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Surgery With or Without Radiation Therapy and Chemotherapy in Treating Patients With Esophageal Cancer Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment by using a genuine medical doctor. We aren't mDs. Always confer with your doctor on Surgery With or Without Radiation Therapy and Chemotherapy in Treating Patients With Esophageal Cancer conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. Surgery With or Without Radiation Therapy and Chemotherapy in Treating Patients With Esophageal Cancer Clinical research trials and Surgery With or Without Radiation Therapy and Chemotherapy in Treating Patients With Esophageal Cancer healthcare trials occur in a lot of of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectivity of new does drugs. The role of the studies / undertakings is to solve specific human healthcare questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to find treatments for all kinds of conditions, including Surgery With or Without Radiation Therapy and Chemotherapy in Treating Patients With Esophageal Cancer. Surgery With or Without Radiation Therapy and Chemotherapy in Treating Patients With Esophageal Cancer Clinical Trials and other clinical trials allow for volunteers to access health treatment choices before they are available to the general public. Many times the test subjects get treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a Surgery With or Without Radiation Therapy and Chemotherapy in Treating Patients With Esophageal Cancer clinical trial. Test subjects typically receive the most effective healthcare possible for their Surgery With or Without Radiation Therapy and Chemotherapy in Treating Patients With Esophageal Cancer condition. Risks are a reality, nonetheless, and could include extra or frequent dr. calls, health hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
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Home > "S" Clinical Trials Conditions > Surgery With or Without Radiation Therapy and Chemotherapy in Treating Patients With Esophageal Cancer  Surgery With or Without Radiation Therapy and Chemotherapy in Treating Patients With Esophageal Cancer
Surgery With or Without Radiation Therapy and Chemotherapy in Treating Patients With Esophageal Cancer
For Condition: stage 1 esophageal cancer,stage 2 esophageal cancer,Adenocarcinoma of the Esophagus,squamous cell carcinoma of the esophagus
Status: Recruiting
Sponsor(s): Federation Francophone de Cancerologie Digestive , GERCOR,EORTC Radiotherapy Cooperative Group,EORTC Gastrointestinal Tract Cancer Cooperative Group,Federation Nationale des Centres de Lutte Contre le Cancer,Societe Francaise de Radiotherapie Oncologique
Synopsis: 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: Randomizedphase III trial to compare the effectiveness of surgery with or without radiation therapy and chemotherapy in treating patients who have esophageal cancer.
Details: 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:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /74 Years
Genders: Both
Protocol Entry 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
JeanBosset, , CHR de Besancon - Hopital Jean Minjoz
Universitair Ziekenhuis Antwerpen *Recruiting*
Edegem, , B-2650
Belgium
Recruiting Contact Person 32-3-821-3000
CHR Hotel Dieu *Recruiting*
Nantes, , 44093
France
Recruiting Herve Lacroix 33-2-4008-3151
Centre Hospitalier Universitaire *Recruiting*
Reims, , 51092
France
Recruiting O. Bouche 33-3-2678-7170
Centre Joliot Curie Des Docteurs Jean-Christophe Chardon Jacques Hernandez Et Laurent Gasnault *Recruiting*
Saint-Martin-Boulogne, , 62280
France
Recruiting Jean-Christophe Chardon 33-3-2131-2020
Centre Hospitalier de Valenciennes *Recruiting*
Valenciennes, , 59300
France
Recruiting Jean-Francois Minne 33-3-2714-7500
CHR de Besancon - Hopital Jean Minjoz *Recruiting*
