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LymphomaPhase 3NCT00002462

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

A Phase 3 study testing bleomycin sulfate, doxorubicin hydrochloride and mechlorethamine hydrochloride in people with Lymphoma, run by European Organisation for Research and Treatment of Cancer - EORTC at 56 sites in 9 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 15 to 70 years
Conditions the study is for
Lymphoma
What is being tested?
bleomycin sulfate, doxorubicin hydrochloride and mechlorethamine hydrochloride
Type of treatment
Surgery or procedure
How many people
615 participants
Where
56 sitesin 9 countries
Study dates
Sep 1989to May 2000
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 15 to 70 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

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

Trial locations and contacts

56 sites in 9 countries.

56 sites in 9 countries

Netherlands19 sites

  • Leyenburg Ziekenhuis

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

  • Groot Ziekengasthuis 's-Hertogenbosch

    's-Hertogenbosch, 5211 NL

  • Medisch Centrum Alkmaar

    Alkmaar, 1815 JD

  • Antoni van Leeuwenhoekhuis

    Amsterdam, 1066 CX

  • Integraal Kankercentrum Amsterdam

    Amsterdam, 1066 CX

  • Slotervaart Ziekenhuis

    Amsterdam, 1066 EC

  • Onze Lieve Vrouwe Gasthuis

    Amsterdam, 1091 HA

  • Streekziekenhuizen Gooi-Noord

    Blaricum, 1261 AN

  • Catharina Ziekenhuis

    Eindhoven, 5602 ZA

  • Medisch Spectrum Twente

    Enschede, 7500 KA

  • De Wever Ziekenhuis

    Heerlen, 6419 PC

  • Radiotherapeutisch Instituut

    Leeuwarden, 8934 AD

  • Leiden University Medical Center

    Leiden, 2300 ZA

  • Integraal Kankercentrum West

    Leiden, 2316 XB

  • Academisch Ziekenhuis Maastricht

    Maastricht, 6202 AZ

  • St. Radboud University Hospital

    Nijmegen, 6500 HB

  • University Hospital - Rotterdam Dijkzigt

    Rotterdam, 3000 CA

  • Rotterdam Cancer Institute

    Rotterdam, 3075 EA

  • Sophia Ziekehuis

    Zwolle, 8000 GK

Other trials in Netherlands

France17 sites

  • Institut Bergonie

    Bordeaux, 33076

  • Centre Regional Francois Baclesse

    Caen, 14076

  • Centre Hospitalier General

    Compiègne, 60321

  • Centre Georges-Francois Leclerc

    Dijon, 21034

  • Centre Leon Berard

    Lyon, 69373

  • Hopital Edouard Herriot

    Lyon, 69437

  • Centre Antoine Lacassagne

    Nice, 06189

  • Hotel Dieu de Paris

    Paris, 75181

  • Hopital Saint Antoine

    Paris, 75571

  • Hopital Cochin

    Paris, 75674

  • Hopital Necker

    Paris, 75743

  • Hopital Jules Courmont - Centre Hospitalier Lyon Sud

    Pierre-Bénite, 69495

  • Hopital Sud

    Rennes, 35056

  • Centre Henri Becquerel

    Rouen, 76038

  • Centre Medico-Chirurgical Foch

    Suresnes, 92151

  • Centre Alexis Vautrin

    Vandœuvre-lès-Nancy, 54511

  • Institut Gustave Roussy

    Villejuif, F-94805

Other trials in France

Belgium9 sites

  • Algemeen Ziekenhuis Middelheim

    Antwerp, 2020

  • A.Z. St. Jan

    Bruges, 8000

  • Hopital Universitaire Erasme

    Brussels, 1070

  • C.H.U. Saint-Pierre

    Brussels (Bruxelles), 1000

  • Institut Jules Bordet

    Brussels (Bruxelles), 1000

  • Centre Hospitalier Universitaire Brugmann

    Brussels (Bruxelles), B 1020

  • Centre Hospitalier Universitaire de Tivoli

    La Louvière, 7100

  • U.Z. Gasthuisberg

    Leuven, B-3000

  • U.Z. Sint-Rafael

    Leuven, B-3000

Other trials in Belgium

Poland3 sites

  • Maritime Hospital

    Gdynia, PL-81--519

  • Jagiellonian University

    Krakow (Cracow), 31-826

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

    Warsaw, 02-781

Other trials in Poland

Portugal3 sites

  • Hospitais da Universidade de Coimbra (HUC)

    Coimbra, 3049

  • Instituto Portugues de Oncologia de Francisco Gentil

    Lisbon, 1093

  • Instituto Portugues de Oncologia do Porto

    Porto, 4200

Other trials in Portugal

Italy2 sites

  • Centro di Riferimento Oncologico - Aviano

    Aviano, 33081

  • Dipartimente di Oncologia di Torino

    Turin (Torino), 10123

Other trials in Italy

Egypt1 site

  • National Cancer Institute of Egypt

    Cairo

Other trials in Egypt

Germany1 site

  • Zentralkrankenhaus

    Bremen, D-28205

Other trials in Germany

Slovenia1 site

  • Institute of Oncology, Ljubljana

    Ljubljana, Sl-1000

Other trials in Slovenia

About this study

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

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.

Read the 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.

Conditions
Lymphoma
Being tested
bleomycin sulfate, doxorubicin hydrochloride, mechlorethamine hydrochloride, prednisone, procarbazine hydrochloride
Keywords
stage III adult Hodgkin lymphoma, stage IV adult Hodgkin lymphoma
Medical subject headings
Lymphoma, Hodgkin Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • bleomycin sulfateBiological

  • doxorubicin hydrochlorideDrug

  • mechlorethamine hydrochlorideDrug

  • prednisoneDrug

  • procarbazine hydrochlorideDrug

  • vinblastine sulfateDrug

  • vincristine sulfateDrug

  • low-LET cobalt-60 gamma ray therapyRadiation

  • low-LET photon therapyRadiation

  • radiation therapyRadiation

What is being measured

The primary outcome is the main question the study is designed to answer.

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

  2. Efficacy of MOPP/ABV hybrid CT

Secondary outcomes (2)

  1. Relapse free survival

  2. Overall survival

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jul 2004 (estimated)
  2. Study startSep 1989
  3. Primary completionMay 2000

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Enrolment
615 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00002462
Sponsor's protocol ID
EORTC-20884
Other IDs
EORTC-20884
Status last verified
Aug 2025
First submitted
1 Nov 1999
Last updated
5 Aug 2025
Results posted
No

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.

    PubMed 17097834

  • 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.

    PubMed 15936157

  • 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.

    PubMed 9187443

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing bleomycin sulfate, doxorubicin hydrochloride and mechlorethamine hydrochloride in people with Lymphoma, run by European Organisation for Research and Treatment of Cancer - EORTC at 56 sites in 9 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 5 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 56 sites in Netherlands, France, Belgium, Poland, Portugal and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Benefit of adjuvant involved field RT after entering complete remission with MOPP/ABV hybrid CT. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00002462, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2025.

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