Spots Global Cancer Trial Database for RT or No RT Following Chemotherapy in Treating Patients With Stage III/IV Hodgkin's Disease
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Trial Identification
Brief Title: RT or No RT Following Chemotherapy in Treating Patients With Stage III/IV Hodgkin's Disease
Official Title: Phase III Randomized Trial of Adjuvant Involved-Field Radiotherapy vs No Adjuvant Therapy Following Remission Induction With MOPP/ABV Hybrid Chemotherapy in Patients With Stage III/IV Hodgkin's Disease
Study ID: NCT00002462
Conditions
Study Description
Brief Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining radiation therapy with combination chemotherapy may kill more tumor cells. PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy with no radiation therapy following chemotherapy in treating patients with stage III or stage IV Hodgkin's disease.
Detailed Description: OBJECTIVES: I. Compare relapse-free survival and overall survival of patients with Stage III/IV Hodgkin's disease randomly assigned to adjuvant involved-field radiotherapy vs. no adjuvant therapy following remission induction with MOPP/ABV (nitrogen mustard/vincristine/procarbazine/prednisone/doxorubicin/bleomycin/vinblastine). II. Evaluate the therapeutic efficacy of MOPP/ABV hybrid chemotherapy in advanced Hodgkin's disease. III. Evaluate the prognostic significance of an early response to MOPP/ABV in patients with advanced Hodgkin's disease. OUTLINE: Study randomized for adjuvant radiotherapy. All patients receive Induction chemotherapy on Regimen A, following which those in CR are randomized on Arms I and II. Regimen A: 7-Drug Combination Chemotherapy. MOPP/ABV Hybrid. Mechlorethamine, NM, NSC-762; Vincristine, VCR, NSC-67574; Procarbazine, PCB, NSC-77213; Prednisone, PRED, NSC-10023; Doxorubicin, DOX, NSC-123127; Bleomycin, BLEO, NSC-125066; Vinblastine, VBL, NSC-49842. Arm I: Radiotherapy. Involved-field irradiation using megavoltage equipment. Arm II: No further therapy. PROJECTED ACCRUAL: 321 evaluable patients will be required; an annual accrual rate of 80 patients is anticipated.
Eligibility
Minimum Age: 15 Years
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Algemeen Ziekenhuis Middelheim, Antwerp, , Belgium
A.Z. St. Jan, Brugge, , Belgium
C.H.U. Saint-Pierre, Brussels (Bruxelles), , Belgium
Institut Jules Bordet, Brussels (Bruxelles), , Belgium
Centre Hospitalier Universitaire Brugmann, Brussels (Bruxelles), , Belgium
Hopital Universitaire Erasme, Brussels, , Belgium
Centre Hospitalier Universitaire de Tivoli, La Louviere, , Belgium
U.Z. Gasthuisberg, Leuven, , Belgium
U.Z. Sint-Rafael, Leuven, , Belgium
National Cancer Institute of Egypt, Cairo, , Egypt
Institut Bergonie, Bordeaux, , France
Centre Regional Francois Baclesse, Caen, , France
Centre Hospitalier General, Compiegne, , France
Centre Georges-Francois Leclerc, Dijon, , France
Centre Leon Berard, Lyon, , France
Hopital Edouard Herriot, Lyon, , France
Centre Antoine Lacassagne, Nice, , France
Hotel Dieu de Paris, Paris, , France
Hopital Saint Antoine, Paris, , France
Hopital Cochin, Paris, , France
Hopital Necker, Paris, , France
Hopital Jules Courmont - Centre Hospitalier Lyon Sud, Pierre Benite, , France
Hopital Sud, Rennes, , France
Centre Henri Becquerel, Rouen, , France
Centre Medico-Chirurgical Foch, Suresnes, , France
Centre Alexis Vautrin, Vandoeuvre-les-Nancy, , France
Institut Gustave Roussy, Villejuif, , France
Zentralkrankenhaus, Bremen, , Germany
Centro di Riferimento Oncologico - Aviano, Aviano, , Italy
Dipartimente di Oncologia di Torino, Turin (Torino), , Italy
Leyenburg Ziekenhuis, 's-Gravenhage (Den Haag, The Hague), , Netherlands
Groot Ziekengasthuis 's-Hertogenbosch, 's-Hertogenbosch, , Netherlands
Medisch Centrum Alkmaar, Alkmaar, , Netherlands
Antoni van Leeuwenhoekhuis, Amsterdam, , Netherlands
Integraal Kankercentrum Amsterdam, Amsterdam, , Netherlands
Slotervaart Ziekenhuis, Amsterdam, , Netherlands
Onze Lieve Vrouwe Gasthuis, Amsterdam, , Netherlands
Streekziekenhuizen Gooi-Noord, Blaricum, , Netherlands
Catharina Ziekenhuis, Eindhoven, , Netherlands
Medisch Spectrum Twente, Enschede, , Netherlands
De Wever Ziekenhuis, Heerlen, , Netherlands
Radiotherapeutisch Instituut, Leeuwarden, , Netherlands
Leiden University Medical Center, Leiden, , Netherlands
Integraal Kankercentrum West, Leiden, , Netherlands
Academisch Ziekenhuis Maastricht, Maastricht, , Netherlands
St. Radboud University Hospital, Nijmegen, , Netherlands
University Hospital - Rotterdam Dijkzigt, Rotterdam, , Netherlands
Rotterdam Cancer Institute, Rotterdam, , Netherlands
Sophia Ziekehuis, Zwolle, , Netherlands
Maritime Hospital, Gdynia, , Poland
Jagiellonian University, Krakow (Cracow), , Poland
Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Warsaw, , Poland
Hospitais da Universidade de Coimbra (HUC), Coimbra, , Portugal
Instituto Portugues de Oncologia de Francisco Gentil, Lisbon, , Portugal
Instituto Portugues de Oncologia do Porto, Porto, , Portugal
Institute of Oncology, Ljubljana, Ljubljana, , Slovenia
Contact Details
Name: John Raemaekers, MD, PhD
Affiliation: Universitair Medisch Centrum St. Radboud - Nijmegen
Role: STUDY_CHAIR
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