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

Primary Purpose

Lymphoma

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
bleomycin sulfate
doxorubicin hydrochloride
mechlorethamine hydrochloride
prednisone
procarbazine hydrochloride
vinblastine sulfate
vincristine sulfate
low-LET cobalt-60 gamma ray therapy
low-LET photon therapy
radiation therapy
Sponsored by
European Organisation for Research and Treatment of Cancer - EORTC
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphoma focused on measuring stage III adult Hodgkin lymphoma, stage IV adult Hodgkin lymphoma

Eligibility Criteria

15 Years - 70 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Algemeen Ziekenhuis Middelheim
  • A.Z. St. Jan
  • C.H.U. Saint-Pierre
  • Institut Jules Bordet
  • Centre Hospitalier Universitaire Brugmann
  • Hopital Universitaire Erasme
  • Centre Hospitalier Universitaire de Tivoli
  • U.Z. Gasthuisberg
  • U.Z. Sint-Rafael
  • National Cancer Institute of Egypt
  • Institut Bergonie
  • Centre Regional Francois Baclesse
  • Centre Hospitalier General
  • Centre Georges-Francois Leclerc
  • Centre Leon Berard
  • Hopital Edouard Herriot
  • Centre Antoine Lacassagne
  • Hotel Dieu de Paris
  • Hopital Saint Antoine
  • Hopital Cochin
  • Hopital Necker
  • Hopital Jules Courmont - Centre Hospitalier Lyon Sud
  • Hopital Sud
  • Centre Henri Becquerel
  • Centre Medico-Chirurgical Foch
  • Centre Alexis Vautrin
  • Institut Gustave Roussy
  • Zentralkrankenhaus
  • Centro di Riferimento Oncologico - Aviano
  • Dipartimente di Oncologia di Torino
  • Leyenburg Ziekenhuis
  • Groot Ziekengasthuis 's-Hertogenbosch
  • Medisch Centrum Alkmaar
  • Antoni van Leeuwenhoekhuis
  • Integraal Kankercentrum Amsterdam
  • Slotervaart Ziekenhuis
  • Onze Lieve Vrouwe Gasthuis
  • Streekziekenhuizen Gooi-Noord
  • Catharina Ziekenhuis
  • Medisch Spectrum Twente
  • De Wever Ziekenhuis
  • Radiotherapeutisch Instituut
  • Leiden University Medical Center
  • Integraal Kankercentrum West
  • Academisch Ziekenhuis Maastricht
  • St. Radboud University Hospital
  • University Hospital - Rotterdam Dijkzigt
  • Rotterdam Cancer Institute
  • Sophia Ziekehuis
  • Maritime Hospital
  • Jagiellonian University
  • Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology
  • Hospitais da Universidade de Coimbra (HUC)
  • Instituto Portugues de Oncologia de Francisco Gentil
  • Instituto Portugues de Oncologia do Porto
  • Institute of Oncology, Ljubljana

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Relapse free survival
Overall survival

Full Information

First Posted
November 1, 1999
Last Updated
February 14, 2023
Sponsor
European Organisation for Research and Treatment of Cancer - EORTC
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1. Study Identification

Unique Protocol Identification Number
NCT00002462
Brief Title
RT or No RT Following Chemotherapy in Treating Patients With Stage III/IV Hodgkin's Disease
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 1989 (Actual)
Primary Completion Date
May 2000 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
European Organisation for Research and Treatment of Cancer - EORTC

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma
Keywords
stage III adult Hodgkin lymphoma, stage IV adult Hodgkin lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Allocation
Randomized
Enrollment
615 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
bleomycin sulfate
Intervention Type
Drug
Intervention Name(s)
doxorubicin hydrochloride
Intervention Type
Drug
Intervention Name(s)
mechlorethamine hydrochloride
Intervention Type
Drug
Intervention Name(s)
prednisone
Intervention Type
Drug
Intervention Name(s)
procarbazine hydrochloride
Intervention Type
Drug
Intervention Name(s)
vinblastine sulfate
Intervention Type
Drug
Intervention Name(s)
vincristine sulfate
Intervention Type
Radiation
Intervention Name(s)
low-LET cobalt-60 gamma ray therapy
Intervention Type
Radiation
Intervention Name(s)
low-LET photon therapy
Intervention Type
Radiation
Intervention Name(s)
radiation therapy
Primary Outcome Measure Information:
Title
Benefit of adjuvant involved field RT after entering complete remission with MOPP/ABV hybrid CT
Title
Efficacy of MOPP/ABV hybrid CT
Secondary Outcome Measure Information:
Title
Relapse free survival
Title
Overall survival

