RT or No RT Following Chemotherapy in Treating Patients With Stage III/IV Hodgkin's Disease
NCT ID: NCT00002462
Last Updated: 2025-08-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
615 participants
INTERVENTIONAL
1989-09-30
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
TREATMENT
Interventions
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bleomycin sulfate
doxorubicin hydrochloride
mechlorethamine hydrochloride
prednisone
procarbazine hydrochloride
vinblastine sulfate
vincristine sulfate
low-LET cobalt-60 gamma ray therapy
low-LET photon therapy
radiation therapy
Eligibility Criteria
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Exclusion Criteria
PRIOR CONCURRENT THERAPY: No prior therapy
15 Years
70 Years
ALL
No
Sponsors
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European Organisation for Research and Treatment of Cancer - EORTC
NETWORK
Responsible Party
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Principal Investigators
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John Raemaekers, MD, PhD
Role: STUDY_CHAIR
Universitair Medisch Centrum St. Radboud - Nijmegen
Locations
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Algemeen Ziekenhuis Middelheim
Antwerp, , Belgium
A.Z. St. Jan
Bruges, , Belgium
Hopital Universitaire Erasme
Brussels, , Belgium
C.H.U. Saint-Pierre
Brussels (Bruxelles), , Belgium
Institut Jules Bordet
Brussels (Bruxelles), , Belgium
Centre Hospitalier Universitaire Brugmann
Brussels (Bruxelles), , Belgium
Centre Hospitalier Universitaire de Tivoli
La Louvière, , 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
Compiègne, , 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-Bénite, , France
Hopital Sud
Rennes, , France
Centre Henri Becquerel
Rouen, , France
Centre Medico-Chirurgical Foch
Suresnes, , France
Centre Alexis Vautrin
Vandœuvre-lès-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
Countries
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References
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Aleman BM, Raemaekers JM, Tomisic R, Baaijens MH, Bortolus R, Lybeert ML, van der Maazen RW, Girinsky T, Demeestere G, Lugtenburg P, Lievens Y, de Jong D, Pinna A, Henry-Amar M; European Organization for Research and Treatment of Cancer (EORTC) Lymphoma Group. Involved-field radiotherapy for patients in partial remission after chemotherapy for advanced Hodgkin's lymphoma. Int J Radiat Oncol Biol Phys. 2007 Jan 1;67(1):19-30. doi: 10.1016/j.ijrobp.2006.08.041. Epub 2006 Nov 9.
Aleman BM, Girinsky T, van der Maazen RW, Strijk S, Meijnders P, Bortolus R, Olofsen-van Acht MJ, Lybeert ML, Lievens Y, Eghbali H, Noordijk EM, Tomsic R, Meerwaldt JH, Poortmans PM, Smit WG, Pinna A, Henry-Amar M, Raemaekers JM; European Organization for Research; Treatment of Cancer (EORTC) Lymphoma Group. Quality control of involved-field radiotherapy in patients with advanced Hodgkin's lymphoma (EORTC 20884). Int J Radiat Oncol Biol Phys. 2005 Nov 15;63(4):1184-90. doi: 10.1016/j.ijrobp.2005.03.044. Epub 2005 Jun 2.
Aleman BMP, Girinsky T, Strijk S, et al.: Quality control of involved-field radiotherapy in patients with advanced stage Hodgkin's lymphoma (HL) enrolled on the EORTC trial 20884. [Abstract] Eur J Haematol 73 (Suppl 65): A-A02, 42, 2004.
Aleman BMP, Raemaekers JMM, Tomsic R, et al.: Radiotherapy in advanced Hodgkin lymphoma (HL) patients in partial remission (PR) after chemotherapy: detailed results from the EORTC lymphoma group trial no.20884. [Abstract] Eur J Haematol 73 (Suppl 65): A-A01, 42, 2004.
Aleman BM, Raemaekers JM, Henry-Amar M, et al.: Involved-field radiotherapy in patients with stage III/IV Hodgkin's lymphoma: first results of the randomised EORTC trial # 20884. [Abstract] Int J Radiat Oncol Biol Phys 51(3 suppl 1): A-3, 2, 2001.
Raemaekers J, Burgers M, Henry-Amar M, Pinna A, Mandard A, Monfardini S, Hagenbeek A, Breed W, Carde P, Vovk M, van Hoof A, Thomas J, Noordijk E. Patients with stage III/IV Hodgkin's disease in partial remission after MOPP/ABV chemotherapy have excellent prognosis after additional involved-field radiotherapy: interim results from the ongoing EORTC-LCG and GPMC phase III trial. The EORTC Lymphoma Cooperative Group and Groupe Pierre-et-Marie-Curie. Ann Oncol. 1997;8 Suppl 1:111-4.
Other Identifiers
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EORTC-20884
Identifier Type: OTHER
Identifier Source: secondary_id
EORTC-20884
Identifier Type: -
Identifier Source: org_study_id
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