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

August 4, 2025 updated by: European Organisation for Research and Treatment of Cancer - EORTC

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Lymphoma

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

615

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 70 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Benefit of adjuvant involved field RT after entering complete remission with MOPP/ABV hybrid CT
Efficacy of MOPP/ABV hybrid CT

Secondary Outcome Measures

Outcome Measure
Overall survival
Relapse free survival

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

European Organisation for Research and Treatment of Cancer - EORTC

Investigators

Study Chair: John Raemaekers, MD, PhD, Universitair Medisch Centrum St. Radboud - Nijmegen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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.
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.
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.
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.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 1989

Primary Completion (Actual)

May 1, 2000

Study Registration Dates

First Submitted

November 1, 1999

First Submitted That Met QC Criteria

July 23, 2004

First Posted (Estimated)

July 26, 2004

Study Record Updates

Last Update Posted (Actual)

August 5, 2025

Last Update Submitted That Met QC Criteria

August 4, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

EORTC-20884 (Other Identifier: EORTC)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.