Surgery With or Without Radiation Therapy and Chemotherapy in Treating Patients With Esophageal Cancer
NCT ID: NCT00047112
Last Updated: 2020-03-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
195 participants
INTERVENTIONAL
2002-05-31
2010-09-30
Brief Summary
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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.
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Detailed Description
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* 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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CHIMIORADIOTHERAPIE SUIVIE DE CHIRURGIE
CHIMIORADIOTHERAPIE SUIVIE DE CHIRURGIE
cisplatin
fluorouracil
conventional surgery
neoadjuvant therapy
radiation therapy
CHIRURGIE SEULE
CHIRURGIE SEULE
conventional surgery
Interventions
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cisplatin
fluorouracil
conventional surgery
neoadjuvant therapy
radiation therapy
Eligibility Criteria
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Inclusion Criteria
* 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
74 Years
ALL
No
Sponsors
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GERCOR - Multidisciplinary Oncology Cooperative Group
OTHER
European Organisation for Research and Treatment of Cancer - EORTC
NETWORK
UNICANCER
OTHER
Societe Francaise de Radiotherapie Oncologique
OTHER
Federation Francophone de Cancerologie Digestive
OTHER
Responsible Party
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Principal Investigators
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J. P. Triboulet
Role: STUDY_CHAIR
Centre Hospitalier Regional et Universitaire de Lille
Jean-Francois Seitz, MD
Role: STUDY_CHAIR
Institut Paoli-Calmettes
Locations
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Institut Jules Bordet
Brussels, , Belgium
Hopital Universitaire Erasme
Brussels, , Belgium
Universitair Ziekenhuis Antwerpen
Edegem, , Belgium
Universiteit Gent
Ghent, , Belgium
CHR - Clinique Saint Joseph - Hopital de Warqueguies
Mons, , Belgium
Centre Hospitalier Regional et Universitaire d'Angers
Angers, , France
Centre Paul Papin
Angers, , France
Arras, , France
CHR de Besancon - Hopital Jean Minjoz
Besançon, , France
CHU Ambroise Pare
Boulogne-Billancourt, , France
Centre Hospitalier Docteur Duchenne
Boulogne-sur-Mer, , France
C.H. Bourg En Bresse
Bourg-en-Bresse, , France
Centre Hospitalier de Bourgoin - Jallieu
Bourgoin, , France
CHU Brest - Hopital De La Cavale Blanche
Brest, , France
Centre Hospitalier General
Brivé, , France
CHU de Caen
Caen, , France
Clinique Sainte Marie
Chalon-sur-Saône, , France
CHR Clermont Ferrand, Hotel dieu
Clermont-Ferrand, , France
Hopital Beaujon
Clichy, , France
Hopital Louis Pasteur
Colmar, , France
Centre Hospitalier de Lagny
Compiègne, , France
Centre Hospitalier Universitaire de Dijon
Dijon, , France
Centre Hospitalier De Dunkerque - CHD
Dunkirk, , France
Évreux, , France
Centre Hospitalier Departemental
La Roche-sur-Yon, , France
Hopital Andre Mignot
Le Chesnay, , France
Centre Jean Bernard
Le Mans, , France
Hopital Robert Boulin
Libourne, , France
Polyclinique Du Bois
Lille, , France
Centre Oscar Lambret
Lille, , France
Centre Hospitalier Regional et Universitaire de Lille
Lille, , France
Hopital de la Croix Rousse
Lyon, , France
Institut J. Paoli and I. Calmettes
Marseille, , France
Assistance Publique Hopitaux de Marseille Hopitaux Sud
Marseille, , France
CHU de la Timone
Marseille, , France
Centre Gray
Maubeuge, , France
Centre Hospitalier de Meaux
Meaux, , France
Hopital Notre-Dame de Bon Secours
Metz, , France
CH Meulan
Meulan-en-Yvelines, , France
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
Montpellier, , France
Centre Hospitalier
Mulhouse, , France
CHR Hotel Dieu
Nantes, , France
Hopital de l'Archet
Nice, , France
CHR D'Orleans - Hopital de la Source
Orléans, , France
Hopital Saint Antoine
Paris, , France
Hopital Europeen Georges Pompidou
Paris, , France
Centre Hospitalier Lyon Sud
Pierre-Bénite, , France
Hopital Jean Bernard
Poitiers, , France
