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

Ewing's Sarcoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01734863
• Other study ID #: CCHE-BoneT002
• Status: Withdrawn
• Phase: Phase 3
• First received: November 19, 2012
• Last updated: January 11, 2016
• Start date: September 2012
• Est. completion date: December 2022

Study information

• Verified date: November 2012
• Source: Children's Cancer Hospital Egypt 57357
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2022
• Est. primary completion date: September 2022
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Year to 18 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ewing's Sarcoma
• Sarcoma
• Sarcoma, Ewing

Intervention

Radiation:
• External Beam Radiotherapy

Locations

Country	Name	City	State
Egypt	Children's Cancer Hospital Egypt 57357	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Children's Cancer Hospital Egypt 57357

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No