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.

Condition	Treatment or Intervention	Phase
stage III adult Hodgkin's disease stage IV adult Hodgkin's disease	Drug: bleomycin  Drug: doxorubicin  Drug: mechlorethamine  Drug: prednisone  Drug: procarbazine  Drug: vinblastine  Drug: vincristine	Phase III

Further Study Details: 

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.

PROTOCOL 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.

Ages Eligible for Study:  15 Years   -   70 Years

Criteria

PROTOCOL ENTRY CRITERIA:

--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

--Prior/Concurrent Therapy--

• No prior therapy

--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

Belgium
      A.Z. St. Jan, Brugge,  8000,  Belgium
      Algemeen Ziekenhuis Middelheim, Antwerp,  2020,  Belgium
      C.H.U. Saint-Pierre, Brussels (Bruxelles),  1000,  Belgium
      Centre Hospitalier Universitaire Brugmann, Brussels (Bruxelles),  B 1020,  Belgium
      Centre Hospitalier Universitaire de Tivoli, La Louviere,  7100,  Belgium
      Hopital Universitaire Erasme, Brussels,  1070,  Belgium
      Institut Jules Bordet, Brussels (Bruxelles),  1000,  Belgium
      U.Z. Gasthuisberg, Leuven,  B-3000,  Belgium
      U.Z. Sint-Rafael, Leuven,  B-3000,  Belgium
Egypt
      National Cancer Institute of Egypt, Cairo,  Egypt
France
      Centre Alexis Vautrin, Vandoeuvre-les-Nancy,  54511,  France
      Centre Antoine Lacassagne, Nice,  06189,  France
      Centre Georges-Francois Leclerc, Dijon,  21034,  France
      Centre Henri Becquerel, Rouen,  76038,  France
      Centre Hospitalier General, Compiegne,  60321,  France
      Centre Leon Berard, Lyon,  69373,  France
      Centre Medico-Chirurgical Foch, Suresnes,  92151,  France
      Centre Regional Francois Baclesse, Caen,  14076,  France
      Hopital Cochin, Paris,  75674,  France
      Hopital Edouard Herriot, Lyon,  69437,  France
      Hopital Jules Courmont - Centre Hospitalier Lyon Sud, Pierre-Benite,  69495,  France
      Hopital Necker, Paris,  75743,  France
      Hopital Saint Antoine, Paris,  75571,  France
      Hopital Sud, Rennes,  35056,  France
      Hotel Dieu de Paris, Paris,  75181,  France
      Institut Bergonie, Bordeaux,  33076,  France
      Institut Gustave Roussy, Villejuif,  F-94805,  France
Germany
      Zentralkrankenhaus, Bremen,  D-28205,  Germany
Italy
      Centro di Riferimento Oncologico - Aviano, Aviano,  33081,  Italy
      Dipartimente di Oncologia di Torino, Turin (Torino),  10123,  Italy
Netherlands
      Academisch Ziekenhuis Maastricht, Maastricht,  6202 AZ,  Netherlands
      Antoni van Leeuwenhoekhuis, Amsterdam,  1066 CX,  Netherlands
      Catharina Ziekenhuis, Eindhoven,  5602 ZA,  Netherlands
      De Wever Ziekenhuis, HEERLEN,  6419 PC,  Netherlands
      Groot Ziekengasthuis 's-Hertogenbosch, 's-Hertogenbosch,  5211 NL,  Netherlands
      Integraal Kankercentrum Amsterdam, Amsterdam,  1066 CX,  Netherlands
      Integraal Kankercentrum West, Leiden,  2316 XB,  Netherlands
      Leiden University Medical Center, Leiden,  2300 ZA,  Netherlands
      Leyenburg Ziekenhuis, 's-Gravenhage (Den Haag, The Hague),  2545 CH,  Netherlands
      Medisch Centrum Alkmaar, Alkmaar,  1815 JD,  Netherlands
      Medisch Spectrum Twente, ENSCHEDE,  7500 KA,  Netherlands
      Onze Lieve Vrouwe Gasthuis, Amsterdam,  1091 HA,  Netherlands
      Radiotherapeutisch Instituut, Leeuwarden,  8934 AD,  Netherlands
      Rotterdam Cancer Institute, Rotterdam,  3075 EA,  Netherlands
      Slotervaart Ziekenhuis, Amsterdam,  1066 EC,  Netherlands
      Sophia Ziekehuis, Zwolle,  8000 GK,  Netherlands
      St. Radboud University Hospital, Nijmegen,  6500 HB,  Netherlands
      Streekziekenhuizen Gooi-Noord, Blaricum,  1261 AN,  Netherlands
      University Hospital - Rotterdam Dijkzigt, Rotterdam,  3000 CA,  Netherlands
Poland
      Jagiellonian University, Krakow (Cracow),  31-826,  Poland
      Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Warsaw,  02-781,  Poland
      Maritime Hospital, Gdynia,  PL-81--519,  Poland
Portugal
      Hospitais da Universidade de Coimbra (HUC), Coimbra,  3049,  Portugal
      Instituto Portugues de Oncologia de Francisco Gentil, Lisbon,  1093,  Portugal
      Instituto Portugues de Oncologia do Porto, Porto,  4200,  Portugal
Slovenia
      Institute of Oncology, Ljubljana, LJUBLJANA,  Sl-1000,  Slovenia

Study chairs or principal investigators

John Raemaekers,  Study Chair,  EORTC Lymphoma Cooperative Group   

Study ID Numbers:  CDR0000075903; EORTC-20884
Record last reviewed:  July 2004
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00002462
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08