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Treatment for Classical Hodgkin Lymphoma in Children and Adolescents
Sponsor: GALIA AVRAHAMI
Summary
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.
Official title: 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)
Key Details
Gender
All
Age Range
1 Month - 18 Years
Study Type
INTERVENTIONAL
Enrollment
2200
Start Date
2015-11
Completion Date
2027-12
Last Updated
2016-06-14
Healthy Volunteers
No
Interventions
Radiotherapy:
All patients will have 2 "OPEA"cycles(chemotherapy cycle:Vincristine,Etoposide,Prednisone,doxorubicin) ,After assignment ( by randomization) to one of the arms the patient will be treated accordingly . response assessment will be done after "OPEA" cycles (ERA) and after cycles of "copdac 28" or DECOPDAC 21(LRA).according to the assessments results patients will have radiotherapy or not.
Vincristine
ARM A and ARM B
Etoposide
ARM B , 100mg/m2/day
Prednisone
ARM A and ARM B , 40mg/m2/day p.o
Doxorubicin
ARM B , 25mg/m2
Dacarbazine
ARM A and ARM B , 250mg/m2 i.v
Cyclophosphamide
ARM A and ARM B , 625mg/m2 i.v
Locations (1)
Schneider children's medical center
Petah Tikva, Israel