Besancon, , 25030
France
Recruiting Jean Bosset 33-3-81-66-8310
Centre Hospitalier De Dunkerque - CHD *Recruiting*
Dunkerque, , 59240
France
Recruiting Fivos Economides 33-3-2851-9630
Centre Hospitalier de Lagny *Recruiting*
Compiegne, , 60321
France
Recruiting Marc Faraldi 33-3-4423-6378
Hopital Andre Mignot *Recruiting*
Le Chesnay, , 78157
France
Recruiting Roderich Meckenstock 33-01-3963-8909
Centre Hospitalier General *Recruiting*
Brive, , 19101
France
Recruiting Bernard Leduc 33-5-55-92-6670
CHU Brest - Hopital De La Cavale Blanche *Recruiting*
Brest, , 29200
France
Recruiting Patrick Lozach 33-2-9831-7224
CH Meulan *Recruiting*
Meulan, , 78250
France
Recruiting Leroy-Terquem 33-1-3022-4137
C.H. Bourg En Bresse *Recruiting*
Bourg-en-Bresse, , 01012
France
Recruiting Danielle Langeron 33-4-7445-4327
Centre Hospitalier Departemental *Recruiting*
La Roche-sur-Yon, , F-85025
France
Recruiting Ayman Zawadi 33-2-5144-6317
Centre d'Oncologie Saint-Yves *Recruiting*
Vannes, , 56001
France
Recruiting Vincent Klein 33-2-9746-6681
Centre Hospitalier Universitaire de Dijon *Recruiting*
Dijon, , 21034
France
Recruiting Laurent Bedenne 33-380-293-750
Institut J. Paoli and I. Calmettes *Recruiting*
Marseille, , 13273
France
Recruiting Jean Seitz 33-4-9122-3302
Centre Hospitalier *Recruiting*
Mulhouse, , 68070
France
Recruiting Vedrenne 33-3-8964-7049
CHU de Tours *Recruiting*
Tours, , 37044
France
Recruiting de Calan 33-2-4747-4747
Institut Jean Godinot *Recruiting*
Reims, , 51056
France
Recruiting Tan Nguyen 33-3-2678-7170
CHU de Caen *Recruiting*
Caen, , 14033
France
Recruiting Jean Maurel 33-2-31-06-4470
Assistance Publique Hopitaux de Marseille Hopitaux Sud *Recruiting*
Marseille, , 13274
France
Recruiting Pascal Thomas 33-4-9174-4680
Centre Hospitalier de Bourgoin - Jallieu *Recruiting*
Bourgoin-Jallieu, , 38300
France
Recruiting Noel Stremsdoerfer 33-4-7427-3011
Centre Rene Huguenin *Recruiting*
Saint Cloud, , 92210
France
Recruiting Frederique Bertheault-Cvitkovic 33-1-4711-1515
CHR Clermont Ferrand, Hotel dieu *Recruiting*
Clermont-Ferrand, , 63003
France
Recruiting Gilles Bommelaer 33-47-375-0523
CHU de Nancy - Hopitaux de Brabois *Recruiting*
Vandoeuvre-les-Nancy, , 54511
France
Recruiting Patrick Boissel 33-3-83-15-31-20
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle *Recruiting*
Montpellier, , 34298
France
Recruiting Marc Ychou 33-4-6761-3066
Centre Hospitalier Docteur Duchenne *Recruiting*
Boulogne-sur-Mer, , 62200
France
Recruiting Jacky Charneau 33-3-21-99-3333
Centre Hospitalier Intercommunal de Poissy *Recruiting*
Saint-Germain-en-Laye, , 78104
France
Recruiting Benchalal 33-1-3927-5243
CHU Ambroise Pare *Recruiting*
Boulogne-Billancourt, , F-92104
France
Recruiting Philippe Rougier 33-1-4909-5878
Hopital Louis Pasteur *Recruiting*
Colmar, , 68024
France
Recruiting Bernard Denis 33-3-8912-4000
Hopital Jean Bernard *Recruiting*
Poitiers, , 86021
France
Recruiting Jean-Marc Tourani 33-5-4944-4489
Hopital Universitaire Erasme *Recruiting*
Brussels, , 1070
Belgium
Recruiting Contact Person 32-2-555-3111
Hopitaux Universitaire de Strasbourg *Recruiting*
Strasbourg, , 67091
France
Recruiting Wilns 33-3-3811-6768
Hopital de l'Archet *Recruiting*
Nice, , F-06202
France
Recruiting Francois Caroli-Bosc 33-4-9203-6021
Hopital Saint Antoine *Recruiting*
Paris, , 75012
France
Recruiting Emmanuel Tiret 33-1-4928-2563
Centre Hospitalier Lyon Sud *Recruiting*
Pierre-Benite, , 69495
France
Recruiting Francoise Mornex 33-4-7886-1681
Hopital Europeen Georges Pompidou *Recruiting*
Paris, , 75015
France
Recruiting Bruno Landi 33-14-4398-6810
Centre Hospitalier Regional et Universitaire d'Angers *Recruiting*
Angers, , 49033
France
Recruiting Jean-Pierre Arnaud 33-2-41-35-3618
Hopital Robert Boulin *Recruiting*
Libourne, , 33500
France
Recruiting Dominique Auby 33-05-5755-3552
Centre Paul Papin *Recruiting*
