ClinicalTrials.gov processed this data on March 28, 2024Link to the current ClinicalTrials.gov record.https://clinicaltrials.gov/ct2/show/NCT00002462EORTC-20884EORTC-20884NCT00002462RT or No RT Following Chemotherapy in Treating Patients With Stage III/IV Hodgkin's DiseasePhase 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 DiseaseEuropean Organisation for Research and Treatment of Cancer - EORTCOther
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.
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.
Active, not recruitingSeptember 1989May 2000Phase 3InterventionalNoRandomizedTreatmentBenefit of adjuvant involved field RT after entering complete remission with MOPP/ABV hybrid CTEfficacy of MOPP/ABV hybrid CTRelapse free survivalOverall survival615LymphomaBiologicalbleomycin sulfateDrugdoxorubicin hydrochlorideDrugmechlorethamine hydrochlorideDrugprednisoneDrugprocarbazine hydrochlorideDrugvinblastine sulfateDrugvincristine sulfateRadiationlow-LET cobalt-60 gamma ray therapyRadiationlow-LET photon therapyRadiationradiation therapy
DISEASE CHARACTERISTICS: Histologically proven clinical or pathological Stage III/IV
Hodgkin's disease Pathological Stage IIIAS disease with the spleen as the only site of
subdiaphragmatic involvement excluded
PATIENT CHARACTERISTICS: Age: 15 to 70 Performance status: Not specified Life expectancy:
No severe limits on life expectancy due to nonmalignant disease Hematopoietic: Not
specified Hepatic: Not specified Renal: Not specified Cardiovascular: No severe cardiac
disease that would preclude protocol therapy Pulmonary: No severe pulmonary disease that
would preclude protocol therapy Other: No severe metabolic or neurologic disease that would
preclude protocol therapy No concomitant or previous second malignancy except:
Nonmelanomatous skin cancer In situ carcinoma of the cervix
PRIOR CONCURRENT THERAPY: No prior therapy
All15 Years70 YearsNoJohn Raemaekers, MD, PhDStudy ChairUniversitair Medisch Centrum St. Radboud - NijmegenAlgemeen Ziekenhuis MiddelheimAntwerp2020BelgiumA.Z. St. JanBrugge8000BelgiumC.H.U. Saint-PierreBrussels (Bruxelles)1000BelgiumInstitut Jules BordetBrussels (Bruxelles)1000BelgiumCentre Hospitalier Universitaire BrugmannBrussels (Bruxelles)B 1020BelgiumHopital Universitaire ErasmeBrussels1070BelgiumCentre Hospitalier Universitaire de TivoliLa Louviere7100BelgiumU.Z. GasthuisbergLeuvenB-3000BelgiumU.Z. Sint-RafaelLeuvenB-3000BelgiumNational Cancer Institute of EgyptCairoEgyptInstitut BergonieBordeaux33076FranceCentre Regional Francois BaclesseCaen14076FranceCentre Hospitalier GeneralCompiegne60321FranceCentre Georges-Francois LeclercDijon21034FranceCentre Leon BerardLyon69373FranceHopital Edouard HerriotLyon69437FranceCentre Antoine LacassagneNice06189FranceHotel Dieu de ParisParis75181FranceHopital Saint AntoineParis75571FranceHopital CochinParis75674FranceHopital NeckerParis75743FranceHopital Jules Courmont - Centre Hospitalier Lyon SudPierre Benite69495FranceHopital SudRennes35056FranceCentre Henri BecquerelRouen76038FranceCentre Medico-Chirurgical FochSuresnes92151FranceCentre Alexis VautrinVandoeuvre-les-Nancy54511FranceInstitut Gustave RoussyVillejuifF-94805FranceZentralkrankenhausBremenD-28205GermanyCentro di Riferimento Oncologico - AvianoAviano33081ItalyDipartimente di Oncologia di TorinoTurin (Torino)10123ItalyLeyenburg Ziekenhuis's-Gravenhage (Den Haag, The Hague)2545 CHNetherlandsGroot Ziekengasthuis 's-Hertogenbosch's-Hertogenbosch5211 NLNetherlandsMedisch Centrum AlkmaarAlkmaar1815 JDNetherlandsAntoni van LeeuwenhoekhuisAmsterdam1066 CXNetherlandsIntegraal Kankercentrum AmsterdamAmsterdam1066 CXNetherlandsSlotervaart ZiekenhuisAmsterdam1066 ECNetherlandsOnze Lieve Vrouwe GasthuisAmsterdam1091 HANetherlandsStreekziekenhuizen Gooi-NoordBlaricum1261 ANNetherlandsCatharina ZiekenhuisEindhoven5602 ZANetherlandsMedisch Spectrum TwenteEnschede7500 KANetherlandsDe Wever ZiekenhuisHeerlen6419 PCNetherlandsRadiotherapeutisch InstituutLeeuwarden8934 ADNetherlandsLeiden University Medical CenterLeiden2300 ZANetherlandsIntegraal Kankercentrum WestLeiden2316 XBNetherlandsAcademisch Ziekenhuis MaastrichtMaastricht6202 AZNetherlandsSt. Radboud University HospitalNijmegen6500 HBNetherlandsUniversity Hospital - Rotterdam DijkzigtRotterdam3000 CANetherlandsRotterdam Cancer InstituteRotterdam3075 EANetherlandsSophia ZiekehuisZwolle8000 GKNetherlandsMaritime HospitalGdyniaPL-81--519PolandJagiellonian UniversityKrakow (Cracow)31-826PolandMaria Sklodowska-Curie Memorial Cancer Center and Institute of OncologyWarsaw02-781PolandHospitais da Universidade de Coimbra (HUC)Coimbra3049PortugalInstituto Portugues de Oncologia de Francisco GentilLisbon1093PortugalInstituto Portugues de Oncologia do PortoPorto4200PortugalInstitute of Oncology, LjubljanaLjubljanaSl-1000SloveniaBelgiumEgyptFranceGermanyItalyNetherlandsPolandPortugalSloveniaAleman 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 9.17097834Aleman 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 2.15936157Aleman 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 1:111-4.9187443February 2024November 1, 1999July 23, 2004July 26, 2004February 21, 2024February 21, 2024February 22, 2024Sponsorstage III adult Hodgkin lymphomastage IV adult Hodgkin lymphomaLymphomaHodgkin DiseaseCobaltPrednisoneDoxorubicinLiposomal doxorubicinBleomycinVincristineVinblastineProcarbazineMechlorethamine