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

Study Overview
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Brief Summary
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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.

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

Conditions
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Ewing's Sarcoma

Intervention / Treatment
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* Radiation: External Beam Radiotherapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Radiotherapy Arm<br>this study arm will take External Beam radiotherapy as follows : Radiotherapy Technique: Conformal radiotherapy, Intensity modulated radiotherapy [IMRT] is allowed. Radiotherapy Dose: 45 Gy/25 fractions/5 weeks (1.8 Gy/fraction). , the inclusion criteria are as following: 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. | Radiation: External Beam Radiotherapy<br> <br> |
| No Intervention: No Radiotherapy Arm<br>this arm will not take radiotherapy and their inclusion criteria as following: 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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| improved Local Relapse-free Survival (LRFS) | 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). | five year event free survival |