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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00049595




Registration number
NCT00049595
Ethics application status
Date submitted
12/11/2002
Date registered
27/01/2003
Date last updated
9/11/2023

Titles & IDs
Public title
Comparison of Two Combination Chemotherapy Regimens in Treating Patients With Stage III or Stage IV Hodgkin's Lymphoma
Scientific title
BEACOPP (4 Cycles Escalated + 4 Cycles Baseline) Versus ABVD (8 Cycles) In Stage III & IV Hodgkin's Lymphoma
Secondary ID [1] 0 0
EORTC-20012
Secondary ID [2] 0 0
EORTC-20012
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lymphoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
Cancer 0 0 0 0
Hodgkin's

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - bleomycin sulfate
Other interventions - filgrastim
Other interventions - pegfilgrastim
Treatment: Drugs - ABVD regimen
Treatment: Drugs - BEACOPP regimen
Treatment: Drugs - cyclophosphamide
Treatment: Drugs - dacarbazine
Treatment: Drugs - doxorubicin hydrochloride
Treatment: Drugs - etoposide
Treatment: Drugs - prednisone
Treatment: Drugs - procarbazine hydrochloride
Treatment: Drugs - vinblastine sulfate
Treatment: Drugs - vincristine sulfate

Active Comparator: ABVD - 8 cycles of ABVD

Experimental: BEACOPP - 4 cycles of BEACOPP Escalated + 4 cycles of BEACOPP Baseline


Other interventions: bleomycin sulfate


Other interventions: filgrastim


Other interventions: pegfilgrastim


Treatment: Drugs: ABVD regimen


Treatment: Drugs: BEACOPP regimen


Treatment: Drugs: cyclophosphamide


Treatment: Drugs: dacarbazine


Treatment: Drugs: doxorubicin hydrochloride


Treatment: Drugs: etoposide


Treatment: Drugs: prednisone


Treatment: Drugs: procarbazine hydrochloride


Treatment: Drugs: vinblastine sulfate


Treatment: Drugs: vincristine sulfate
Intervention code [1] 0 0
Other interventions
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Event-free survival
Timepoint [1] 0 0
from randomization to early discontinuation of protocol treatment, no CR/CRu after 8 cycles, relapse, progression or death
Secondary outcome [1] 0 0
Complete response as assessed by Cheson criteria adapted to Hodgkin's lymphoma
Timepoint [1] 0 0
from randomization till end of treatment
Secondary outcome [2] 0 0
Disease-free survival in patients with complete response
Timepoint [2] 0 0
from the day of first documentation of CR to the day of relapse
Secondary outcome [3] 0 0
Overall survival
Timepoint [3] 0 0
from the date of randomization to the date of death
Secondary outcome [4] 0 0
Quality of life as assessed by European Organization for Research of the Treatment of Cancer (EORTC) Quality of Life Questionnaire (QoLQ) C30 version 3.0
Timepoint [4] 0 0
from one week prior to randomization till 10 years after end of treatment or death

Eligibility
Key inclusion criteria
DISEASE CHARACTERISTICS:

- Histologically confirmed Hodgkin's lymphoma

- No lymphocyte predominant, nodular type (nodular paragranuloma)

- Clinical stage III or IV disease

- At least 1 bidimensionally measurable target lesion or extranodal lesion

- International Prognostic Score of at least 3

PATIENT CHARACTERISTICS:

Age

- 16 to 60

Performance status

- WHO 0-2

Life expectancy

- Not specified

Hematopoietic

- WBC greater than 2,000/mm^3

- Platelet count greater than 100,000/mm^3

Hepatic

- No prior uncontrolled hepatitis B viral infection

- Bilirubin no greater than 2.5 times normal (unless due to Hodgkin's lymphoma)

Renal

- Creatinine no greater than 2.0 mg/dL (unless due to Hodgkin's lymphoma)

Cardiovascular

- No severe cardiac disease that would limit normal life expectancy or preclude study

- LVEF at least 50%

Pulmonary

- No severe pulmonary disease that would limit normal life expectancy or preclude study

