 08, France, 69373
Centre Gray
Maubeuge, France, 59600
Clinique du Pont de Chaume
Montauban, France, 82017
Polyclinique St Roch
Montpellier, France, 34967
Clinique Valdegour
Nimes, France, 30900
Centre Hospitalier
Niort, France, 79021
Centre Hospitalier Universitaire
Poitiers, France, 86021
Centre Hospitalier de Cornouaille
Quimper, France, 29000
Centre Eugène Marquis
Rennes, France, 35042
Centre Hospitalier
Rodez, France, 12027
Centre Frédéric Joliot
Rouen, France, 76000
Clinique Armoricaine de Radiologie
Saint Brieuc, France, 22015
Centre de Radiothérapie
Strasbourg, France, 67000
Centre des Hautes Energies
Toulouse, France, 31400
Clinique Fleming
Tours, France, 37000
Sponsors and Collaborators
ICO Paul Papin
Merck Sharp & Dohme Corp.
Investigators
Study Chair: Patrice Cellier, MD ICO Paul Papin
Study Chair: Rémy Barraya, MD ICO Paul Papin
Study Chair: Christian Chevelle, MD Centre des Hautes Energie, Toulouse
Study Chair: Gérard Lorimier, MD ICO Paul Papin
Study Chair: Véronique Verrièle, MD ICO Paul Papin
Study Chair: Michèle Boisdron, Pct, PhD ICO Paul Papin
Study Chair: Loïc Campion, MD Centre René Gauducheau, Nantes
  More Information

No publications provided

Responsible Party: Centre Paul¨Papin, Gamelin Pr
ClinicalTrials.gov Identifier: NCT00207831     History of Changes
Other Study ID Numbers: CPP276
Study First Received: September 13, 2005
Last Updated: July 20, 2010
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by ICO Paul Papin:
rectal cancer
neoadjuvant therapy
UFT
radiochemotherapy

Additional relevant MeSH terms:
Adenocarcinoma
Rectal Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Tegafur
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 22, 2014