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Spots Global Cancer Trial Database for Combination Chemotherapy With or Without Radiation Therapy in Treating Patients With Hodgkin's Lymphoma

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Trial Identification

Brief Title: Combination Chemotherapy With or Without Radiation Therapy in Treating Patients With Hodgkin's Lymphoma

Official Title: Prospective Controlled Trial in Clinical Stages I-II Supradiaphragmatic Hodgkin's Disease: Evaluation of Treatment Efficacy, (Long Term) Toxicity and Quality of Life in Two Different Prognostic Subgroups

Study ID: NCT00005584

Conditions

Lymphoma

Study Description

Brief Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage cancer cells. Combining chemotherapy with radiation therapy may kill more cancer cells. It is not yet known which combination chemotherapy regimen is most effective in treating Hodgkin's lymphoma. PURPOSE: Randomized phase III trial to compare the effectiveness of different regimens of combination chemotherapy with or without radiation therapy in treating patients who have Hodgkin's lymphoma.

Detailed Description: OBJECTIVES: * Compare the late toxicity of 6 courses of epirubicin, bleomycin, vinblastine, and prednisone (EBVP) followed by involved-field radiotherapy (IF-RT) (36 Gy) vs IF-RT (20 Gy), vs no IF-RT (closed to accrual as of 6/2002) in patients with supradiaphragmatic Hodgkin's lymphoma, favorable prognosis, and complete remission (CR) or CR unconfirmed after completion of chemotherapy. (Favorable prognosis group \[group 1\] closed to accrual as of 4/28/04.) * Compare 6 courses of doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD) vs 4 courses of ABVD vs 4 courses of cyclophosphamide, doxorubicin, vincristine, bleomycin, etoposide, procarbazine, and prednisone (BEACOPP) followed by IF-RT, with respect to overall survival and late treatment-related toxicity, in patients with supradiaphragmatic Hodgkin's lymphoma and unfavorable prognosis. (Unfavorable prognosis group \[group 2\] closed to accrual as of 9/2002.) (Favorable prognosis group \[group 1\] closed to accrual as of 4/28/04.) * Maintain the failure-free survival and relapse-free survival rates that were reached in the previous EORTC studies (H5 to H8), with a reduction in acute and delayed side effects of the treatment, in particular that of severe late radiotherapy and chemotherapy-related toxicity. * Compare the quality of life, overall survival, treatment quality control, and duration of treatment in patients with favorable (closed to accrual as of 4/28/04) or unfavorable (closed to accrual as of 9/2002) prognoses treated with these regimens. * Determine the efficacy of conservative therapy comprised of observation until disease progression (DP) and administration of IF-RT at the time of DP in patients with lymphocyte-predominant Hodgkin's lymphoma, nodular subtype (nodular paragranuloma). OUTLINE: This is a randomized, multicenter study. Patients with classical Hodgkin's lymphoma are assigned to 1 of 2 randomized groups. (Group 2 \[unfavorable prognosis\] closed to accrual as of 9/2002.) (Group 1 \[favorable prognosis\] closed to accrual as of 4/28/04.) Patients with lymphocyte-predominant Hodgkin's lymphoma are assigned to the nonrandomized group. Randomized groups * Patients are stratified by prognosis (favorable vs unfavorable). Patients are assigned to 1 of 2 treatment groups based on prognosis. (Group 2 \[unfavorable prognosis\] closed to accrual as of 9/2002.) (Group 1 \[favorable prognosis\] closed to accrual as of 4/28/04.) * Group 1 (favorable prognosis) (closed to accrual as of 4/28/04): Patients receive epirubicin IV over 5 minutes, bleomycin intramuscularly (IM) (or IV if necessary), and vinblastine IV on day 1 and oral prednisone on days 1-5. Treatment repeats every 3 weeks for 6 courses. Patients are then assigned to 1 of 3 involved-field radiotherapy (IF-RT) groups based on response to chemotherapy: * Group A (complete remission (CR) or CR unconfirmed \[CRu\]) Patients are randomized to 1 of 3 radiotherapy arms. (Arm III closed to accrual as of 6/2002.) * Arm I (36 Gy): Patients undergo IF-RT 5 days a week for 3.5 weeks. * Arm II (20 Gy): Patients undergo IF-RT 5 days a week for 2 weeks. * Arm III (closed to accrual as of 6/2002): Patients undergo no IF-RT. * Group B (partial remission \[PR\]): Patients undergo IF-RT 5 days a week for 3.5 weeks and boost radiotherapy. * Group C (stable disease or disease progression \[DP\]): Patients receive no IF-RT and are taken off study. * Group 2 (unfavorable prognosis) (closed to accrual as of 9/2002): Patients are randomized to 1 of 3 treatment arms. * Arm I: Patients receive doxorubicin IV over 5 minutes, bleomycin IM (or IV if necessary), vinblastine IV, and dacarbazine IV over 5-10 minutes on days 1 and 15. Treatment repeats every 4 weeks for 6 courses. * Arm II: Patients receive chemotherapy as in arm I. Treatment repeats every 4 weeks for 4 courses. * Arm III: Patients receive cyclophosphamide IV and doxorubicin IV over 5 minutes on day 1, vincristine IV and bleomycin IM (or IV if necessary) on day 8, etoposide IV over a minimum of 30 minutes on days 1-3, oral procarbazine on days 1-7, and oral prednisone on days 1-14. Treatment repeats every 3 weeks for 4 courses. Patients on all arms who achieve CR or CRu undergo IF-RT 5 days a week for 3 weeks. Patients who achieve PR undergo IF-RT 5 days a week for 3.5 weeks and boost radiotherapy. * Groups 1 and 2 (group 2 closed to accrual as of 9/2002) (group 1 closed to accrual as of 4/28/04): IF-RT begins within 3-4 weeks after completion of the last course of chemotherapy. Nonrandomized group * Patients with completely resected stage I disease undergo observation until DP and undergo IF-RT after documentation of DP. Patients with stage II or incompletely resected stage I disease undergo IF-RT immediately. Quality of life is assessed before starting study therapy, immediately after completion of study, and then annually for 10 years. Patients are followed at 2, 4, 6, 9, and 12 months; every 4 months for 1 year; every 6 months for 3 years; and then annually thereafter. PROJECTED ACCRUAL: A total of 903 patients (group 1) will be accrued for this study within 7.7 years. A total of 723 patients (group 2) will be accrued for this study within 3.8 years. (Group 2 \[unfavorable prognosis\] closed to accrual as of 9/2002.) (Group 1 \[favorable prognosis\] closed to accrual as of 4/28/04.)

