Surgery With or Without Radiation Therapy and Chemotherapy in Treating Patients With Esophageal Cancer
- Conditions
- Esophageal Cancer
- Interventions
- Procedure: conventional surgeryProcedure: neoadjuvant therapyRadiation: radiation therapy
- Registration Number
- NCT00047112
- Lead Sponsor
- Federation Francophone de Cancerologie Digestive
- Brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving combination chemotherapy with radiation therapy before surgery may shrink the tumor so it can be removed during surgery. It is not yet known if surgery is more effective with or without radiation therapy and chemotherapy in treating esophageal cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of surgery with or without radiation therapy and chemotherapy in treating patients who have esophageal cancer.
- Detailed Description
OBJECTIVES:
* Compare the overall survival of patients with resectable thoracic esophageal cancer treated with neoadjuvant radio-chemotherapy and surgery versus surgery alone.
* Compare the disease-free survival of patients treated with these regimens.
* Compare the surgical mortality and morbidity of patients treated with these regimens.
* Compare the resectability of patients treated with these regimens.
* Determine the validation of new prognostic factors for survival of these patients and/or the efficacy of this neoadjuvant treatment.
OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to histology (epidermoid carcinoma vs adenocarcinoma vs undifferentiated carcinoma), stage (I vs IIA vs IIB), tumor location (above the carina vs below the carina), and participating center. Patients are randomized to 1 of 2 treatment arms.
* Arm I: Patients undergo radiotherapy daily 5 days a week for 5 weeks. Patients receive fluorouracil IV continuously on days 1-4 and 29-32 and cisplatin IV on days 1 or 2 and 29 or 30 (or a lower dose on days 1-5 and 29-33). Within 4-8 weeks after completion of radio-chemotherapy, patients undergo surgical resection.
* Arm II: Patients undergo surgical resection. Patients are followed every 4 months for 2 years, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 380 patients (190 per treatment arm) will be accrued for this study within 3 years.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 195
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description CHIMIORADIOTHERAPIE SUIVIE DE CHIRURGIE conventional surgery CHIMIORADIOTHERAPIE SUIVIE DE CHIRURGIE CHIMIORADIOTHERAPIE SUIVIE DE CHIRURGIE neoadjuvant therapy CHIMIORADIOTHERAPIE SUIVIE DE CHIRURGIE CHIMIORADIOTHERAPIE SUIVIE DE CHIRURGIE radiation therapy CHIMIORADIOTHERAPIE SUIVIE DE CHIRURGIE CHIRURGIE SEULE conventional surgery CHIRURGIE SEULE CHIMIORADIOTHERAPIE SUIVIE DE CHIRURGIE cisplatin CHIMIORADIOTHERAPIE SUIVIE DE CHIRURGIE CHIMIORADIOTHERAPIE SUIVIE DE CHIRURGIE fluorouracil CHIMIORADIOTHERAPIE SUIVIE DE CHIRURGIE
- Primary Outcome Measures
Name Time Method overal survival 2010
- Secondary Outcome Measures
Name Time Method recurrence free survival 2010
Trial Locations
- Locations (71)
Institut Jules Bordet
🇧🇪Brussels, Belgium
Hopital Universitaire Erasme
🇧🇪Brussels, Belgium
Universitair Ziekenhuis Antwerpen
🇧🇪Edegem, Belgium
Universiteit Gent
🇧🇪Ghent, Belgium
Centre Paul Papin
🇫🇷Angers, France
CHR - Clinique Saint Joseph - Hopital de Warqueguies
