Trial Information
Post-operative Radiotherapy Randomization in Poor Responders Ewing's Sarcoma Patients
Inclusion Criteria:
- Age < 18 years old.
- Non-metastatic Ewing Sarcoma patients who will undergo surgery and show poor
histologic response to neo-adjuvant chemotherapy.
- Negative surgical margins.
- Patients show good safety profile and acceptable performance status.
Exclusion Criteria:
- Patients who show progressive disease and undergo surgery before the time of local
control.
- Patients who undergo Amputation or Rotationplasty will be excluded.
- Post-surgical complications that may hinder the administration of radiotherapy
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
improved Local Relapse-free Survival (LRFS)
Outcome Description:
Determine whether the administration of post-operative radiotherapy for poor responder Ewing Sarcoma patients to neo-adjuvant chemotherapy and radical surgery, leads to improved Local Relapse-free Survival (LRFS).
Outcome Time Frame:
five year event free survival
Safety Issue:
No
Principal Investigator
Mohamed s zaghloul, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Children's Cancer Hospital Egypt 57357
Authority:
Egypt: Institutional Review Board
Study ID:
CCHE-BoneT002
NCT ID:
NCT01734863
Start Date:
September 2012
Completion Date:
December 2022
Related Keywords:
- Ewing's Sarcoma
- Sarcoma, Ewing's
- Neuroectodermal Tumors, Primitive, Peripheral
- Sarcoma