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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
2,200
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.
ARM A and ARM B
ARM B , 100mg/m2/day
Schneider children's medical center
Petah Tikva, Israel
RECRUITINGIncrease event free survival rate from 88% to 93%
Methods of measurement: chest X-ray; US neck, abdomen and pelvis; lung function; T4,Throid Stimulating Hormone ,US of thyroid; MRI of initially involved region; chest CT in patients with initial lung involvement.
Time frame: Will be assessed once a year up to 5 years after end of treatment.
comparison of haematotoxicity between arm A and arm B
Evaluation of haematotoxicity by documentation of blood count courses during "OEPA", COPDAC-28 and DECOPDAC-21 cycles. Comparison between COPDAC-28 versus DECOPDAC-21. For ERA(early response assessment) PET(Positron Emission Tomography)-positive patients to compare to the LRA (late response assessment)PET-positivity rates after consolidation chemotherapy with COPDAC-28 or DECOPDAC-21.
Time frame: Will be assessed in day 0,day 8,day 11,day 17 and day 21 of each cycle
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ARM A and ARM B , 40mg/m2/day p.o
ARM B , 25mg/m2
ARM A and ARM B , 250mg/m2 i.v
ARM A and ARM B , 625mg/m2 i.v