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Raemaekers, MD, PhD
Organizational Affiliation
Universitair Medisch Centrum St. Radboud - Nijmegen
Official's Role
Study Chair
Facility Information:
Facility Name
Algemeen Ziekenhuis Middelheim
City
Antwerp
ZIP/Postal Code
2020
Country
Belgium
Facility Name
A.Z. St. Jan
City
Brugge
ZIP/Postal Code
8000
Country
Belgium
Facility Name
C.H.U. Saint-Pierre
City
Brussels (Bruxelles)
ZIP/Postal Code
1000
Country
Belgium
Facility Name
Institut Jules Bordet
City
Brussels (Bruxelles)
ZIP/Postal Code
1000
Country
Belgium
Facility Name
Centre Hospitalier Universitaire Brugmann
City
Brussels (Bruxelles)
ZIP/Postal Code
B 1020
Country
Belgium
Facility Name
Hopital Universitaire Erasme
City
Brussels
ZIP/Postal Code
1070
Country
Belgium
Facility Name
Centre Hospitalier Universitaire de Tivoli
City
La Louviere
ZIP/Postal Code
7100
Country
Belgium
Facility Name
U.Z. Gasthuisberg
City
Leuven
ZIP/Postal Code
B-3000
Country
Belgium
Facility Name
U.Z. Sint-Rafael
City
Leuven
ZIP/Postal Code
B-3000
Country
Belgium
Facility Name
National Cancer Institute of Egypt
City
Cairo
Country
Egypt
Facility Name
Institut Bergonie
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Facility Name
Centre Regional Francois Baclesse
City
Caen
ZIP/Postal Code
14076
Country
France
Facility Name
Centre Hospitalier General
City
Compiegne
ZIP/Postal Code
60321
Country
France
Facility Name
Centre Georges-Francois Leclerc
City
Dijon
ZIP/Postal Code
21034
Country
France
Facility Name
Centre Leon Berard
City
Lyon
ZIP/Postal Code
69373
Country
France
Facility Name
Hopital Edouard Herriot
City
Lyon
ZIP/Postal Code
69437
Country
France
Facility Name
Centre Antoine Lacassagne
City
Nice
ZIP/Postal Code
06189
Country
France
Facility Name
Hotel Dieu de Paris
City
Paris
ZIP/Postal Code
75181
Country
France
Facility Name
Hopital Saint Antoine
City
Paris
ZIP/Postal Code
75571
Country
France
Facility Name
Hopital Cochin
City
Paris
ZIP/Postal Code
75674
Country
France
Facility Name
Hopital Necker
City
Paris
ZIP/Postal Code
75743
Country
France
Facility Name
Hopital Jules Courmont - Centre Hospitalier Lyon Sud
City
Pierre Benite
ZIP/Postal Code
69495
Country
France
Facility Name
Hopital Sud
City
Rennes
ZIP/Postal Code
35056
Country
France
Facility Name
Centre Henri Becquerel
City
Rouen
ZIP/Postal Code
76038
Country
France
Facility Name
Centre Medico-Chirurgical Foch
City
Suresnes
ZIP/Postal Code
92151
Country
France
Facility Name
Centre Alexis Vautrin
City
Vandoeuvre-les-Nancy
ZIP/Postal Code
54511
Country
France
Facility Name
Institut Gustave Roussy
City
Villejuif
ZIP/Postal Code
F-94805
Country
France
Facility Name
Zentralkrankenhaus
City
Bremen
ZIP/Postal Code
D-28205
Country
Germany
Facility Name
Centro di Riferimento Oncologico - Aviano
City
Aviano
ZIP/Postal Code
33081
Country
Italy
Facility Name
Dipartimente di Oncologia di Torino
City
Turin (Torino)
ZIP/Postal Code
10123
Country
Italy
Facility Name
Leyenburg Ziekenhuis
City
's-Gravenhage (Den Haag, The Hague)
ZIP/Postal Code
2545 CH
Country
Netherlands
Facility Name
Groot Ziekengasthuis 's-Hertogenbosch
City
's-Hertogenbosch
ZIP/Postal Code
5211 NL
Country
Netherlands
Facility Name
