Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT02797717
NA

Treatment for Classical Hodgkin Lymphoma in Children and Adolescents

Sponsor: GALIA AVRAHAMI

View on ClinicalTrials.gov

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

RADIATION

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.

DRUG

Vincristine

ARM A and ARM B

DRUG

Etoposide

ARM B , 100mg/m2/day

DRUG

Prednisone

ARM A and ARM B , 40mg/m2/day p.o

DRUG

Doxorubicin

ARM B , 25mg/m2

DRUG

Dacarbazine

ARM A and ARM B , 250mg/m2 i.v

DRUG

Cyclophosphamide

ARM A and ARM B , 625mg/m2 i.v

Locations (1)

Schneider children's medical center

Petah Tikva, Israel