- Respiratory function at least 30%

Other

- HIV negative

- HTLV1 negative

- No severe active infection

- No severe neurological or metabolic disease that would limit normal life expectancy or
preclude study

- No other prior or concurrent malignancy except basal cell skin cancer or carcinoma in
situ of the cervix

- No psychological, familial, sociological, or geographical condition that would
preclude study

- Not pregnant or nursing

- Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy

- Not specified

Chemotherapy

- Not specified

Endocrine therapy

- Not specified

Radiotherapy

- No concurrent radiotherapy

Surgery

- Not specified

Other

- No prior therapy for Hodgkin's lymphoma
Minimum age
16 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/08/2002
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
552
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
Canberra Hospital - Garran
Recruitment hospital [2] 0 0
Nepean Cancer Care Centre at Nepean Hospital - Kingswood
Recruitment hospital [3] 0 0
Westmead Institute for Cancer Research at Westmead Hospital - Westmead
Recruitment hospital [4] 0 0
Princess Alexandra Hospital - Brisbane
Recruitment hospital [5] 0 0
Peter MacCallum Cancer Centre - East Melbourne
Recruitment hospital [6] 0 0
St. Vincent's Hospital - Melbourne - Fitzroy
Recruitment hospital [7] 0 0
Royal Perth Hospital - Perth
Recruitment postcode(s) [1] 0 0
2606 - Garran
Recruitment postcode(s) [2] 0 0
2747 - Kingswood
Recruitment postcode(s) [3] 0 0
2145 - Westmead
Recruitment postcode(s) [4] 0 0
4102 - Brisbane
Recruitment postcode(s) [5] 0 0
3002 - East Melbourne
Recruitment postcode(s) [6] 0 0
3065 - Fitzroy
Recruitment postcode(s) [7] 0 0
6000 - Perth
Recruitment outside Australia
Country [1] 0 0
Belgium
State/province [1] 0 0
Antwerp
Country [2] 0 0
Belgium
State/province [2] 0 0
Brugge
Country [3] 0 0
Belgium
State/province [3] 0 0
Brussels
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Belgium
State/province [4] 0 0
Charleroi
Country [5] 0 0
Belgium
State/province [5] 0 0
Edegem
Country [6] 0 0
Belgium
State/province [6] 0 0
Ghent
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Belgium
State/province [7] 0 0
Haine Saint Paul
Country [8] 0 0
Belgium
State/province [8] 0 0
Leuven
Country [9] 0 0
Belgium
State/province [9] 0 0
Liege
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Belgium
State/province [10] 0 0
Roeselare
Country [11] 0 0
Belgium
State/province [11] 0 0
Yvoir
Country [12] 0 0
Canada
State/province [12] 0 0
Alberta
Country [13] 0 0
Canada
State/province [13] 0 0
Manitoba
Country [14] 0 0
Canada
State/province [14] 0 0
New Brunswick
Country [15] 0 0
Canada
State/province [15] 0 0
Newfoundland and Labrador
Country [16] 0 0
Canada
State/province [16] 0 0
Nova Scotia
Country [17] 0 0
Canada
State/province [17] 0 0
Ontario
Country [18] 0 0
Canada
State/province [18] 0 0
Quebec
Country [19] 0 0
Canada
State/province [19] 0 0
Saskatchewan
Country [20] 0 0
Croatia
State/province [20] 0 0
Zagreb
Country [21] 0 0
Czechia
State/province [21] 0 0
Prague
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France
State/province [22] 0 0
Annecy
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France
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Bayonne
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France
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Besancon
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France
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Bordeaux
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France
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Boucher
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France
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Bourg En Bresse
Country [28] 0 0
France
State/province [28] 0 0
Caen
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France
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Chambery
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France
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Clamart
Country [31] 0 0
France
State/province [31] 0 0
Clermont-Ferrand
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Colmar
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Corbeil
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Creteil
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Dijon
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France
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Grenoble
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France
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Le Chesnay
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France
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Lille
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France
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Limoges
Country [40] 0 0
France
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Lyon
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France
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Marseille
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France
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Meaux
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Melun
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France
