Trial Testing Ftorafur (UFT) Associated With Neoadjuvant Radiotherapy Versus Radiotherapy Alone in Rectal Adenocarcinoma
- Conditions
- Stage II/IIIT3 or T4 (Only Anal Extension) Rectal CancerN0-2M0Rectal Cancer
- Interventions
- Registration Number
- NCT00207831
- Lead Sponsor
- Institut Cancerologie de l'Ouest
- Brief Summary
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.
- 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
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 219
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Tegafur uracile + radiotherapy Tegafur and Uracil - radiotherapy Tegafur and Uracil -
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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 safety of the chemoradiotherapy regimen to radiotherapy alone Compare overall survival Compare the rate of sphincter conservation 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
Trial Locations
- Locations (24)
Centre Guillaume le Conquérant
🇫🇷Le Havre, France
Centre Oscar Lambret
🇫🇷Lille, France
Clinique du Pont de Chaume
🇫🇷Montauban, France
Centre Hospitalier de Cornouaille
🇫🇷Quimper, France
Clinique Fleming
🇫🇷Tours, France
Centre des Hautes Energies
🇫🇷Toulouse, France
Centre de Radiothérapie
🇫🇷Strasbourg, France
Institut de Cancérologie et d'Hématologie
🇫🇷Brest, France
Hopital Avicenne
🇫🇷Bobigny, France
Clinique Sainte Catherine
🇫🇷Avignon, France
Centre Hospitalier
🇫🇷Rodez, France
Centre d'Oncologie-radiothérapie d'Eure et Loir
🇫🇷Chartres, France
Centre Hospitalier Départemental
🇫🇷La Roche Sur Yon, France
Clinique du Mail
🇫🇷Grenoble, France
Centre Jean Perrin
🇫🇷Clermont Ferrand, France
Centre Médical République
🇫🇷Clermont-ferrand, France
Centre léon Bérard
🇫🇷LYON Cedex 08, France
Centre Gray
🇫🇷Maubeuge, France
Polyclinique St Roch
🇫🇷Montpellier, France
Clinique Valdegour
🇫🇷Nimes, France
Centre Hospitalier Universitaire
🇫🇷Poitiers, France
Centre Eugène Marquis
🇫🇷Rennes, France
Centre Frédéric Joliot
🇫🇷Rouen, France
Clinique Armoricaine de Radiologie
🇫🇷Saint Brieuc, France