Surgery With or Without Radiation Therapy and Chemotherapy in Treating Patients With Esophageal Cancer

NCT00047112 | Completed Phase 3

• 8 other identifiers: CDR0000257600FFCD-9901EORTC-22001EORTC-40001FRE-FNCLCC-FFCD-9901FRE-GERCOR-FFCD-9901SFRO-FFCD-9901EU-20215
• Study Type: interventional
• Target: 195
• Locations: 4 countries
• Sites: 73

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.

Conditions

Esophageal Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• overal survival

  2010

Secondary Outcomes (1)

• recurrence free survival

  2010

Study Arms (2)

CHIMIORADIOTHERAPIE SUIVIE DE CHIRURGIE

EXPERIMENTAL

CHIMIORADIOTHERAPIE SUIVIE DE CHIRURGIE

Drug: cisplatin; Drug: fluorouracil; Procedure: conventional surgery; Procedure: neoadjuvant therapy; Radiation: radiation therapy

CHIRURGIE SEULE

ACTIVE COMPARATOR

CHIRURGIE SEULE

Procedure: conventional surgery

Interventions

cisplatin DRUG

CHIMIORADIOTHERAPIE SUIVIE DE CHIRURGIE

fluorouracil DRUG

CHIMIORADIOTHERAPIE SUIVIE DE CHIRURGIE

conventional surgery PROCEDURE

CHIMIORADIOTHERAPIE SUIVIE DE CHIRURGIE; CHIRURGIE SEULE

neoadjuvant therapy PROCEDURE

CHIMIORADIOTHERAPIE SUIVIE DE CHIRURGIE

radiation therapy RADIATION

CHIMIORADIOTHERAPIE SUIVIE DE CHIRURGIE

Eligibility Criteria

• Age: Up to 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Federation Francophone de Cancerologie Digestive: lead
• GERCOR - Multidisciplinary Oncology Cooperative Group: collaborator
• European Organisation for Research and Treatment of Cancer - EORTC: collaborator
• UNICANCER: collaborator
• Societe Francaise de Radiotherapie Oncologique: collaborator

Study Sites (73)

