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Trial registered on ANZCTR
Registration number
ACTRN12618000069257
Ethics application status
Approved
Date submitted
13/12/2016
Date registered
17/01/2018
Date last updated
14/02/2023
Date data sharing statement initially provided
11/02/2020
Type of registration
Retrospectively registered
Titles & IDs
Public title
European Network-Paediatric Hodgkin Lymphoma Study Group: Second International Inter-Group Study for Classical Hodgkin Lymphoma in Children and Adolescents
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Scientific title
EuroNet-PHL-C2: international, multicentre, randomised controlled trial for the first line treatment of classical Hodgkin`s Lymphoma in children and adolescents to individualise treatment (risk stratified chemotherapy and response adapted radiotherapy) and decrease long-term complications.
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Secondary ID [1]
290736
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NCT02684708
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Secondary ID [2]
290737
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EUCTR2012-004053-88-BE
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Universal Trial Number (UTN)
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Trial acronym
EuroNet-PHL-C2
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Classical Hodgkin Lymphoma
301316
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Condition category
Condition code
Cancer
301070
301070
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0
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Hodgkin's
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Patients are assigned to treatment levels (TL) according to stage, tumour size and blood ESR values.
Group 1: Treatment level 1
2 x 28 day cycles of OEPA chemotherapy (OEPA: Prednisone/Prednisolone: 60 mg/m2/day orally, on days 1-15 + Vincristine: 1.5 mg/m2 i.v., on day 1, 8 and 15 + Doxorubicin: 40 mg/m2 i.v., day 1 and 15 + Etoposide/Etopophos: 125 mg/m2 Etoposide; i.v., day 1 – 5)
Patients with an adequate response via PET scan (ie. PET Deauville Score of 1, 2 or 3), receive 1 x 28 day cycle of COPDAC28 (COPDAC28 = Prednisone/Prednisolone: 40 mg/m2/day orally, on days 1-15 + Dacarbazine 250 mg/m2 i.v., day 1 – 3 + Vincristine: 1.5 mg/m2 i.v., on day 1 and 8 + Cyclophosphamide 500 mg/m2, i.v., day 1 + 8), beginning 1-2 weeks post OEPA.
Patients with an inadequate response via PET scan (ie. PET Deauville Score of 4 or 5) will receive involved node radiotherapy to all initially involved sites (19.8 Gy in 11 fractions given at 1 fraction daily for 5 days per week (1.8 Gy per fraction)) at 2-4 weeks post OEPA.
There is no randomisation in TL-1.
Group 2: Treatment Level 2 and 3 with an adequate early PET Response
All patients receive 2 cycles of OEPA (as above).
Patients with an adequate response via PET scan undergo randomisation between COPDAC28 (standard therapy, as above) or DECOPDAC21 (experimental: 21 day cycles of Prednisone/Prednisolone 40 mg/m2/day, orally on days 1 – 8 + Dacarbazine 250 mg/m2 i.v., day 1 – 3 + Vincristine: 1.5 mg/m2 i.v., on day 1 and 8 + Cyclophosphamide 625 mg/m2, i.v., day 1 and 2 + Etoposide/Etopophos 100 mg/m2/day i.v. on day 1-3 + Doxorubicin
25 mg/m2 i.v. on day 1).
Patients in TL2 receive 2 cycles of COPDAC28 or DECOPDAC21 and patients in TL3 receive 4 cycles of COPDAC28 or DECOPDAC21. Patients do not receive radiotherapy.
Group 3: Treatment Level 2 and 3 with an inadequate Early PET Response
All patients receive 2 cycles of OEPA (as above).
Patients with an inadequate response via PET scan undergo randomisation between
COPDAC28 (standard therapy) or DECOPDAC21 (experimental), as above.
Patients in TL2 receive 2 cycles of COPDAC28 or DECOPDAC21 and patients in TL3 receive 4 cycles of COPDAC28 or DECOPDAC21.
Patients receiving COPDAC28 are followed with standard involved node radiotherapy to all initially involved sites (19.8 Gy in 11 fractions (1.8 Gy per fraction), and a boost (10 Gy in 5 fractions (2 Gy per fraction)) to late response assessment (LRA) FDG-PET positive residuals. Patients who receive the intensified DECOPDAC21 chemotherapy will also receive radiotherapy to LRA FDG-PET positive sites only (28.8 Gy in 16 fractions given at 1 fraction daily for 5 days per week (1.8 Gy per fraction).