🇧🇪Mons, Belgium
CHR de Besancon - Hopital Jean Minjoz
🇫🇷Besancon, France
CHU Ambroise Pare
🇫🇷Boulogne Billancourt, France
Centre Hospitalier Docteur Duchenne
🇫🇷Boulogne Sur Mer, France
Centre Hospitalier General
🇫🇷Brive, France
CHU Brest - Hopital De La Cavale Blanche
🇫🇷Brest, France
Clinique Sainte Marie
🇫🇷Chalon Sur Saone, France
Centre Hospitalier de Lagny
🇫🇷Compiegne, France
Centre Hospitalier Departemental
🇫🇷La Roche Sur Yon, France
Hopital Andre Mignot
🇫🇷Le Chesnay, France
Centre Jean Bernard
🇫🇷Le Mans, France
Polyclinique Du Bois
🇫🇷Lille, France
Centre Oscar Lambret
🇫🇷Lille, France
CHU de la Timone
🇫🇷Marseille, France
Hopital de la Croix Rousse
🇫🇷Lyon, France
Centre Hospitalier Regional et Universitaire de Lille
🇫🇷Lille, France
Assistance Publique Hopitaux de Marseille Hopitaux Sud
🇫🇷Marseille, France
Centre Gray
🇫🇷Maubeuge, France
Hopital Notre-Dame de Bon Secours
🇫🇷Metz, France
Centre Hospitalier de Meaux
🇫🇷Meaux, France
CH Meulan
🇫🇷Meulan-en-Yvelines, France
Centre Hospitalier
🇫🇷Mulhouse, France
CHR Hotel Dieu
🇫🇷Nantes, France
CHR D'Orleans - Hopital de la Source
🇫🇷Orleans, France
Hopital Europeen Georges Pompidou
🇫🇷Paris, France
Hopital Jean Bernard
🇫🇷Poitiers, France
Centre Rene Huguenin
🇫🇷Saint Cloud, France
C.H. Senlis
🇫🇷Senlis, France
Centre Paul Strauss
🇫🇷Strasbourg, France
CHU de Tours
🇫🇷Tours, France
Hopital Universitaire Hautepierre
🇫🇷Strasbourg, France
Nouvelle Clinique Generale
🇫🇷Valence, France
Centre Hospitalier de Valenciennes
🇫🇷Valenciennes, France
CHU de Nancy - Hopitaux de Brabois
🇫🇷Vandoeuvre-Les-Nancy, France
Centre d'Oncologie Saint-Yves
🇫🇷Vannes, France
Institut Gustave Roussy
🇫🇷Villejuif, France
Universitaet Erlangen
🇩🇪Erlangen, Germany
Universitaets-Krankenhaus Eppendorf
🇩🇪Hamburg, Germany
Klinikum der Albert - Ludwigs - Universitaet Freiburg
🇩🇪Freiburg, Germany
C.H. Bourg En Bresse
🇫🇷Bourg En Bresse, France
Institut J. Paoli and I. Calmettes
🇫🇷Marseille, France
Centre Hospitalier De Pontivy
🇫🇷Pontivy, France
Institut Jean Godinot
🇫🇷Reims, France
Centre Eugene Marquis
🇫🇷Rennes, France
Hopital Beaujon
🇫🇷Clichy, France
CHU de Caen
🇫🇷Caen, France
Hopital Louis Pasteur
🇫🇷Colmar, France
Centre Hospitalier Lyon Sud
🇫🇷Pierre Benite, France
Centre Hospitalier Regional et Universitaire d'Angers
🇫🇷Angers, France
CHR Clermont Ferrand, Hotel dieu
🇫🇷Clermont-Ferrand, France
Hopital Robert Boulin
🇫🇷Libourne, France
Centre Hospitalier Universitaire
🇫🇷Reims, France
Centre Hospitalier Intercommunal de Poissy
🇫🇷Saint Germain-en-Laye, France
Centre Hospitalier de Bourgoin - Jallieu
🇫🇷Bourgoin-Jallieu, France
Centre Hospitalier De Dunkerque - CHD
🇫🇷Dunkerque, France
Hopitaux Universitaire de Strasbourg
🇫🇷Strasbourg, France
Centre Hospitalier Universitaire de Dijon
🇫🇷Dijon, France
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
🇫🇷Montpellier, France
Hopital de l'Archet
🇫🇷Nice, France
Centre Hospitalier General De Saint-Malo
🇫🇷Saint-Malo, France
Hopital Saint Antoine
🇫🇷Paris, France
Centre Joliot Curie Des Docteurs Jean-Christophe Chardon Jacques Hernandez Et Laurent Gasnault
🇫🇷Saint Martin Boulogne, France
Centre Hospitalier D'Agen
🇫🇷St. Esprit, France
Clinique Sainte Clotilde
🇫🇷Sainte-Clotilde, France
Academisch Ziekenhuis Maastricht
🇳🇱Maastricht, Netherlands
Robert Roessle Comprehensive Cancer Center at University of Berlin - Charite Campus Buch
🇩🇪Berlin, Germany