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:
ICO Paul Papin
Collaborator:
Merck
Information provided by:
ICO Paul Papin
ClinicalTrials.gov Identifier:
NCT00207831
First received: September 13, 2005
Last updated: July 20, 2010
Last verified: July 2010
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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
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
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 Adenocarcinoma, Mucinous Rectal Neoplasms Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Neoplasms, Cystic, Mucinous, and Serous 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 May 16, 2013