Clinical trial · Interventional
Treatment for Classical Hodgkin Lymphoma in Children and Adolescents
An International, Multicentre, Randomised Controlled Trial. Treatment for Classical Hodgkin Lymphoma in Children and Adolescents Standard Treatment (Chemotherapy and RT) Compared With Experimental Treatment (Chemotherapy Without RT or Restricted to RT)
NCT02797717CI-TRIAL-00022580EuroNet-PHL-C2recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Reduction of the indication for radiotherapy (RT) in newly diagnosed patients with classical Hodgkins lymphoma without compromising cure rates. Investigation of a chemotherapy intensification randomisation in intermediate and advanced classical Hodgkins lymphoma patients to compensate for reduction in RT.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Classical Hodgkins Lymphoma in Children and Adolescents. | — | UNRESOLVED | — |
Interventions
Interventions (7)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| Dacarbazine | Drug | Dacarbazine | ALIAS |
| Doxorubicin | Drug | Doxorubicin | ALIAS |
| Etoposide | Drug | Etoposide | ALIAS |
| Prednisone | Drug | Prednisone | ALIAS |
| Radiotherapy: | Radiation | — | UNRESOLVED |
| Vincristine | Drug | Vincristine | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- A-"COPDAC-28"
- description
- standard COPDAC-28 (chemotherapy cycle:Cyclophosphamide,Doxorubicin,Prednisone,Dacarbazine), chemotherapy and standard involved node radiotherapy. drugs: Prednisone 40mg/m2/day,P.O,day 1-day 15. Dacarbazine 250mg/m2, I.V. , infusion,day 1- day 3. Vincristine 15mg/m2 , I.V. , day1+day 8. Cyclophosphamide 500mg/m2,infusion,day 1+day 8.
- interventionNames
- Radiation: Radiotherapy:
- Drug: Vincristine
- Drug: Prednisone
- Drug: Dacarbazine
- Drug: Cyclophosphamide
- type
- EXPERIMENTAL
- label
- B- "DECOPDAC-21"
- description
- DECOPDAC-21(chemotherapy cycle:Dacarbazine,Etoposide,Doxorubicin,Cyclophosphamide,Prednisone,Vincristine) intensified chemotherapy and no RT or restricted fields of radiotherapy. Drugs: Prednisone 40mg/m2/day,P.O,day 1-day 15: Dacarbazine 250mg/m2, I.V. , infusion,day 1- day 3 Vincristine 15mg/m2 , I.V. , day1+day 8 Cyclophosphamide 625mg/m2,infusion,day1+day2 Etoposide 100mg/m2/day,infusion,day 1- day 3 Doxorubicin 25mg/m2, infusion, day 1
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 1 Month
- Maximum age
- 18 Years
Show eligibility criteria text
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 specialized Teenage and Young Adult (TYA) units in Australia, France, Italy, New Zealand and United Kingdom patients up to 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 Exclusion Criteria: (Patients with one or more of the following criterion are excluded) 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
References
Publications (0)
Data not yet available
No reference posted for this study.