Post-operative Radiotherapy in Poor Responders Ewing's Sarcoma Patients
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|ClinicalTrials.gov Identifier: NCT01734863|
Recruitment Status : Withdrawn
First Posted : November 28, 2012
Last Update Posted : January 12, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Ewing's Sarcoma||Radiation: External Beam Radiotherapy||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Post-operative Radiotherapy Randomization in Poor Responders Ewing's Sarcoma Patients|
|Study Start Date :||September 2012|
|Estimated Primary Completion Date :||September 2022|
|Estimated Study Completion Date :||December 2022|
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:
- improved Local Relapse-free Survival (LRFS) [ Time Frame: five year event free survival ]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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01734863
|Children's Cancer Hospital Egypt 57357|
|Cairo, Egypt, 11441|
|Principal Investigator:||Mohamed s zaghloul, MD||Children's Cancer Hospital Egypt 57357|