Angers, , 49036
France
Recruiting Erick Gamelin 33-2-41-35-2700
CHU de la Timone *Recruiting*
Marseille, , 13385
France
Recruiting Jean Seitz 33-4-9138-6023
Clinique Sainte Clotilde *Recruiting*
Sainte Clotilde, , 97492
France
Recruiting Regis Soleilhac 33-2-62-48-2040
Hopital de la Croix Rousse *Recruiting*
Lyon, , 69317
France
Recruiting Jacques Baulieux 0472071625
Centre Eugene Marquis *Recruiting*
Rennes, , 35042
France
Recruiting B. Meunier 33-2-9925-3196
Centre Hospitalier D'Agen *Recruiting*
St. Esprit, , 47000
France
Recruiting Jean-Claude Tissot 33-5-5369-7060
Hopital Beaujon *Recruiting*
Clichy, , 92118
France
Recruiting J. Belghiti 33-1-40-875248
Hopital Universitaire Hautepierre *Recruiting*
Strasbourg, , 67098
France
Recruiting Marc-Etienne Meyer 33-3-8812-7236
Institut Gustave Roussy *Recruiting*
Villejuif, , F-94805
France
Recruiting Michel Ducreux 33-1-4211-4308
Institut Jules Bordet *Recruiting*
Brussels, , 1000
Belgium
Recruiting Contact Person 32-2-541-3111
Centre Alexis Vautrin *Recruiting*
Vandoeuvre-les-Nancy, , 54511
France
Recruiting Contact Person 33-03-8315-3119
Centre Gray *Recruiting*
Maubeuge, , 59600
France
Recruiting Pascal Meyer 33-32-769-8383
Polyclinique Du Bois *Recruiting*
Lille, , 59000
France
Recruiting Crinquette 33-3-2022-5600
Hopital Notre-Dame de Bon Secours *Recruiting*
Metz, , 57038
France
Recruiting Christian Platini 33-3-8255-8128
Centre Paul Strauss *Recruiting*
Strasbourg, , 67065
France
Recruiting Pierre Haegele 33-3-8825-2485
Universitaets-Krankenhaus Eppendorf *Recruiting*
Hamburg, , D-20246
Germany
Recruiting Contact Person 49-40-428-030
Centre Hospitalier Regional et Universitaire de Lille *Recruiting*
Lille, , 59037
France
Recruiting J. Triboulet 33-3-20-44-42-04
Akademisch Ziekenhuis Gent *Recruiting*
Gent, , B-9000
Belgium
Recruiting Contact Person 32-9-240-2138
Centre Jean Bernard *Recruiting*
Le Mans, , 72000
France
Recruiting Gerard Ganem 334-339-1300
Clinique Generale *Recruiting*
Valence, , 26000
France
Recruiting Remi Mackiewicz 33-4-7575-6666
Centre Hospitalier de Meaux *Recruiting*
Meaux, , 77104
France
Recruiting Glikmanas 33-1-6435-3854
Clinique Sainte Marie *Recruiting*
Chalon-sur-Saone, , 71100
France
Recruiting Jean-Philippe Herr 33-3-85-47-6182
Centre Hospitalier De Pontivy *Recruiting*
Pontivy, , 56300
France
Recruiting Jacques-Arnaud Seyrig 33-2-9728-4048
C.H. Senlis *Recruiting*
Senlis, , 60309
France
Recruiting Elisabeth Carola 33-3-4421-7026
Centre Oscar Lambret *Recruiting*
Lille, , 59020
France
Recruiting Antoine Adenis 33-3-2029-5921
Centre Hospitalier General De Saint-Malo *Recruiting*
Saint-Malo, , 35400
France
Recruiting Philippe Thevenet 33-2-9921-2155
CHR D'Orleans - Hopital de la Source *Recruiting*
Orleans, , 45067
France
Recruiting Remy Leloup 33-2-3851-4515
Additional Information:
Study ID Numbers: CDR0000257600; SFRO-FFCD-9901,FFCD-9901,FRE-GERCOR-FFCD-9901,FRE-FNCLCC-FFCD-9901,EORTC-22001,EU-20215,EORTC-40001
Study Start Date:
Record last reviewed: September 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00047112
Other Stage 2 Esophageal Cancer Studies:
1. Positron Emission Tomography in Determining Stage of Esophageal Cancer
2. Celecoxib, Paclitaxel, and Carboplatin in Treating Patients With Cancer of the Esophagus
3. Surgery With or Without Combination Chemotherapy in Treating Patients With Cancer of the Esophagus
4. Oxaliplatin and Fluorouracil Plus Radiation Therapy in Treating Patients With Primary Esophageal or Stomach Cancer
5. Surgery With or Without Chemotherapy and Radiation Therapy in Treating Patients With Cancer of the Esophagus
Related Studies:
Other stage 2 esophageal cancer Clinical Trials
Other Clinical Trials
Other Nice Clinical Trials
Surgery With or Without Radiation Therapy and Chemotherapy in Treating Patients With Esophageal Cancer
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