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

NCT00002462 | Active Not Recruiting Phase 3

• 1 other identifier: EORTC-20884
• Study Type: interventional
• Target: 615
• Locations: 9 countries
• Sites: 56

Brief 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.

Conditions

Lymphoma

Keywords

stage III adult Hodgkin lymphoma; stage IV adult Hodgkin lymphoma

Outcome Measures

Primary Outcomes (2)

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

• Efficacy of MOPP/ABV hybrid CT

Secondary Outcomes (2)

• Relapse free survival

• Overall survival

Interventions

bleomycin sulfate BIOLOGICAL

doxorubicin hydrochloride DRUG

mechlorethamine hydrochloride DRUG

prednisone DRUG

procarbazine hydrochloride DRUG

vinblastine sulfate DRUG

vincristine sulfate DRUG

low-LET cobalt-60 gamma ray therapy RADIATION

low-LET photon therapy RADIATION

radiation therapy RADIATION

Eligibility Criteria

• Age: 15 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• European Organisation for Research and Treatment of Cancer - EORTC: lead

Study Sites (56)

Algemeen Ziekenhuis Middelheim

Antwerp, 2020, Belgium

Location

A.Z. St. Jan

Bruges, 8000, Belgium

Location

Hopital Universitaire Erasme

Brussels, 1070, Belgium

Location

C.H.U. Saint-Pierre

Brussels (Bruxelles), 1000, Belgium

Location

Institut Jules Bordet

Brussels (Bruxelles), 1000, Belgium

Location

Centre Hospitalier Universitaire Brugmann

Brussels (Bruxelles), B 1020, Belgium

Location

Centre Hospitalier Universitaire de Tivoli

La Louvière, 7100, Belgium

Location

U.Z. Gasthuisberg

Leuven, B-3000, Belgium

Location

U.Z. Sint-Rafael

Leuven, B-3000, Belgium

Location

National Cancer Institute of Egypt

Cairo, Egypt

Location

Institut Bergonie

Bordeaux, 33076, France

Location

Centre Regional Francois Baclesse

Caen, 14076, France

Location

Centre Hospitalier General

Compiègne, 60321, France

Location

Centre Georges-Francois Leclerc

Dijon, 21034, France

Location

Centre Leon Berard

Lyon, 69373, France

Location

Hopital Edouard Herriot

Lyon, 69437, France

Location

Centre Antoine Lacassagne

Nice, 06189, France

Location

Hotel Dieu de Paris

Paris, 75181, France

Location

Hopital Saint Antoine

Paris, 75571, France

Location

Hopital Cochin

Paris, 75674, France

Location

Hopital Necker

Paris, 75743, France

Location

Hopital Jules Courmont - Centre Hospitalier Lyon Sud

Pierre-Bénite, 69495, France

Location

Hopital Sud

Rennes, 35056, France

Location

Centre Henri Becquerel

Rouen, 76038, France

Location

Centre Medico-Chirurgical Foch

Suresnes, 92151, France

Location

Centre Alexis Vautrin

Vandœuvre-lès-Nancy, 54511, France

Location

Institut Gustave Roussy

Villejuif, F-94805, France

Location

Zentralkrankenhaus

Bremen, D-28205, Germany

Location

Centro di Riferimento Oncologico - Aviano

Aviano, 33081, Italy

Location

Dipartimente di Oncologia di Torino

Turin (Torino), 10123, Italy

Location

Leyenburg Ziekenhuis

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

Location

Groot Ziekengasthuis 's-Hertogenbosch

's-Hertogenbosch, 5211 NL, Netherlands

Location

Medisch Centrum Alkmaar

Alkmaar, 1815 JD, Netherlands

Location

Antoni van Leeuwenhoekhuis

Amsterdam, 1066 CX, Netherlands

Location

Integraal Kankercentrum Amsterdam

Amsterdam, 1066 CX, Netherlands

Location

Slotervaart Ziekenhuis

Amsterdam, 1066 EC, Netherlands

Location

Onze Lieve Vrouwe Gasthuis

Amsterdam, 1091 HA, Netherlands

Location

Streekziekenhuizen Gooi-Noord

Blaricum, 1261 AN, Netherlands

Location

Catharina Ziekenhuis

Eindhoven, 5602 ZA, Netherlands

Location

Medisch Spectrum Twente

Enschede, 7500 KA, Netherlands

Location

De Wever Ziekenhuis

Heerlen, 6419 PC, Netherlands

Location

Radiotherapeutisch Instituut

Leeuwarden, 8934 AD, Netherlands

Location

Leiden University Medical Center

Leiden, 2300 ZA, Netherlands

Location

Integraal Kankercentrum West

Leiden, 2316 XB, Netherlands

Location

Academisch Ziekenhuis Maastricht

Maastricht, 6202 AZ, Netherlands

Location

St. Radboud University Hospital

Nijmegen, 6500 HB, Netherlands

Location

University Hospital - Rotterdam Dijkzigt

Rotterdam, 3000 CA, Netherlands

Location

Rotterdam Cancer Institute

Rotterdam, 3075 EA, Netherlands

Location

Sophia Ziekehuis

Zwolle, 8000 GK, Netherlands

Location

Maritime Hospital

Gdynia, PL-81--519, Poland

Location

Jagiellonian University

Krakow (Cracow), 31-826, Poland

Location

Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology

Warsaw, 02-781, Poland

Location

Hospitais da Universidade de Coimbra (HUC)

Coimbra, 3049, Portugal

Location

Instituto Portugues de Oncologia de Francisco Gentil

Lisbon, 1093, Portugal

Location

Instituto Portugues de Oncologia do Porto

Porto, 4200, Portugal

Location

Institute of Oncology, Ljubljana

Ljubljana, Sl-1000, Slovenia

Location

Related Publications (6)

• 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.

  PMID: 17097834 RESULT

• 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.

  PMID: 15936157 RESULT

• 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.

  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.

  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.

  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.

  PMID: 9187443 RESULT

MeSH Terms

Conditions

Lymphoma; Hodgkin Disease

Interventions

Bleomycin; Doxorubicin; Mechlorethamine; Prednisone; Procarbazine; Vinblastine; Vincristine; Radiotherapy

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Glycopeptides; Glycoconjugates; Carbohydrates; Peptides; Amino Acids, Peptides, and Proteins; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Benzamides; Amides; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Therapeutics

Study Officials

• John Raemaekers, MD, PhD

  Universitair Medisch Centrum St. Radboud - Nijmegen

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: July 26, 2004
• Study Start: September 1, 1989
• Primary Completion: May 1, 2000
• Last Updated: August 5, 2025

Record last verified: 2025-08

Locations

NL (19); BE (9); FR (17); PL (3); IT (2); DE (1); PT (3); SL (1); EG (1)