RT or No RT Following Chemotherapy in Treating Patients With Stage III/IV Hodgkin's Disease

Last updated: February 21, 2024
Sponsor: European Organisation for Research and Treatment of Cancer - EORTC
Overall Status: Active - Not Recruiting

Phase

3

Condition

Lymphoma

Treatment

low-LET photon therapy

prednisone

radiation therapy

Clinical Study ID

NCT00002462
EORTC-20884
EORTC-20884
  • Ages 15-70
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

Study Design

Total Participants: 615
Treatment Group(s): 10
Primary Treatment: low-LET photon therapy
Phase: 3
Study Start date:
September 01, 1989
Estimated Completion Date:

Study 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.

Connect with a study center

  • Algemeen Ziekenhuis Middelheim

    Antwerp, 2020
    Belgium

    Site Not Available

  • A.Z. St. Jan

    Brugge, 8000
    Belgium

    Site Not Available

  • Hopital Universitaire Erasme

    Brussels, 1070
    Belgium

    Site Not Available

  • C.H.U. Saint-Pierre

    Brussels (Bruxelles), 1000
    Belgium

    Site Not Available

  • Centre Hospitalier Universitaire Brugmann

    Brussels (Bruxelles), B 1020
    Belgium

    Site Not Available

  • Institut Jules Bordet

    Brussels (Bruxelles), 1000
    Belgium

    Site Not Available

  • Centre Hospitalier Universitaire de Tivoli

    La Louviere, 7100
    Belgium

    Site Not Available

  • U.Z. Gasthuisberg

    Leuven, B-3000
    Belgium

    Site Not Available

  • U.Z. Sint-Rafael

    Leuven, B-3000
    Belgium

    Site Not Available

  • National Cancer Institute of Egypt

    Cairo,
    Egypt

    Site Not Available

  • Institut Bergonie

    Bordeaux, 33076
    France

    Site Not Available

  • Centre Regional Francois Baclesse

    Caen, 14076
    France

    Site Not Available

  • Centre Hospitalier General

    Compiegne, 60321
    France

    Site Not Available

  • Centre Georges-Francois Leclerc

    Dijon, 21034
    France

    Site Not Available

  • Centre Leon Berard

    Lyon, 69373
    France

    Site Not Available

  • Hopital Edouard Herriot

    Lyon, 69437
    France

    Site Not Available

  • Centre Antoine Lacassagne

    Nice, 06189
    France

    Site Not Available

  • Hopital Cochin

    Paris, 75674
    France

    Site Not Available

  • Hopital Necker

    Paris, 75743
    France

    Site Not Available

  • Hopital Saint Antoine

    Paris, 75571
    France

    Site Not Available

  • Hotel Dieu de Paris

    Paris, 75181
    France

    Site Not Available

  • Hopital Jules Courmont - Centre Hospitalier Lyon Sud

    Pierre Benite, 69495
    France

    Site Not Available

  • Hopital Sud

    Rennes, 35056
    France

    Site Not Available

  • Centre Henri Becquerel

    Rouen, 76038
    France

    Site Not Available

  • Centre Medico-Chirurgical Foch

    Suresnes, 92151
    France

    Site Not Available

  • Centre Alexis Vautrin

    Vandoeuvre-les-Nancy, 54511
    France

    Site Not Available

  • Institut Gustave Roussy

    Villejuif, F-94805
    France

    Site Not Available

  • Zentralkrankenhaus

    Bremen, D-28205
    Germany

    Site Not Available

  • Centro di Riferimento Oncologico - Aviano

    Aviano, 33081
    Italy

    Site Not Available

  • Dipartimente di Oncologia di Torino

    Turin (Torino), 10123
    Italy

    Site Not Available

  • Leyenburg Ziekenhuis

    's-Gravenhage (Den Haag, The Hague), 2545 CH
    Netherlands

    Site Not Available

  • Groot Ziekengasthuis 's-Hertogenbosch

    's-Hertogenbosch, 5211 NL
    Netherlands

    Site Not Available

  • Medisch Centrum Alkmaar

    Alkmaar, 1815 JD
    Netherlands

    Site Not Available

  • Antoni van Leeuwenhoekhuis

    Amsterdam, 1066 CX
    Netherlands

    Site Not Available

  • Integraal Kankercentrum Amsterdam

    Amsterdam, 1066 CX
    Netherlands

    Site Not Available

  • Onze Lieve Vrouwe Gasthuis

    Amsterdam, 1091 HA
    Netherlands

    Site Not Available

  • Slotervaart Ziekenhuis

    Amsterdam, 1066 EC
    Netherlands

    Site Not Available

  • Streekziekenhuizen Gooi-Noord

    Blaricum, 1261 AN
    Netherlands

    Site Not Available

  • Catharina Ziekenhuis

    Eindhoven, 5602 ZA
    Netherlands

    Site Not Available

  • Medisch Spectrum Twente

    Enschede, 7500 KA
    Netherlands

    Site Not Available

  • De Wever Ziekenhuis

    Heerlen, 6419 PC
    Netherlands

    Site Not Available

  • Radiotherapeutisch Instituut

    Leeuwarden, 8934 AD
    Netherlands

    Site Not Available

  • Integraal Kankercentrum West

    Leiden, 2316 XB
    Netherlands

    Site Not Available

  • Leiden University Medical Center

    Leiden, 2300 ZA
    Netherlands

    Site Not Available

  • Academisch Ziekenhuis Maastricht

    Maastricht, 6202 AZ
    Netherlands

    Site Not Available

  • St. Radboud University Hospital

    Nijmegen, 6500 HB
    Netherlands

    Site Not Available

  • Rotterdam Cancer Institute

    Rotterdam, 3075 EA
    Netherlands

    Site Not Available

  • University Hospital - Rotterdam Dijkzigt

    Rotterdam, 3000 CA
    Netherlands

    Site Not Available

  • Sophia Ziekehuis

    Zwolle, 8000 GK
    Netherlands

    Site Not Available

  • Maritime Hospital

    Gdynia, PL-81--519
    Poland

    Site Not Available

  • Jagiellonian University

    Krakow (Cracow), 31-826
    Poland

    Site Not Available

  • Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology

    Warsaw, 02-781
    Poland

    Site Not Available

  • Hospitais da Universidade de Coimbra (HUC)

    Coimbra, 3049
    Portugal

    Site Not Available

  • Instituto Portugues de Oncologia de Francisco Gentil

    Lisbon, 1093
    Portugal

    Site Not Available

  • Instituto Portugues de Oncologia do Porto

    Porto, 4200
    Portugal

    Site Not Available

  • Institute of Oncology, Ljubljana

    Ljubljana, Sl-1000
    Slovenia

    Site Not Available

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