Radiation Therapy or No Radiation Therapy Following Chemotherapy in Treating Patients With Stage III or Stage IV Hodgkin's Disease

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2006 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00002462
First received: November 1, 1999
Last updated: November 2, 2010
Last verified: November 2006
  Purpose

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 Intervention Phase
Lymphoma
Biological: bleomycin sulfate
Drug: doxorubicin hydrochloride
Drug: mechlorethamine hydrochloride
Drug: prednisone
Drug: procarbazine hydrochloride
Drug: vinblastine sulfate
Drug: vincristine sulfate
Radiation: low-LET cobalt-60 gamma ray therapy
Radiation: low-LET photon therapy
Radiation: radiation therapy
Phase 3

Study Type: Interventional
Study Design: Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: September 1989
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

Ages Eligible for Study:   15 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

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

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00002462

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

Additional Information:
Publications:
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.

ClinicalTrials.gov Identifier: NCT00002462     History of Changes
Other Study ID Numbers: CDR0000075903, EORTC-20884
Study First Received: November 1, 1999
Last Updated: November 2, 2010
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage III adult Hodgkin lymphoma
stage IV adult Hodgkin lymphoma

Additional relevant MeSH terms:
Lymphoma
Hodgkin Disease
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Doxorubicin
Liposomal doxorubicin
Bleomycin
Vincristine
Vinblastine
Procarbazine
Mechlorethamine
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Alkylating Agents
Antineoplastic Agents, Alkylating

ClinicalTrials.gov processed this record on September 18, 2014