Intravenous drugs will be administered in hospital. Participants and their families will be asked to complete a medication diary to record oral medication usage.
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Intervention code [1]
296638
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Treatment: Drugs
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Intervention code [2]
296639
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Treatment: Other
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Comparator / control treatment
Active Comparator: COPDAC-28
Drugs and Dose: Cyclophosphamide 500 mg/m2,i.v., on day 1 + 8; vincristine 1.5 mg/m2 i.v., on day 1 and 8; prednisone 40 mg/m2/day orally on day 1 - 15; dacarbazine 250 mg/m2 i.v., on day 1-3.
Length of cycle: 28 days
Duration of treatment varies according to treatment level and the patient’s response (TL-2 COPDAC-28 arm, 16-20 weeks and TL-3 COPDAC-28 arm 20-24 weeks)
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Control group
Active
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Outcomes
Primary outcome [1]
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Event-free survival (EFS) defined as time from start of treatment until the first of the following events: progression/relapse of disease (assessed by histological confirmation of biopsy of suspected lesion), secondary malignancy or death from any cause.
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Assessment method [1]
300492
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Timepoint [1]
300492
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5 years
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Secondary outcome [1]
330090
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Overall Survival: defined as time from start of treatment until death from any cause
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Assessment method [1]
330090
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Timepoint [1]
330090
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5 years
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Secondary outcome [2]
330092
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Progression Free Survival: defined as time from start of treatment until progression/relapse of disease assessed by histological confirmation of biopsy of suspected lesion
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Assessment method [2]
330092
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Timepoint [2]
330092
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5 years
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Secondary outcome [3]
330102
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Serious adverse event rates: Common toxicity criteria grading during any individual treatment element, including assessment of osteonecrosis, according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
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Assessment method [3]
330102
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Timepoint [3]
330102
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5 years
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Eligibility
Key inclusion criteria
1. Histologically confirmed primary diagnosis of classical Hodgkin’s lymphoma
2. Patients under 18 years of age on the date of written informed consent (In specialised Teenage and Young Adult units in Australia, France, Italy, New Zealand and UK patients under 25 years of age can also be enrolled.). Lower age limits will be country specific according to national laws or formal insurance requirements that may preclude very young patients.
3. Written informed consent of the patient and/or the patient’s parents or guardian according to national laws
4. Negative pregnancy test within 2 weeks prior to starting treatment for female patients with childbearing potential.
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Minimum age
No limit
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Maximum age
24
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. Prior chemotherapy or radiotherapy for other malignancies
2. Pre-treatment of Hodgkin’s lymphoma (except for steroid pre-phase to a maximum of 7-10 days for emergency treatment of a large mediastinal tumour)
3. Diagnosis of lymphocyte-predominant Hodgkin’s lymphoma
4. Other (simultaneous) malignancies
5. Contraindication or known hypersensitivity to study drugs
6. Severe concomitant diseases (e.g. immune deficiency syndrome)
7. Known HIV-positivity
8. Residence outside the participating countries where long term follow-up cannot be guaranteed
9. Pregnancy and/or lactation
10. Patients who are sexually active and are unwilling to use adequate contraception during therapy and for one month after last trial treatment
11. Current or recent (within 30 days prior to date of written informed consent) treatment with another investigational drug or participation in another interventional clinical trial
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by Fax
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation of patients between COPDAC-28 and DECOPDAC-21 is performed centrally with a modified minimisation procedure with stochastic component according to Pocock (1983) in a 1:1 proportion.
Randomisation will be balanced according to the following criteria:
1. TL (TL-2 versus TL-3)
2. Countries
3. Trial site
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
Safety/efficacy
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Statistical methods / analysis
TL-1: Sample size of 431; >80% power to detect if the treatment strategy has 5 year EFS rates above 90%.
TL2 and 3 who have an adequate response at early response assessment: Sample size of 1345 patients; 84% power to detect an increase in 5-year EFS rates from 88% to 93% at a two-sided significance level of a = 5%.
TL2 and 3 who have an adequate response at early response assessment: Sample size 424; This study is aiming for comparable efficacy (EFS) with less toxicity. Assuming equality of EFS in both arms (log hazard ratio = 0) and a standard error of .26 there is > 84% power to show that arms are comparable.
