Surgery With or Without Radiation Therapy and Chemotherapy in Treating Patients With Esophageal Cancer
Esophageal Cancer
About this trial
This is an interventional treatment trial for Esophageal Cancer focused on measuring adenocarcinoma of the esophagus, squamous cell carcinoma of the esophagus, stage I esophageal cancer, stage II esophageal cancer
Eligibility Criteria
DISEASE CHARACTERISTICS: Diagnosis of stage I or II thoracic esophageal cancer Tumor no greater than 3 cm with no invasion of mediastinal structures with or without extension to the lymph nodes (T1-2, N0-1, M0) OR Tumor greater than 3 cm with no invasion of mediastinal structures and no adenopathy greater than 1 cm (T3, N0, M0) Epidermoid carcinoma or adenocarcinoma Previously untreated Deemed resectable with curative intent No carcinoma in situ No small cell anaplastic carcinoma (i.e., chromogranin negative) No small cell neuroendocrine carcinoma (i.e., chromogranin positive) No multifocal esophageal carcinoma (i.e., 2 or more distinct lesions 5 or more cm apart) No involvement of the pharyngoesophageal junction and the first 4 cm of the esophagus (i.e., where the proximal edge of the tumor is less than 19 cm from the dental arch) No evidence of extension to the tracheobronchial tree at endoscopy, ultrasound, or CT scan (simple compression allowed) No signs of mediastinal involvement on CT scan No palpable subclavicular lymph nodes or involvement after cytology needle aspiration No lymph nodes from the origin of the celiac greater than 1 cm on CT scan Perigastric lymph nodes far from the celiac trunk and deemed resectable allowed unless tumor is more than 30 mm on CT scan PATIENT CHARACTERISTICS: Age Under 75 Performance status WHO 0-1 Life expectancy Not specified Hematopoietic Granulocyte count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Hepatic SGOT/SGPT ratio no greater than 1 Albumin at least 35 g/L Total protein greater than 80% No liver cirrhosis with previous failure No ascites No jaundice No rupture of varicose esophageal veins No presence of varicose esophageal veins Renal Creatinine no greater than 1.25 times normal Cardiovascular Arterial O_2 greater than 60 mm Hg Arterial CO_2 no greater than 45 mm Hg No myocardial infarction within the past 6 months No progressive coronary artery disease grade 2 or greater No recent left ventricular failure No arterial disease stage II-IV Pulmonary FEV_1 greater than 1 L/sec Other Able to receive either study treatment No recurrent paralysis No weight loss greater than 10% from baseline No other prior or concurrent malignancy except basal cell skin cancer or carcinoma in situ of the cervix Not pregnant Fertile patients must use effective contraception during and for 3 months after completion of chemotherapy PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy Not specified Endocrine therapy Not specified Radiotherapy Not specified Surgery Not specified
Sites / Locations
- Institut Jules Bordet
- Hopital Universitaire Erasme
- Universitair Ziekenhuis Antwerpen
- Universiteit Gent
- CHR - Clinique Saint Joseph - Hopital de Warqueguies
- Centre Hospitalier Regional et Universitaire d'Angers
- Centre Paul Papin
- CHR de Besancon - Hopital Jean Minjoz
- CHU Ambroise Pare
- Centre Hospitalier Docteur Duchenne
- C.H. Bourg En Bresse
- Centre Hospitalier de Bourgoin - Jallieu
- CHU Brest - Hopital De La Cavale Blanche
- Centre Hospitalier General
- CHU de Caen
- Clinique Sainte Marie
- CHR Clermont Ferrand, Hotel dieu
- Hopital Beaujon
- Hopital Louis Pasteur
- Centre Hospitalier de Lagny
- Centre Hospitalier Universitaire de Dijon
- Centre Hospitalier De Dunkerque - CHD
- Centre Hospitalier Departemental
- Hopital Andre Mignot
- Centre Jean Bernard
- Hopital Robert Boulin
- Polyclinique Du Bois
- Centre Oscar Lambret
- Centre Hospitalier Regional et Universitaire de Lille
- Hopital de la Croix Rousse
- Institut J. Paoli and I. Calmettes
- Assistance Publique Hopitaux de Marseille Hopitaux Sud
- CHU de la Timone
- Centre Gray
- Centre Hospitalier de Meaux
- Hopital Notre-Dame de Bon Secours
- CH Meulan
- Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
- Centre Hospitalier
- CHR Hotel Dieu
- Hopital de l'Archet
- CHR D'Orleans - Hopital de la Source
- Hopital Saint Antoine
- Hopital Europeen Georges Pompidou
- Centre Hospitalier Lyon Sud
- Hopital Jean Bernard
- Centre Hospitalier De Pontivy
- Institut Jean Godinot
- Centre Hospitalier Universitaire
- Centre Eugene Marquis
- Centre Rene Huguenin
- Centre Hospitalier Intercommunal de Poissy
- Centre Joliot Curie Des Docteurs Jean-Christophe Chardon Jacques Hernandez Et Laurent Gasnault
- Centre Hospitalier General De Saint-Malo
- Clinique Sainte Clotilde
- C.H. Senlis
- Centre Hospitalier D'Agen
- Centre Paul Strauss
- Hopitaux Universitaire de Strasbourg
- Hopital Universitaire Hautepierre
- CHU de Tours
- Nouvelle Clinique Generale
- Centre Hospitalier de Valenciennes
- CHU de Nancy - Hopitaux de Brabois
- Centre d'Oncologie Saint-Yves
- Institut Gustave Roussy
- Robert Roessle Comprehensive Cancer Center at University of Berlin - Charite Campus Buch
- Universitaet Erlangen
- Klinikum der Albert - Ludwigs - Universitaet Freiburg
- Universitaets-Krankenhaus Eppendorf
- Academisch Ziekenhuis Maastricht
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
CHIMIORADIOTHERAPIE SUIVIE DE CHIRURGIE
CHIRURGIE SEULE
CHIMIORADIOTHERAPIE SUIVIE DE CHIRURGIE
CHIRURGIE SEULE