Clinical Trial: Post-operative Radiotherapy in Poor Responders Ewing's Sarcoma Patients

Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional

Official Title: Post-operative Radiotherapy Randomization in Poor Responders Ewing's Sarcoma Patients

Brief Summary:

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.


Detailed Summary:
Sponsor: Children's Cancer Hospital Egypt 57357

Current Primary Outcome: 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).


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Children's Cancer Hospital Egypt 57357

Dates:
Date Received: November 19, 2012
Date Started: September 2012
Date Completion: December 2022
Last Updated: January 11, 2016
Last Verified: November 2012