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

Results pending

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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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

615 participants

Study Classification

INTERVENTIONAL

Study Start Date

1989-09-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Lymphoma

Study Design

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Allocation Method

RANDOMIZED

Primary Study Purpose

TREATMENT

Interventions

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bleomycin sulfate

Intervention Type BIOLOGICAL

doxorubicin hydrochloride

Intervention Type DRUG

mechlorethamine hydrochloride

Intervention Type DRUG

prednisone

Intervention Type DRUG

procarbazine hydrochloride

Intervention Type DRUG

vinblastine sulfate

Intervention Type DRUG

vincristine sulfate

Intervention Type DRUG

low-LET cobalt-60 gamma ray therapy

Intervention Type RADIATION

low-LET photon therapy

Intervention Type RADIATION

radiation therapy

Intervention Type RADIATION

Eligibility Criteria

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Exclusion Criteria

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
Minimum Eligible Age

15 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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European Organisation for Research and Treatment of Cancer - EORTC

NETWORK

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

A.Z. St. Jan

Bruges, , Belgium

Site Status

Hopital Universitaire Erasme

Brussels, , Belgium

Site Status

C.H.U. Saint-Pierre

Brussels (Bruxelles), , Belgium

Site Status

Institut Jules Bordet

Brussels (Bruxelles), , Belgium

Site Status

Centre Hospitalier Universitaire Brugmann

Brussels (Bruxelles), , Belgium

Site Status

Centre Hospitalier Universitaire de Tivoli

La Louvière, , Belgium

Site Status

U.Z. Gasthuisberg

Leuven, , Belgium

Site Status

U.Z. Sint-Rafael

Leuven, , Belgium

Site Status

National Cancer Institute of Egypt

Cairo, , Egypt

Site Status

Institut Bergonie

Bordeaux, , France

Site Status

Centre Regional Francois Baclesse

Caen, , France

Site Status

Centre Hospitalier General

Compiègne, , France

Site Status

Centre Georges-Francois Leclerc

Dijon, , France

Site Status

Centre Leon Berard

Lyon, , France

Site Status

Hopital Edouard Herriot

Lyon, , France

Site Status

Centre Antoine Lacassagne

Nice, , France

Site Status

Hotel Dieu de Paris

Paris, , France

Site Status

Hopital Saint Antoine

Paris, , France

Site Status

Hopital Cochin

Paris, , France

Site Status

Hopital Necker

Paris, , France

Site Status

Hopital Jules Courmont - Centre Hospitalier Lyon Sud

Pierre-Bénite, , France

Site Status

Hopital Sud

Rennes, , France

Site Status

Centre Henri Becquerel

Rouen, , France

Site Status

Centre Medico-Chirurgical Foch

Suresnes, , France

Site Status

Centre Alexis Vautrin

Vandœuvre-lès-Nancy, , France

Site Status

Institut Gustave Roussy

Villejuif, , France

Site Status

Zentralkrankenhaus

Bremen, , Germany

Site Status

Centro di Riferimento Oncologico - Aviano

Aviano, , Italy

Site Status

Dipartimente di Oncologia di Torino

Turin (Torino), , Italy

Site Status

Leyenburg Ziekenhuis

's-Gravenhage (Den Haag, the Hague), , Netherlands

Site Status

Groot Ziekengasthuis 's-Hertogenbosch

's-Hertogenbosch, , Netherlands

Site Status

Medisch Centrum Alkmaar

Alkmaar, , Netherlands

Site Status

Antoni van Leeuwenhoekhuis

Amsterdam, , Netherlands

Site Status

Integraal Kankercentrum Amsterdam

Amsterdam, , Netherlands

Site Status

Slotervaart Ziekenhuis

Amsterdam, , Netherlands

Site Status

Onze Lieve Vrouwe Gasthuis

Amsterdam, , Netherlands

Site Status

Streekziekenhuizen Gooi-Noord

Blaricum, , Netherlands

Site Status

Catharina Ziekenhuis

Eindhoven, , Netherlands

Site Status

Medisch Spectrum Twente

Enschede, , Netherlands

Site Status

De Wever Ziekenhuis

Heerlen, , Netherlands

Site Status

Radiotherapeutisch Instituut

Leeuwarden, , Netherlands

Site Status

Leiden University Medical Center

Leiden, , Netherlands

Site Status

Integraal Kankercentrum West

Leiden, , Netherlands

Site Status

Academisch Ziekenhuis Maastricht

Maastricht, , Netherlands

Site Status

St. Radboud University Hospital

Nijmegen, , Netherlands

Site Status

University Hospital - Rotterdam Dijkzigt

Rotterdam, , Netherlands

Site Status

Rotterdam Cancer Institute

Rotterdam, , Netherlands

Site Status

Sophia Ziekehuis

Zwolle, , Netherlands

Site Status

Maritime Hospital

Gdynia, , Poland

Site Status

Jagiellonian University

Krakow (Cracow), , Poland

Site Status

Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology

Warsaw, , Poland

Site Status

Hospitais da Universidade de Coimbra (HUC)

Coimbra, , Portugal

Site Status

Instituto Portugues de Oncologia de Francisco Gentil

Lisbon, , Portugal

Site Status

Instituto Portugues de Oncologia do Porto

Porto, , Portugal

Site Status

Institute of Oncology, Ljubljana

Ljubljana, , Slovenia

Site Status

Countries

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Belgium Egypt France Germany Italy Netherlands Poland Portugal Slovenia

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.

Reference Type RESULT
PMID: 17097834 (View on PubMed)

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.

Reference Type RESULT
PMID: 15936157 (View on PubMed)

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.

Reference Type RESULT

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.

Reference Type RESULT

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.

Reference Type RESULT

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.

Reference Type RESULT
PMID: 9187443 (View on PubMed)

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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