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

March 27, 2020 updated by: Federation Francophone de Cancerologie Digestive

Randomized Study of Pre-Operative Radio-Chemotherapy Versus Surgery Alone in Thoracic Esophageal Cancer Deemed to be Resectable

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

195

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussels, Belgium, 1000
        • Institut Jules Bordet
      • Brussels, Belgium, 1070
        • Hopital Universitaire Erasme
      • Edegem, Belgium, B-2650
        • Universitair Ziekenhuis Antwerpen
      • Ghent, Belgium, B-9000
        • Universiteit Gent
      • Mons, Belgium, B-7000
        • CHR - Clinique Saint Joseph - Hopital de Warqueguies
  • France
      • Angers, France, 49033
        • Centre Hospitalier Regional et Universitaire d'Angers
      • Angers, France, 49036
        • Centre Paul Papin
      • Arras, France, 62000
      • Besancon, France, 25030
        • CHR de Besancon - Hopital Jean Minjoz
      • Boulogne Billancourt, France, F-92104
        • CHU Ambroise Pare
      • Boulogne Sur Mer, France, 62200
        • Centre Hospitalier Docteur Duchenne
      • Bourg En Bresse, France, 01012
        • C.H. Bourg En Bresse
      • Bourgoin-Jallieu, France, 38300
        • Centre Hospitalier de Bourgoin - Jallieu
      • Brest, France, 29200
        • CHU Brest - Hopital De La Cavale Blanche
      • Brive, France, 19101
        • Centre Hospitalier General
      • Caen, France, 14033
        • CHU de Caen
      • Chalon Sur Saone, France, 71100
        • Clinique Sainte Marie
      • Clermont-Ferrand, France, 63003
        • CHR Clermont Ferrand, Hotel Dieu
      • Clichy, France, 92118
        • Hopital Beaujon
      • Colmar, France, 68024
        • Hôpital Louis Pasteur
      • Compiegne, France, 60321
        • Centre Hospitalier de Lagny
      • Dijon, France, 21034
        • Centre Hospitalier Universitaire de Dijon
      • Dunkerque, France, 59240
        • Centre Hospitalier De Dunkerque - CHD
      • Evreux, France, 27000
      • La Roche Sur Yon, France, F-85025
        • Centre Hospitalier departemental
      • Le Chesnay, France, 78157
        • Hôpital André Mignot
      • Le Mans, France, 72000
        • Centre Jean Bernard
      • Libourne, France, 33500
        • Hôpital Robert Boulin
      • Lille, France, 59020
        • Centre Oscar Lambret
      • Lille, France, 59037
        • Centre Hospitalier Regional et Universitaire de Lille
      • Lille, France, 59000
        • Polyclinique Du Bois
      • Lyon, France, 69317
        • Hopital de la Croix Rousse
      • Marseille, France, 13385
        • CHU de la Timone
      • Marseille, France, 13273
        • Institut J. Paoli and I. Calmettes
      • Marseille, France, 13274
        • Assistance Publique Hopitaux de Marseille Hopitaux Sud
      • Maubeuge, France, 59600
        • Centre Gray
      • Meaux, France, 77104
        • Centre Hospitalier de Meaux
      • Metz, France, 57038
        • Hopital Notre-Dame de Bon Secours
      • Meulan-en-Yvelines, France, 78250
        • CH Meulan
      • Montpellier, France, 34298
        • Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
      • Mulhouse, France, 68070
        • Centre Hospitalier
      • Nantes, France, 44093
        • CHR Hotel Dieu
      • Nice, France, F-06202
        • Hopital de l'Archet
      • Orleans, France, 45067
        • CHR D'Orleans - Hopital de la Source
      • Paris, France, 75015
        • Hôpital Européen Georges Pompidou
      • Paris, France, 75012
        • Hopital Saint Antoine
      • Pierre Benite, France, 69495
        • Centre Hospitalier Lyon Sud
      • Poitiers, France, 86021
        • Hopital Jean Bernard
      • Pontivy, France, 56300
        • Centre Hospitalier De Pontivy
      • Reims, France, 51056
        • Institut Jean Godinot
      • Reims, France, 51092
        • Centre Hospitalier Universitaire
      • Rennes, France, 35042
        • Centre Eugène Marquis
      • Saint Cloud, France, 92210
        • Centre René Huguenin
      • Saint Germain-en-Laye, France, 78104
        • Centre Hospitalier Intercommunal de Poissy
      • Saint Martin Boulogne, France, 62280
        • Centre Joliot Curie Des Docteurs Jean-Christophe Chardon Jacques Hernandez Et Laurent Gasnault
      • Saint-Malo, France, 35400
        • Centre Hospitalier General De Saint-Malo
      • Sainte-Clotilde, France, 97400
        • Clinique Sainte Clotilde
      • Senlis, France, 60309
        • C.H. Senlis
      • St. Esprit, France, 47000
        • Centre Hospitalier d'Agen
      • Strasbourg, France, 67098
        • Hopital Universitaire Hautepierre
      • Strasbourg, France, 67065
        • Centre Paul Strauss
      • Strasbourg, France, 67091
        • Hopitaux Universitaire de Strasbourg
      • Tours, France, 37044
        • CHU de Tours
      • Valence, France, 26000
        • Nouvelle Clinique Generale
      • Valenciennes, France, 59300
        • Centre Hospitalier de Valenciennes
      • Vandoeuvre-Les-Nancy, France, 54511
        • CHU de Nancy - Hopitaux de Brabois
      • Vannes, France, 56001
        • Centre d'Oncologie Saint-Yves
      • Villejuif, France, F-94805
        • Institut Gustave Roussy
  • Germany
      • Berlin, Germany, D-13122
        • Robert Roessle Comprehensive Cancer Center at University of Berlin - Charite Campus Buch
      • Erlangen, Germany, D-91054
        • Universitaet Erlangen
      • Freiburg, Germany, D-79106
        • Klinikum der Albert - Ludwigs - Universitaet Freiburg
      • Hamburg, Germany, D-20246
        • Universitaets-Krankenhaus Eppendorf
  • Netherlands
      • Maastricht, Netherlands, 6202 AZ
        • Academisch Ziekenhuis Maastricht