Eligibility

Minimum Age: 15 Years

Eligible Ages: CHILD, ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Sint Augustinus Ziekenhuis, Antwerpen, , Belgium

A.Z. St. Jan, Brugge, , Belgium

C.H.U. Saint-Pierre, Brussels, , Belgium

Institut Jules Bordet, Brussels, , Belgium

Cliniques Universitaires Saint-Luc, Brussels, , Belgium

Centre Hospitalier Universitaire Brugmann, Brussels, , Belgium

Universitair Ziekenhuis Antwerpen, Edegem, , Belgium

U.Z. Gasthuisberg, Leuven, , Belgium

Clinique Universitaire De Mont-Godinne, Mont-Godinne Yvoir, , Belgium

Clinique Saint-Pierre, Ottignies, , Belgium

Centre Hospitalier Annemasse Bonneville, Ambilly, , France

Centre Hospitalier d'Annecy, Annecy, , France

Centre Hospital General Robert Ballanger, Aulnay Sous Bois, , France

Hopital Duffaut, Avignon, , France

Centre Hospitalier de la Cote Basque, Bayonne, , France

CHR de Besancon - Hopital Jean Minjoz, Besancon, , France

Hopital de Beziers, Beziers, , France

Hopital Saint Andre, Bordeaux, , France

Institut Bergonie, Bordeaux, , France

C.H. Bourg En Bresse, Bourg En Bresse, , France

CMC Bligny, Briis Sous Forges, , France

CHU de Caen, Caen, , France

Centre Regional Francois Baclesse, Caen, , France

Centre Hospitalier Regional de Chambery, Chambery, , France

Hopital Fontenoy, Chartres, , France

Centre d'Oncologie et de Radiotherapie de Chaumont le Bois, Chaumont, , France

Hopital d'Instruction des Armees Percy, Clamart, , France

Hopital Antoine Beclere, Clamart, , France

Hopital Beaujon, Clichy, , France

Hopital Louis Pasteur, Colmar, , France

Centre Hospitalier Compiegne, Compiegne, , France

Centre Hospitalier Sud Francilien - Site Corbeil, Corbeil, , France

Centre Hospitalier Universitaire Henri Mondor, Creteil, , France

Hopital Du Bocage, Dijon, , France

Centre de Lutte Contre le Cancer, Georges-Francois Leclerc, Dijon, , France

Institut Prive de Cancerologie, Grenoble, , France

Centre Hospitalier, Juvisy sur Orge, , France

Hopital Andre Mignot, Le Chesnay, , France

C.H.G. Du Havre - Hopital J. Monod, Le Havre, , France

Centre Hospitalier Universitaire de Bicetre, Le Kremlin Bicetre, , France

Clinique Victor Hugo, Le Mans, , France

Centre Hospitalier Lens, Lens, , France

Centre Hospital Universitaire Hop Huriez, Lille, , France

Centre Hospitalier Regional et Universitaire de Lille, Lille, , France

Centre Hospital Regional Universitaire de Limoges, Limoges, , France

Centre Hospitalier General, Lons le Saunier, , France

Clinique Saint Jean, Lyon, , France

Centre Leon Berard, Lyon, , France

Hopital Edouard Herriot, Lyon, , France

Institut J. Paoli and I. Calmettes, Marseille, , France

Centre Hospitalier de Meaux, Meaux, , France

Hopital Notre-Dame de Bon Secours, Metz, , France

Intercommunal Hospital, Montfermeil, , France

Clinique Gui de Chauliac, Montpellier, , France

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

Centre Hospitalier de Mulhouse, Mulhouse, , France

Hopital Pasteur, Nice, , France

Centre Antoine Lacassagne, Nice, , France

C.H.U. de Nimes - Groupe Hospitals-Universitaire Caremeau, Nimes, , France

Hopital Saint Antoine, Paris, , France

Hopital de la Croix Rouge Francaise des Peupliers, Paris, , France

Hotel Dieu de Paris, Paris, , France

Institut Curie - Section Medicale, Paris, , France

Hopital Lariboisiere, Paris, , France

Hopital Saint-Louis, Paris, , France

CHU Pitie-Salpetriere, Paris, , France

Hopital Cochin, Paris, , France

Hopital Necker, Paris, , France

C.H.G. De Pau, Pau, , France

