Second International Inter-Group Study for Classical Hodgkin Lymphoma in Children and Adolescents
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|ClinicalTrials.gov Identifier: NCT02684708|
Recruitment Status : Recruiting
First Posted : February 18, 2016
Last Update Posted : December 5, 2016
|Condition or disease||Intervention/treatment||Phase|
|Classical Hodgkin Lymphoma||Drug: cyclophosphamide, vincristine, prednisone, dacarbazine Drug: cyclo, vcr, pred, dacarb,etop and doxo||Phase 3|
EuroNet-PHL-C2 is a comprehensive treatment strategy for all first line classical Hodgkin Lymphoma (cHL) patients under 18 years (under 25 years in UK, Italy and France). The overall strategy is risk stratified (defining chemotherapy) and response adapted (defining radiotherapy) to tailor the amount of treatment to the individual patient and decrease long term complications.
- Radiotherapy indication will be restricted. Patients with a negative PET scan after two cycles of OEPA chemotherapy (Early Response Assessment - ERA) will not receive radiotherapy. The threshold for negative PET scan at ERA shifts from the previously used Deauville 1 and 2 = negative (as in the C1 trial) to Deauville 1, 2 and 3 = negative, thereby increasing the number of negative patients without indication for RT.
- Chemotherapy Randomisation
All intermediate (TL-2) and advanced stage (TL-3) patients will be randomised between respectively 2 or 4 standard COPDAC-28 or intensified DECOPDAC-21 consolidation chemotherapy cycles. To avoid delayed consolidation, randomisation has to be performed before ERA and as soon as the TL-assignment is confirmed by central review. Therefore two randomised sub-studies arise based on the ERA PET response:
Patients with adequate response at ERA do not receive radiotherapy - a randomised controlled chemotherapy comparison to show that intensified DECOPDAC-21 consolidation chemotherapy improves EFS as compared to standard COPDAC-28
Patients with inadequate response at ERA - a randomised controlled chemotherapy-radiotherapy comparison - to show that DECOPDAC-21 combined with radiotherapy restricted to sites that remain FDG-PET positive at the end of all chemotherapy (Late response assessment - LRA) has comparable EFS compared to COPDAC-28 plus standard involved node radiotherapy as in the C1 trial.
- Risk stratification is refined Former treatment groups (TG) of the EuroNet-PHL-C1 trial are reassigned into treatment levels (TL) by shifting early stage patients (former TG-1) with risk factors into TL-2.
- Semi-quantitative 'qPET' Results of semi-quantitative qPET are formally integrated into the response assessment.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||2200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||European Network-Paediatric Hodgkin Lymphoma Study Group (EuroNet-PHL) Second International Inter-Group Study for Classical Hodgkin Lymphoma in Children and Adolescents|
|Study Start Date :||October 2015|
|Estimated Primary Completion Date :||September 2021|
|Estimated Study Completion Date :||September 2021|
Active Comparator: COPDAC-28
cyclophosphamide, vincristine, prednisone, dacarbazine; cyclophosphamide 500 mg/m2, per infusion on day 1 + 8; vincristine 1.5 mg/m2 intravenously (capping dose 2 mg) on day 1 + 8 and prednisone 40 mg/m2/day by mouth divided into 3 doses (capping dose 80 mg/day) on day 1 - 15 and dacarbazine 250 mg/m2 infusion on day 1 - 3
Drug: cyclophosphamide, vincristine, prednisone, dacarbazine
28-day chemotherapy cycle
Other Name: CYC, VCR, PRED, DTIC
patients with intermediate and advanced stages will be randomized after the induction therapy to receive either COPDAC-28 standard consolidation or the intensified DECOPDAC-21. cyclophosphamide dose augmented to 625 mg/m2 and adminstered per infusion on day 1 and day 2; vincristine dose not changed; prednisone 40 mg/m2/day by mouth on day 1 - 8 (no capping dose prescribed), i.e. dose-reduction; dacarbazine dose not changed; etoposide infusion100 mg/m2/day on day 1 - 3 and doxorubicine 25 mg/m2 per infusion on day 1as additional drugs in comparison to active comparator; cycle is administered as 21 days instead of 28 days-cycle for intensification
Drug: cyclo, vcr, pred, dacarb,etop and doxo
21-day chemotherapy cycle
Other Name: CYC, VCR, PRED, DTIC, ETO, DOXO
- Event-free survival [ Time Frame: 5 years ]
- Overall survival [ Time Frame: 5 years ]
- Progression-free survival [ Time Frame: 5 years ]
- CTC (common toxicity criteria) grading during any individual treatment element including assessment of osteonecrosis [ Time Frame: 5 years ]Toxicity assessment according to CTCAE v4.0
- Time from day of PET imaging until decision on response category at ERA or LRA, respectively [ Time Frame: 5 years ]Quality of Imaging (CT,MRI and PET-CT) acquisition,
- Time from last day of chemotherapy to first day of radiotherapy in patients with radiotherapy indication [ Time Frame: 5 years ]Quality of chemo-and radiotherapy delivery
- Time from last dose of prednisone/prednisolone in OEPA to start of the first consolidation cycle [ Time Frame: 5 years ]Quality of chemotherapy delivery
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02684708
|Contact: Dieter Koerholz, MD||0049-641-985 ext email@example.com|
|Contact: Christine Mauz-Koerholz, MD||0049-641-985 ext firstname.lastname@example.org|
|Justus Liebig University of Giessen||Recruiting|
|Giessen, Germany, 35392|
|Contact: Dieter Koerholz, MD email@example.com|
|Contact: Christine Mauz-Koerholz, MD firstname.lastname@example.org|
|Study Chair:||Dieter Koerholz, MD||Justus-Liebig University of Giessen|