Post-operative Radiotherapy in Poor Responders Ewing's Sarcoma Patients
Local recurrence after surgical resection is a complex phenomenon. An important predictive factor is the response to chemotherapy. Central site of disease may be a second independent predictive factor (Lin et al. 2007). Patients with more than 10% viable tumour cells at surgery following neo-adjuvant chemotherapy had a less favourable outcome with an Event-free Survival [EFS] of 47% after 10 years. Patients with good histological response (< 10% viable tumour cells) after chemotherapy alone had a prognosis of about 70% after 10 years.
However, further studies are necessary to determine the merit of adjuvant radiation for high-risk patients (poor responders). Taking into consideration that the toxicity and morbidity of combined surgery and radiation is greater than either alone and must be closely monitored.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Post-operative Radiotherapy Randomization in Poor Responders Ewing's Sarcoma Patients|
- improved Local Relapse-free Survival (LRFS) [ Time Frame: five year event free survival ] [ Designated as safety issue: No ]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).
|Study Start Date:||September 2012|
|Estimated Study Completion Date:||December 2022|
|Estimated Primary Completion Date:||September 2022 (Final data collection date for primary outcome measure)|
Experimental: Radiotherapy Arm
this study arm will take External Beam radiotherapy as follows :
|Radiation: External Beam Radiotherapy|
No Intervention: No Radiotherapy Arm
this arm will not take radiotherapy and their inclusion criteria as following:
Please refer to this study by its ClinicalTrials.gov identifier: NCT01734863
|Children's Cancer Hospital Egypt 57357|
|Cairo, Egypt, 11441|
|Principal Investigator:||Mohamed s zaghloul, MD||Children's Cancer Hospital Egypt 57357|