Hopital Haut Leveque, Pessac, , France

Centre Hospitalier Lyon Sud, Pierre Benite, , France

Centre Hospitalier Intercommunal de Poissy, Poissy, , France

Hopital Rene Dubos, Pontoise, , France

Polyclinique De Courlancy, Reims, , France

CHG Roanne, Roanne, , France

Centre Henri Becquerel, Rouen, , France

Centre Rene Huguenin, Saint Cloud, , France

C.H.U. Saint Etienne Hospital Nord, Saint Etienne, , France

Hopital de Saint Germain-en-Laye, Saint Germain-en-Laye, , France

Centre Medico-Chirurgical Foch, Suresnes, , France

Centre Hospitalier Regional de Purpan, Toulouse, , France

Centre Hospitalier Valence, Valence, , France

Centre Hospitalier de Valenciennes, Valenciennes, , France

Centre Alexis Vautrin, Vandoeuvre-les-Nancy, , France

CHU de Nancy - Hopitaux de Brabois, Vandoeuvre-Les-Nancy, , France

Hopital Paul Brousse, Villejuif, , France

Institut Gustave Roussy, Villejuif, , France

Centro di Riferimento Oncologico - Aviano, Aviano, , Italy

Ospedale Sta. Maria Delle Croci, Ravenna, , Italy

Ospedale S. Giovanni A.S. Dipartimente di Oncologia di Turin, Turin, , Italy

Leyenburg Ziekenhuis, 's-Gravenhage, , Netherlands

Groot Ziekengasthuis 's-Hertogenbosch, 's-Hertogenbosch, , Netherlands

Medisch Centrum Alkmaar, Alkmaar, , Netherlands

Meander Medisch Centrum, Amersfoort, , Netherlands

Comprehensive Cancer Center Amsterdam, Amsterdam, , Netherlands

Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital, Amsterdam, , Netherlands

Onze Lieve Vrouwe Gasthuis, Amsterdam, , Netherlands

Academisch Medisch Centrum, Amsterdam, , Netherlands

Streekziekenhuizen Gooi-Noord, Blaricum, , Netherlands

Amphia Ziekenhuis - locatie Molengracht, Breda, , Netherlands

Atrium Medisch Centrum - Brunssum, Brunssum, , Netherlands

Reinier de Graaf Group, Delft, , Netherlands

Catharina Ziekenhuis, Eindhoven, , Netherlands

Medisch Spectrum Twente, Enschede, , Netherlands

Academisch Ziekenhuis Groningen, Groningen, , Netherlands

Atrium Medical Centre, Heerlen, , Netherlands

Radiotherapeutisch Instituut, Leeuwarden, , Netherlands

Diaconessenhuis Leiden, Leiden, , Netherlands

Academisch Ziekenhuis Maastricht, Maastricht, , Netherlands

Sint Antonius Ziekenhuis, Nieuwegein, , Netherlands

University Medical Center Nijmegen, Nijmegen, , Netherlands

Daniel Den Hoed Cancer Center at Erasmus Medical Center, Rotterdam, , Netherlands

Maasland Hospital, Sittard, , Netherlands

Academisch Ziekenhuis Utrecht, Utrecht, , Netherlands

Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Warsaw, , Poland

Instituto Portugues de Oncologia Centro do Porto, SA, Porto, , Portugal

National Cancer Institute - Bratislava, Bratislava, , Slovakia

Institute of Oncology, Ljubljana, Ljubljana, , Slovenia

Hospital Universitario 12 de Octubre, Madrid, , Spain

Hopital Cantonal Universitaire de Geneve, Geneva, , Switzerland

Centre Hospitalier Universitaire Vaudois, Lausanne, , Switzerland

Contact Details

Name: Jose Thomas, MD

Affiliation: University Hospital, Gasthuisberg

Role: STUDY_CHAIR

Name: H. Eghbali, MD

Affiliation: Institut Bergonié

Role: STUDY_CHAIR

Name: E.M. Noordijk, MD

Affiliation: Leiden University Medical Center

Role: STUDY_CHAIR

Name: Christophe Ferme

Affiliation: Centre Medical de Bligny

Role: STUDY_CHAIR

Name: Christian Gisselbrecht, MD

Affiliation: Hopital Saint-Louis

Role: STUDY_CHAIR

Name: Thierry O. Philip, MD

Affiliation: Centre Leon Berard

Role: STUDY_CHAIR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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