Centre Hospitalier De Pontivy
Pontivy, , France
Institut Jean Godinot
Reims, , France
Centre Hospitalier Universitaire
Reims, , France
Centre Eugene Marquis
Rennes, , France
Centre Rene Huguenin
Saint-Cloud, , France
Centre Hospitalier D'Agen
Saint-Esprit, , France
Centre Hospitalier Intercommunal de Poissy
Saint-Germain-en-Laye, , France
Centre Joliot Curie Des Docteurs Jean-Christophe Chardon Jacques Hernandez Et Laurent Gasnault
Saint-Martin-Boulogne, , France
Clinique Sainte Clotilde
Sainte-Clotilde, , France
C.H. Senlis
Senlis, , France
Centre Hospitalier General De Saint-Malo
St-Malo, , France
Centre Paul Strauss
Strasbourg, , France
Hopitaux Universitaire de Strasbourg
Strasbourg, , France
Hopital Universitaire Hautepierre
Strasbourg, , France
CHU de Tours
Tours, , France
Nouvelle Clinique Generale
Valence, , France
Centre Hospitalier de Valenciennes
Valenciennes, , France
CHU de Nancy - Hopitaux de Brabois
Vandœuvre-lès-Nancy, , France
Centre d'Oncologie Saint-Yves
Vannes, , France
Institut Gustave Roussy
Villejuif, , France
Robert Roessle Comprehensive Cancer Center at University of Berlin - Charite Campus Buch
Berlin, , Germany
Universitaet Erlangen
Erlangen, , Germany
Klinikum der Albert - Ludwigs - Universitaet Freiburg
Freiburg im Breisgau, , Germany
Universitaets-Krankenhaus Eppendorf
Hamburg, , Germany
Academisch Ziekenhuis Maastricht
Maastricht, , Netherlands
Countries
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References
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Mariette C, Robb WB, Piessen G. Reply to Letter: "The Role of Surgery for Patients With a Complete Clinical Response After Chemoradiation for Esophageal Cancer". Ann Surg. 2015 Dec;262(6):e101-2. doi: 10.1097/SLA.0000000000000668. No abstract available.
Mariette C, Dahan L, Mornex F, Maillard E, Thomas PA, Meunier B, Boige V, Pezet D, Robb WB, Le Brun-Ly V, Bosset JF, Mabrut JY, Triboulet JP, Bedenne L, Seitz JF. Surgery alone versus chemoradiotherapy followed by surgery for stage I and II esophageal cancer: final analysis of randomized controlled phase III trial FFCD 9901. J Clin Oncol. 2014 Aug 10;32(23):2416-22. doi: 10.1200/JCO.2013.53.6532. Epub 2014 Jun 30.
Robb WB, Dahan L, Mornex F, Maillard E, Thomas PA, Meunier B, Boige V, Pezet D, Le Brun-Ly V, Bosset JF, Mabrut JY, Triboulet JP, Bedenne L, Seitz JF, Mariette C; Federation Francaise de Cancerologie Digestive, Societe Francaise de Radiotherapie Oncologique, Union des Centres de Lutte Contre le Cancer, Groupe Cooperateur Multidisciplinaire en Oncologie, French EsoGAstric Tumour working group, Federation de Recherche En Chirurgie. Impact of neoadjuvant chemoradiation on lymph node status in esophageal cancer: post hoc analysis of a randomized controlled trial. Ann Surg. 2015 May;261(5):902-8. doi: 10.1097/SLA.0000000000000991.
Robb WB, Messager M, Dahan L, Mornex F, Maillard E, D'Journo XB, Triboulet JP, Bedenne L, Seitz JF, Mariette C; Federation Francophone de Cancerologie Digestive; Societe Francaise de Radiotherapie Oncologique; Union des Centres de Lutte Contre le Cancer; Groupe Cooperateur Multidisciplinaire en Oncologie; French EsoGAstric Tumour working group - Federation de Recherche En Chirurgie. Patterns of recurrence in early-stage oesophageal cancer after chemoradiotherapy and surgery compared with surgery alone. Br J Surg. 2016 Jan;103(1):117-25. doi: 10.1002/bjs.9959. Epub 2015 Oct 29.
Other Identifiers
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FFCD-9901
Identifier Type: -
Identifier Source: secondary_id
EORTC-22001
Identifier Type: -
Identifier Source: secondary_id
EORTC-40001
Identifier Type: -
Identifier Source: secondary_id
FRE-FNCLCC-FFCD-9901
Identifier Type: -
Identifier Source: secondary_id
FRE-GERCOR-FFCD-9901
Identifier Type: -
Identifier Source: secondary_id
SFRO-FFCD-9901
Identifier Type: -
Identifier Source: secondary_id
EU-20215
Identifier Type: -
Identifier Source: secondary_id
CDR0000257600
Identifier Type: -
Identifier Source: org_study_id
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