Institut Jules Bordet

Brussels, 1000, Belgium

Location

Hopital Universitaire Erasme

Brussels, 1070, Belgium

Location

Universitair Ziekenhuis Antwerpen

Edegem, B-2650, Belgium

Location

Universiteit Gent

Ghent, B-9000, Belgium

Location

CHR - Clinique Saint Joseph - Hopital de Warqueguies

Mons, B-7000, Belgium

Location

Centre Hospitalier Regional et Universitaire d'Angers

Angers, 49033, France

Location

Centre Paul Papin

Angers, 49036, France

Location

Unknown Facility

Arras, 62000, France

Location

CHR de Besancon - Hopital Jean Minjoz

Besançon, 25030, France

Location

CHU Ambroise Pare

Boulogne-Billancourt, F-92104, France

Location

Centre Hospitalier Docteur Duchenne

Boulogne-sur-Mer, 62200, France

Location

C.H. Bourg En Bresse

Bourg-en-Bresse, 01012, France

Location

Centre Hospitalier de Bourgoin - Jallieu

Bourgoin, 38300, France

Location

CHU Brest - Hopital De La Cavale Blanche

Brest, 29200, France

Location

Centre Hospitalier General

Brivé, 19101, France

Location

CHU de Caen

Caen, 14033, France

Location

Clinique Sainte Marie

Chalon-sur-Saône, 71100, France

Location

CHR Clermont Ferrand, Hotel dieu

Clermont-Ferrand, 63003, France

Location

Hopital Beaujon

Clichy, 92118, France

Location

Hopital Louis Pasteur

Colmar, 68024, France

Location

Centre Hospitalier de Lagny

Compiègne, 60321, France

Location

Centre Hospitalier Universitaire de Dijon

Dijon, 21034, France

Location

Centre Hospitalier De Dunkerque - CHD

Dunkirk, 59240, France

Location

Unknown Facility

Évreux, 27000, France

Location

Centre Hospitalier Departemental

La Roche-sur-Yon, F-85025, France

Location

Hopital Andre Mignot

Le Chesnay, 78157, France

Location

Centre Jean Bernard

Le Mans, 72000, France

Location

Hopital Robert Boulin

Libourne, 33500, France

Location

Polyclinique Du Bois

Lille, 59000, France

Location

Centre Oscar Lambret

Lille, 59020, France

Location

Centre Hospitalier Regional et Universitaire de Lille

Lille, 59037, France

Location

Hopital de la Croix Rousse

Lyon, 69317, France

Location

Institut J. Paoli and I. Calmettes

Marseille, 13273, France

Location

Assistance Publique Hopitaux de Marseille Hopitaux Sud

Marseille, 13274, France

Location

CHU de la Timone

Marseille, 13385, France

Location

Centre Gray

Maubeuge, 59600, France

Location

Centre Hospitalier de Meaux

Meaux, 77104, France

Location

Hopital Notre-Dame de Bon Secours

Metz, 57038, France

Location

CH Meulan

Meulan-en-Yvelines, 78250, France

Location

Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle

Montpellier, 34298, France

Location

Centre Hospitalier

Mulhouse, 68070, France

Location

CHR Hotel Dieu

Nantes, 44093, France

Location

Hopital de l'Archet

Nice, F-06202, France

Location

CHR D'Orleans - Hopital de la Source

Orléans, 45067, France

Location

Hopital Saint Antoine

Paris, 75012, France

Location

Hopital Europeen Georges Pompidou

Paris, 75015, France

Location

Centre Hospitalier Lyon Sud

Pierre-Bénite, 69495, France

Location

Hopital Jean Bernard

Poitiers, 86021, France

Location

Centre Hospitalier De Pontivy

Pontivy, 56300, France

Location

Institut Jean Godinot

Reims, 51056, France

Location

Centre Hospitalier Universitaire

Reims, 51092, France

Location

Centre Eugene Marquis

Rennes, 35042, France

Location

Centre Rene Huguenin

Saint-Cloud, 92210, France

Location

Centre Hospitalier D'Agen

Saint-Esprit, 47000, France

Location

Centre Hospitalier Intercommunal de Poissy

Saint-Germain-en-Laye, 78104, France

Location

Centre Joliot Curie Des Docteurs Jean-Christophe Chardon Jacques Hernandez Et Laurent Gasnault

Saint-Martin-Boulogne, 62280, France

Location

Clinique Sainte Clotilde

Sainte-Clotilde, 97400, France

Location

C.H. Senlis

Senlis, 60309, France

Location

Centre Hospitalier General De Saint-Malo

St-Malo, 35400, France

Location

Centre Paul Strauss

Strasbourg, 67065, France

Location

Hopitaux Universitaire de Strasbourg

Strasbourg, 67091, France

Location

Hopital Universitaire Hautepierre

Strasbourg, 67098, France

Location

CHU de Tours

Tours, 37044, France

Location

Nouvelle Clinique Generale

Valence, 26000, France

Location

Centre Hospitalier de Valenciennes

Valenciennes, 59300, France

Location

CHU de Nancy - Hopitaux de Brabois

Vandœuvre-lès-Nancy, 54511, France

Location

Centre d'Oncologie Saint-Yves

Vannes, 56001, France

Location

Institut Gustave Roussy

Villejuif, F-94805, France

Location

Robert Roessle Comprehensive Cancer Center at University of Berlin - Charite Campus Buch

Berlin, D-13122, Germany

Location

Universitaet Erlangen

Erlangen, D-91054, Germany

Location

Klinikum der Albert - Ludwigs - Universitaet Freiburg

Freiburg im Breisgau, D-79106, Germany

Location

Universitaets-Krankenhaus Eppendorf

Hamburg, D-20246, Germany

Location

Academisch Ziekenhuis Maastricht

Maastricht, 6202 AZ, Netherlands

Location

Related Publications (4)

• 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.

  PMID: 24670853 BACKGROUND

• 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.

  PMID: 24982463 RESULT

• 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.

  PMID: 25361220 RESULT

• 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.

  PMID: 26511668 DERIVED

MeSH Terms

Conditions

Esophageal Neoplasms; Adenocarcinoma Of Esophagus; Esophageal Squamous Cell Carcinoma

Interventions

Cisplatin; Fluorouracil; Neoadjuvant Therapy; Radiotherapy

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms, Squamous Cell

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Combined Modality Therapy; Therapeutics

Study Officials

• J. P. Triboulet

  Centre Hospitalier Regional et Universitaire de Lille

  STUDY CHAIR

• Jean-Francois Seitz, MD

  Institut Paoli-Calmettes

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 3, 2002
• First Posted: January 27, 2003
• Study Start: May 1, 2002
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: March 30, 2020

Record last verified: 2020-03

Locations

FR (63); NL (1); BE (5); DE (4)