The proportion of the cohort enrolled at Australian and New Zealand sites is expected to be 5% of the above targets.
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Recruitment
Recruitment status
Active, not recruiting
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Date of first participant enrolment
Anticipated
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Actual
23/03/2015
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Date of last participant enrolment
Anticipated
1/09/2021
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Actual
24/11/2020
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Date of last data collection
Anticipated
24/11/2025
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Actual
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Sample size
Target
160
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Accrual to date
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Final
149
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,TAS,WA,VIC
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Recruitment hospital [1]
7109
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The Royal Childrens Hospital - Parkville
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Recruitment hospital [2]
7110
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Sydney Children's Hospital - Randwick
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Recruitment hospital [3]
7111
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The Children's Hospital at Westmead - Westmead
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Recruitment hospital [4]
7112
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John Hunter Children's Hospital - New Lambton
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Recruitment hospital [5]
7113
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Lady Cilento Children's Hospital - South Brisbane
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Recruitment hospital [6]
7119
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Womens and Childrens Hospital - North Adelaide
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Recruitment hospital [7]
7120
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Princess Margaret Hospital - Subiaco
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Recruitment hospital [8]
7121
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Monash Medical Centre - Clayton campus - Clayton
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Recruitment hospital [9]
15848
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Royal Hobart Hospital - Hobart
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Recruitment hospital [10]
15849
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Perth Children's Hospital - Nedlands
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Recruitment hospital [11]
15850
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Queensland Children's Hospital - South Brisbane
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Recruitment postcode(s) [1]
14870
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2031 - Randwick
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Recruitment postcode(s) [2]
14871
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2145 - Westmead
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Recruitment postcode(s) [3]
14872
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2305 - New Lambton
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Recruitment postcode(s) [4]
14869
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3052 - Parkville
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Recruitment postcode(s) [5]
14881
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3168 - Clayton
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Recruitment postcode(s) [6]
14873
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4101 - South Brisbane
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Recruitment postcode(s) [7]
14879
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5006 - North Adelaide
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Recruitment postcode(s) [8]
14880
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6008 - Subiaco
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Recruitment postcode(s) [9]
29299
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6009 - Nedlands
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Recruitment postcode(s) [10]
29298
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7000 - Hobart
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Recruitment outside Australia
Country [1]
8479
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Germany
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State/province [1]
8479
0
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Country [2]
8480
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Austria
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State/province [2]
8480
0
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Country [3]
8481
0
New Zealand
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State/province [3]
8481
0
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Country [4]
8482
0
Belgium
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State/province [4]
8482
0
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Country [5]
8483
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Czech Republic
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State/province [5]
8483
0
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Country [6]
8484
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Denmark
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State/province [6]
8484
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Country [7]
8485
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Finland
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State/province [7]
8485
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Country [8]
8486
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France
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State/province [8]
8486
0
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Country [9]
8487
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Hungary
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State/province [9]
8487
0
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Country [10]
8488
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Ireland
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State/province [10]
8488
0
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Country [11]
8489
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Israel
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State/province [11]
8489
0
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Country [12]
8490
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Italy
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State/province [12]
8490
0
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Country [13]
8491
0
Netherlands
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State/province [13]
8491
0
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Country [14]
8492
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Norway
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State/province [14]
8492
0
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Country [15]
8493
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Poland
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State/province [15]
8493
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Country [16]
8494
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Portugal
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State/province [16]
8494
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Country [17]
8495
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Slovenia
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State/province [17]
8495
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Country [18]
8497
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Spain
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State/province [18]
8497
0
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Country [19]
8498
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Switzerland
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State/province [19]
8498
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Country [20]
8499
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United Kingdom
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State/province [20]
8499
