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

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

Status

Withdrawn

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01734863

Enrollment

Registered

2012-11-28

Start date

2012-09-30

Completion date

2022-12-31

Last updated

2016-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ewing's Sarcoma

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.

Interventions

RADIATIONExternal Beam Radiotherapy

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

1 Years to 18 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
improved Local Relapse-free Survival (LRFS)	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).

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026