Surgery With or Without Radiation Therapy and Chemotherapy in Treating Patients With Esophageal Cancer - Full Text View

Sponsor:	Federation Francophone de Cancerologie Digestive
Collaborators:	Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR) European Organization for Research and Treatment of Cancer Federation Nationale des Centres de Lutte Contre le Cancer Societe Francaise de Radiotherapie Oncologique
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00047112

Purpose

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.

Condition	Intervention	Phase
Esophageal Cancer	Drug: cisplatin Drug: fluorouracil Procedure: conventional surgery Procedure: neoadjuvant therapy Radiation: radiation therapy	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control
Official Title:	Randomized Study of Pre-Operative Radio-Chemotherapy Versus Surgery Alone in Thoracic Esophageal Cancer Deemed to be Resectable

Resource links provided by NLM:

MedlinePlus related topics: Cancer Esophageal Cancer Esophagus Disorders Surgery

Drug Information available for: Fluorouracil Cisplatin

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:

May 2002

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.

Eligibility

Ages Eligible for Study:	up to 74 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00047112

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Locations

Belgium
CHR - Clinique Saint Joseph - Hopital de Warqueguies
Mons, Belgium, B-7000
Hopital Universitaire Erasme
Brussels, Belgium, 1070
Institut Jules Bordet
Brussels, Belgium, 1000
Universitair Ziekenhuis Antwerpen
Edegem, Belgium, B-2650
Universiteit Gent
Ghent, Belgium, B-9000
France

Evreux, France, 27000
Assistance Publique Hopitaux de Marseille Hopitaux Sud
Marseille, France, 13274
C.H. Bourg En Bresse
Bourg En Bresse, France, 01012
C.H. Senlis
Senlis, France, 60309
Centre d'Oncologie Saint-Yves
Vannes, France, 56001
Centre Eugene Marquis
Rennes, France, 35042
Centre Gray
Maubeuge, France, 59600
Centre Hospitalier D'Agen
St. Esprit, France, 47000
Centre Hospitalier de Bourgoin - Jallieu
Bourgoin-Jallieu, France, 38300
Centre Hospitalier De Dunkerque - CHD
Dunkerque, France, 59240
Centre Hospitalier de Lagny
Compiegne, France, 60321
Centre Hospitalier de Meaux
Meaux, France, 77104
Centre Hospitalier De Pontivy
Pontivy, France, 56300
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
Montpellier, France, 34298
Centre Hospitalier Departemental
La Roche Sur Yon, France, F-85025
Centre Hospitalier Docteur Duchenne
Boulogne Sur Mer, France, 62200
Centre Hospitalier General De Saint-Malo
Saint-Malo, France, 35400
Centre Hospitalier General
Brive, France, 19101
Centre Hospitalier Intercommunal de Poissy
Saint Germain-en-Laye, France, 78104
Centre Hospitalier Lyon Sud
Pierre Benite, France, 69495
Centre Hospitalier Regional et Universitaire d'Angers
Angers, France, 49033
Centre Hospitalier Regional et Universitaire de Lille
Lille, France, 59037
Centre Hospitalier Universitaire de Dijon
Dijon, France, 21034
Centre Hospitalier Universitaire
Reims, France, 51092
Centre Hospitalier
Mulhouse, France, 68070
Centre Jean Bernard
Le Mans, France, 72000
Centre Joliot Curie Des Docteurs Jean-Christophe Chardon Jacques Hernandez Et Laurent Gasnault
Saint Martin Boulogne, France, 62280
Centre Oscar Lambret
Lille, France, 59020
Centre Paul Papin
Angers, France, 49036
Centre Paul Strauss
Strasbourg, France, 67065
Centre Hospitalier de Valenciennes
Valenciennes, France, 59300
Centre Rene Huguenin
Saint Cloud, France, 92210
CH Meulan
Meulan, France, 78250
CHR Clermont Ferrand, Hotel dieu
Clermont-Ferrand, France, 63003
CHR de Besancon - Hopital Jean Minjoz
Besancon, France, 25030
CHR D'Orleans - Hopital de la Source
Orleans, France, 45067
CHR Hotel Dieu
Nantes, France, 44093
CHU Ambroise Pare
Boulogne Billancourt, France, F-92104
CHU Brest - Hopital De La Cavale Blanche
Brest, France, 29200
CHU de Caen
Caen, France, 14033
CHU de la Timone
Marseille, France, 13385
Hopital Europeen Georges Pompidou
Paris, France, 75015
CHU de Tours
Tours, France, 37044
Clinique Sainte Clotilde
Sainte Clotilde, France, 97492
Clinique Sainte Marie
Chalon Sur Saone, France, 71100
Hopital Andre Mignot
Le Chesnay, France, 78157
Hopital Beaujon
Clichy, France, 92118
Hopital de la Croix Rousse
Lyon, France, 69317
Hopital de l'Archet
Nice, France, F-06202
CHU de Nancy - Hopitaux de Brabois
Vandoeuvre-Les-Nancy, France, 54511
Hopital Jean Bernard
Poitiers, France, 86021
Hopital Louis Pasteur
Colmar, France, 68024
Hopital Notre-Dame de Bon Secours
Metz, France, 57038
Hopital Robert Boulin
Libourne, France, 33500
Hopital Saint Antoine
Paris, France, 75012
Institut J. Paoli and I. Calmettes
Marseille, France, 13273
Hopitaux Universitaire de Strasbourg
Strasbourg, France, 67091
Institut Gustave Roussy
Villejuif, France, F-94805
Hopital Universitaire Hautepierre
Strasbourg, France, 67098
Institut Jean Godinot
Reims, France, 51056