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Funding & Sponsors
Funding source category [1]
295167
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Charities/Societies/Foundations
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Name [1]
295167
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My Room - Children's Cancer Charity
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Address [1]
295167
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SUITE 3, 400 HIGH STREET, KEW VIC 3101
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Country [1]
295167
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Australia
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Primary sponsor type
University
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Name
Justus Liebig University of Giessen
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Address
Rudolf-Buchheim-Str. 23
35392 Giessen
Germany
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Country
Germany
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Secondary sponsor category [1]
293991
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Other Collaborative groups
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Name [1]
293991
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Australia & New Zealand Children's Haematology/Oncology Group (ANZCHOG)
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Address [1]
293991
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27-31 Wright St
Clayton
VIC 3168
Australia
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Country [1]
293991
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
296517
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RCH Human Research Ethics Committee
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Ethics committee address [1]
296517
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Research Ethics & Governance The Royal Children's Hospital Level 4, South Building 50 Flemington Road Parkville Vic 3052
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Ethics committee country [1]
296517
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Australia
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Date submitted for ethics approval [1]
296517
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11/11/2015
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Approval date [1]
296517
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04/03/2016
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Ethics approval number [1]
296517
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HREC/15/RCHM/114
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Ethics committee name [2]
299368
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Ethics Commission of the Medical Faculty of the Martin-Luther-University Halle-Wittenberg
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Ethics committee address [2]
299368
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Ethics Committee of the Medical Faculty of the Martin-Luther-University Halle-Wittenberg 06097 Halle (Saale)
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Ethics committee country [2]
299368
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Germany
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Date submitted for ethics approval [2]
299368
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Approval date [2]
299368
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18/02/2015
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Ethics approval number [2]
299368
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2015-12
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Summary
Brief summary
This aim of this international, multicentre trial is to evaluate the safety and efficacy of a comprehensive first line treatment strategy for paediatric and adolescent patients with Classical Hodgkin Lymphoma (cHL). Who is it for? You may be eligible to join this study if you are aged less than 25 years and have a histologically confirmed primary diagnosis of classical Hodgkin’s lymphoma (cHL). Study details Based on risk factors at diagnosis, patient will be considered either low risk (TL-1), intermediate risk (TL-2) or advanced risk (TL-3) cHL. All patients initially receive 2 x 28 day cycles of the chemotherapy combination OEPA (Prednisone/Prednisolone, Vincristine, Doxorubicin and Etoposide/Etopophos). The response to OEPA treatment is measured using FDG-PET imaging and the next phase of treatment is determined. Treatment may include chemotherapy combinations called COPDAC-28 (consists of Prednisone/Prednisolone, Dacarbazine, Vincristine and Cyclophosphamide in a 28 day cycle) or DECOPDAC-21 (consists of Prednisone/Prednisolone, Dacarbazine, Vincristine and Cyclophosphamide, Etoposide/Etopophos and Doxorubicin in a 21 day cycle). Depending on risk level and response to treatment, patients may also be treated with Radiation Therapy. Patients in TL-2 and TL-3 will be randomly allocated to receive either the standard chemotherapy arm (COPDAC-28) or the experimental intensified chemotherapy arm (DECOPDAC-21). Patient response to therapy will be monitored using imaging and clinical exams for 5 years following completion of treatment. It is hoped that this study will maintain or improve survival while decreasing long term complications.
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Trial website
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Trial related presentations / publications
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Public notes
The sample sizes in this form relate to sites in Australia/New Zealand only.
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Contacts
Principal investigator
Name
71126
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Dr Leanne Super
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Address
71126
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Level 2 East Building,
Children’s Cancer Centre
The Royal Children’s Hospital
50 Flemington Road
Parkville, Victoria, 3052, AUS
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Country
71126
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Australia
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Phone
71126
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+61 3 9345 5612
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Fax
71126
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+61 3 9345 5510
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Email
71126
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leanne.super@rch.org.au
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Contact person for public queries
Name
71127
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Allison Lamb
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Address
71127
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Level 2 East Building,
Children’s Cancer Centre
The Royal Children’s Hospital
50 Flemington Road
Parkville, Victoria, 3052, AUS
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Country
71127
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Australia
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Phone
71127
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+61 3 9345 4989
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Fax
71127
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+61 3 9345 5510
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Email
71127
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allison.lamb@rch.org.au
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Contact person for scientific queries
Name
71128
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Michael Sullivan
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Address
71128
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Level 2 East Building,
Children’s Cancer Centre
The Royal Children’s Hospital
50 Flemington Road
Parkville, Victoria, 3052, AUS
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Country
71128
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Australia
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Phone
71128
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+61 3 9345 5820
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Fax
71128
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+61 3 9345 5510
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Email
71128
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michael.sullivan@rch.org.au
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
Aggregate results will be made available publicly
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
Download to PDF