Clinical trial · Interventional
Post-operative Radiotherapy in Poor Responders Ewing's Sarcoma Patients
Post-operative Radiotherapy Randomization in Poor Responders Ewing's Sarcoma Patients
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ewing's Sarcoma | Ewing Sarcoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| External Beam Radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Radiotherapy Arm
- description
- 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: 1. Age \< 18 years old. 2. Non-metastatic Ewing Sarcoma patients who will undergo surgery and show poor histologic response to neo-adjuvant chemotherapy. 3. Negative surgical margins. 4. Patients show good safety profile and acceptable performance status.
- interventionNames
- Radiation: External Beam Radiotherapy
- type
- NO_INTERVENTION
- label
- No Radiotherapy Arm
- description
- this arm will not take radiotherapy and their inclusion criteria as following: 1. Age \< 18 years old. 2. Non-metastatic Ewing Sarcoma patients who will undergo surgery and show poor histologic response to neo-adjuvant chemotherapy. 3. Negative surgical margins. 4. Patients show good safety profile and acceptable performance status.
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 1 Year
- Maximum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available