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 74 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CHIMIORADIOTHERAPIE SUIVIE DE CHIRURGIE
Drug: fluorouracil
Radiation: radiation therapy
Procedure: neoadjuvant therapy
Drug: cisplatin
Procedure: conventional surgery
Active Comparator: CHIRURGIE SEULE
Procedure: conventional surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
overal survival
Time Frame: 2010
2010

Secondary Outcome Measures

Outcome Measure
Time Frame
recurrence free survival
Time Frame: 2010
2010

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federation Francophone de Cancerologie Digestive

Collaborators

European Organisation for Research and Treatment of Cancer - EORTC
UNICANCER
GERCOR - Multidisciplinary Oncology Cooperative Group
Societe Francaise de Radiotherapie Oncologique

Investigators

  • Study Chair: J. P. Triboulet, Centre Hospitalier Regional et Universitaire de Lille
  • Study Chair: Jean-Francois Seitz, MD, Institut Paoli-Calmettes

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2002

Primary Completion (Actual)

September 1, 2010

Study Completion (Actual)

September 1, 2010

Study Registration Dates

First Submitted

October 3, 2002

First Submitted That Met QC Criteria

January 26, 2003

First Posted (Estimate)

January 27, 2003

Study Record Updates

Last Update Posted (Actual)

March 30, 2020

Last Update Submitted That Met QC Criteria

March 27, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000257600
  • FFCD-9901
  • EORTC-22001
  • EORTC-40001
  • FRE-FNCLCC-FFCD-9901
  • FRE-GERCOR-FFCD-9901
  • SFRO-FFCD-9901
  • EU-20215

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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