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ASSG Endorsed Clinical Study

ASSG21-EEO8

Title EWING 2008
Objective The primary objective is to assess whether either of the randomised treatments is superior regarding 3-year event-free survival.
Type Randomised, prospective, multi-centre, international study
Population Male and female patients 4-50 yrs with histologically confirmed Ewing sarcoma of bone or soft tissue.
Treatment "All patients registered will receive induction chemotherapy consisting of six cycles of vincristine, ifosfamide, doxorubicin and etoposide (VIDE). The decision regarding local therapy must be made following the fifth cycle of induction treatment, with a preference for surgical intervention with or without additional radiotherapy.
Patients are then randomised to one of three groups:
R1: further eight cycles of chemotherapy composed of vincristine, actinomycin D, and cyclophosphamide (VAC) (females) or ifosfamide instead of cyclophosphamide (VAI) (males). They will be randomised to receive add-on treatment with zoledronic acid or no add-on treatment.
R2: Patients will receive either eight cycles of VAI chemotherapy or one cycle of VAI followed by high-dose treatment with busulfan-melphalan (R2loc).
Patients with primary pulmonary metastases will receive either eight cycles of VAI chemotherapy or one cycle of VAI followed by high-dose treatment with busulfan-melphalan (R2pulm).
R3: Patients are then randomised to either continue with eight cycles of vincristine, actinomycin D and cyclophosphamide (VAC) chemotherapy or high-dose treosulfan-melphalan (TreoMel) chemotherapy followed by autologous stem cell reinfusion followed thereafter by eight cycles of VAC chemotherapy."
Phase Ph III
Drug / Intervention "All patients registered will receive induction chemotherapy consisting of six cycles of vincristine, ifosfamide, doxorubicin and etoposide (VIDE). The decision regarding local therapy must be made following the fifth cycle of induction treatment, with a preference for surgical intervention with or without additional radiotherapy.
Patients are then randomised to one of three groups:
R1: further eight cycles of chemotherapy composed of vincristine, actinomycin D, and cyclophosphamide (VAC) (females) or ifosfamide instead of cyclophosphamide (VAI) (males). They will be randomised to receive add-on treatment with zoledronic acid or no add-on treatment.
R2: Patients will receive either eight cycles of VAI chemotherapy or one cycle of VAI followed by high-dose treatment with busulfan-melphalan (R2loc).
Patients with primary pulmonary metastases will receive either eight cycles of VAI chemotherapy or one cycle of VAI followed by high-dose treatment with busulfan-melphalan (R2pulm).
R3: Patients are then randomised to either continue with eight cycles of vincristine, actinomycin D and cyclophosphamide (VAC) chemotherapy or high-dose treosulfan-melphalan (TreoMel) chemotherapy followed by autologous stem cell reinfusion followed thereafter by eight cycles of VAC chemotherapy."
Sponsor EuroEwings
Funding Source (AUS): Rainbows for Kate, ASSG
Target accrual AUS: 50
Expected Completion 31/12/29
Participating Sites Monash, Peter MacCallum Cancer Centre, Princess Margaret, Royal Children's-Melbourne
Recruitment Status Open to accrual
Numbers Accrued 9
Publications and Presentations None as reported
 
Principal Investigator Dr Vivek Bhadri
Contact for Further Information Dr Vivek Bhadri
Contact Phone Number Dr Vivek Bhadri (02-85140749)
vivek.bhadri@lh.org.au
Last update 01-Aug-2017 03:00 PM 

 

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