Arras, France, 62000
Nouvelle Clinique Generale
Valence, France, 26000
Polyclinique Du Bois
Lille, France, 59000
Germany
Klinikum der Albert - Ludwigs - Universitaet Freiburg
Freiburg, Germany, D-79106
Robert Roessle Comprehensive Cancer Center at University of Berlin - Charite Campus Buch
Berlin, Germany, D-13122
Universitaet Erlangen
Erlangen, Germany, D-91054
Universitaets-Krankenhaus Eppendorf
Hamburg, Germany, D-20246
Netherlands
Academisch Ziekenhuis Maastricht
Maastricht, Netherlands, 6202 AZ

Sponsors and Collaborators

Federation Francophone de Cancerologie Digestive

Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR)

European Organization for Research and Treatment of Cancer

Federation Nationale des Centres de Lutte Contre le Cancer

Societe Francaise de Radiotherapie Oncologique

Investigators

Study Chair:	J. P. Triboulet	Centre Hospitalier Regional et Universitaire de Lille
Study Chair:	Gerard Ganem, MD	Centre Jean Bernard
Investigator:	Jean-Francois Bosset, MD	Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz
Investigator:	Thierry Conroy, MD	Centre Alexis Vautrin
Study Chair:	Jean-Francois Seitz, MD	Institut Paoli-Calmettes
Study Chair:	Francoise Mornex, MD, PhD	Centre Hospitalier Lyon Sud

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000257600, FFCD-9901, EORTC-22001, EORTC-40001, FRE-FNCLCC-FFCD-9901, FRE-GERCOR-FFCD-9901, SFRO-FFCD-9901, EU-20215
Study First Received:	October 3, 2002
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00047112 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

adenocarcinoma of the esophagus
squamous cell carcinoma of the esophagus
stage I esophageal cancer
stage II esophageal cancer

Additional relevant MeSH terms:

Antimetabolites
Antimetabolites, Antineoplastic
Digestive System Neoplasms
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Diseases
Antineoplastic Agents
Esophageal Neoplasms
Physiological Effects of Drugs
Immunosuppressive Agents
Pharmacologic Actions

Neoplasms
Digestive System Diseases
Neoplasms by Site
Radiation-Sensitizing Agents
Cisplatin
Head and Neck Neoplasms
Fluorouracil
Therapeutic Uses
Gastrointestinal Neoplasms
Esophageal Diseases

ClinicalTrials.gov processed this record on November 25, 2009