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Metz
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France
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Montpellier
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Mulhouse
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France
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Nice
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France
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Paris
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France
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Pessac
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France
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Pierre Benite
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France
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Pontoise
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France
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Reims
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France
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Rennes
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France
State/province [54] 0 0
Rouen
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France
State/province [55] 0 0
Saint Cloud
Country [56] 0 0
France
State/province [56] 0 0
Saint Etienne
Country [57] 0 0
France
State/province [57] 0 0
Saint Germain-en-Laye
Country [58] 0 0
France
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Strasbourg
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France
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Suresnes
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France
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Valence
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France
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Valenciennes
Country [62] 0 0
France
State/province [62] 0 0
Vandoeuvre-Les-Nancy
Country [63] 0 0
France
State/province [63] 0 0
Villejuif
Country [64] 0 0
Hungary
State/province [64] 0 0
Budapest
Country [65] 0 0
Netherlands
State/province [65] 0 0
's-Gravenhage
Country [66] 0 0
Netherlands
State/province [66] 0 0
's-Hertogenbosch
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Netherlands
State/province [67] 0 0
Amersfoort
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Netherlands
State/province [68] 0 0
Amsterdam
Country [69] 0 0
Netherlands
State/province [69] 0 0
Delft
Country [70] 0 0
Netherlands
State/province [70] 0 0
Enschede
Country [71] 0 0
Netherlands
State/province [71] 0 0
Groningen
Country [72] 0 0
Netherlands
State/province [72] 0 0
Heerlen
Country [73] 0 0
Netherlands
State/province [73] 0 0
Leiden
Country [74] 0 0
Netherlands
State/province [74] 0 0
Maastricht
Country [75] 0 0
Netherlands
State/province [75] 0 0
Nijmegen
Country [76] 0 0
Netherlands
State/province [76] 0 0
Roermond
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Netherlands
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Rotterdam
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Netherlands
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Utrecht
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New Zealand
State/province [79] 0 0
Auckland
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New Zealand
State/province [80] 0 0
Hamilton
Country [81] 0 0
Poland
State/province [81] 0 0
Warsaw
Country [82] 0 0
Spain
State/province [82] 0 0
Barcelona
Country [83] 0 0
Sweden
State/province [83] 0 0
Gothenburg (Goteborg)
Country [84] 0 0
Sweden
State/province [84] 0 0
Linkoping
Country [85] 0 0
Sweden
State/province [85] 0 0
Lund
Country [86] 0 0
Sweden
State/province [86] 0 0
Stockholm
Country [87] 0 0
Sweden
State/province [87] 0 0
Umea
Country [88] 0 0
Sweden
State/province [88] 0 0
Uppsala
Country [89] 0 0
United Kingdom
State/province [89] 0 0
England

Funding & Sponsors
Primary sponsor type
Other
Name
European Organisation for Research and Treatment of Cancer - EORTC
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Lymphoma Trials Office
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Lymphoma Study Association
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Grup per l'Estudi dels Limfomes de Catalunya i Balears
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
NCIC Clinical Trials Group
Address [4] 0 0
Country [4] 0 0
Other collaborator category [5] 0 0
Other
Name [5] 0 0
Australasian Leukaemia and Lymphoma Group
Address [5] 0 0
Country [5] 0 0
Other collaborator category [6] 0 0
Other
Name [6] 0 0
Nordic Lymphoma Group
Address [6] 0 0
Country [6] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing
so they stop growing or die. Combining more than one drug may kill more cancer cells. It is
not yet known which combination chemotherapy regimen is more effective in treating stage III
or stage IV Hodgkin's lymphoma.

PURPOSE: Randomized phase III trial to compare the effectiveness of two combination
chemotherapy regimens in treating patients who have stage III or stage IV Hodgkin's lymphoma.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00049595
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Patrice P. Carde, MD
Address 0 0
Gustave Roussy, Cancer Campus, Grand Paris
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00049595