Medisch Centrum Alkmaar
City
Alkmaar
ZIP/Postal Code
1815 JD
Country
Netherlands
Facility Name
Antoni van Leeuwenhoekhuis
City
Amsterdam
ZIP/Postal Code
1066 CX
Country
Netherlands
Facility Name
Integraal Kankercentrum Amsterdam
City
Amsterdam
ZIP/Postal Code
1066 CX
Country
Netherlands
Facility Name
Slotervaart Ziekenhuis
City
Amsterdam
ZIP/Postal Code
1066 EC
Country
Netherlands
Facility Name
Onze Lieve Vrouwe Gasthuis
City
Amsterdam
ZIP/Postal Code
1091 HA
Country
Netherlands
Facility Name
Streekziekenhuizen Gooi-Noord
City
Blaricum
ZIP/Postal Code
1261 AN
Country
Netherlands
Facility Name
Catharina Ziekenhuis
City
Eindhoven
ZIP/Postal Code
5602 ZA
Country
Netherlands
Facility Name
Medisch Spectrum Twente
City
Enschede
ZIP/Postal Code
7500 KA
Country
Netherlands
Facility Name
De Wever Ziekenhuis
City
Heerlen
ZIP/Postal Code
6419 PC
Country
Netherlands
Facility Name
Radiotherapeutisch Instituut
City
Leeuwarden
ZIP/Postal Code
8934 AD
Country
Netherlands
Facility Name
Leiden University Medical Center
City
Leiden
ZIP/Postal Code
2300 ZA
Country
Netherlands
Facility Name
Integraal Kankercentrum West
City
Leiden
ZIP/Postal Code
2316 XB
Country
Netherlands
Facility Name
Academisch Ziekenhuis Maastricht
City
Maastricht
ZIP/Postal Code
6202 AZ
Country
Netherlands
Facility Name
St. Radboud University Hospital
City
Nijmegen
ZIP/Postal Code
6500 HB
Country
Netherlands
Facility Name
University Hospital - Rotterdam Dijkzigt
City
Rotterdam
ZIP/Postal Code
3000 CA
Country
Netherlands
Facility Name
Rotterdam Cancer Institute
City
Rotterdam
ZIP/Postal Code
3075 EA
Country
Netherlands
Facility Name
Sophia Ziekehuis
City
Zwolle
ZIP/Postal Code
8000 GK
Country
Netherlands
Facility Name
Maritime Hospital
City
Gdynia
ZIP/Postal Code
PL-81--519
Country
Poland
Facility Name
Jagiellonian University
City
Krakow (Cracow)
ZIP/Postal Code
31-826
Country
Poland
Facility Name
Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology
City
Warsaw
ZIP/Postal Code
02-781
Country
Poland
Facility Name
Hospitais da Universidade de Coimbra (HUC)
City
Coimbra
ZIP/Postal Code
3049
Country
Portugal
Facility Name
Instituto Portugues de Oncologia de Francisco Gentil
City
Lisbon
ZIP/Postal Code
1093
Country
Portugal
Facility Name
Instituto Portugues de Oncologia do Porto
City
Porto
ZIP/Postal Code
4200
Country
Portugal
Facility Name
Institute of Oncology, Ljubljana
City
Ljubljana
ZIP/Postal Code
Sl-1000
Country
Slovenia

12. IPD Sharing Statement

Citations:
PubMed Identifier
17097834
Citation
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.
Results Reference
result
PubMed Identifier
15936157
Citation
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.
Results Reference
result
Citation
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.
Results Reference
result
Citation
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.
Results Reference
result
Citation
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.
Results Reference
result
PubMed Identifier
9187443
Citation
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.
Results Reference
result

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

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