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

NCT01734863 | Withdrawn Phase 3 DMC

• 1 other identifier: CCHE-BoneT002
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Ewing's Sarcoma

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Radiotherapy Arm

EXPERIMENTAL

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.

Radiation: External Beam Radiotherapy

No Radiotherapy Arm

NO INTERVENTION

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.

Interventions

External Beam Radiotherapy RADIATION

Radiotherapy Arm

Eligibility Criteria

• Age: 1 Year - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Children's Cancer Hospital Egypt 57357: lead

Study Sites (1)

Children's Cancer Hospital Egypt 57357

Cairo, 11441, Egypt

Location

MeSH Terms

Conditions

Sarcoma, Ewing

Condition Hierarchy (Ancestors)

Osteosarcoma; Neoplasms, Bone Tissue; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Sarcoma

Study Officials

• Mohamed s zaghloul, MD

  Children's Cancer Hospital Egypt 57357

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2012
• First Posted: November 28, 2012
• Study Start: September 1, 2012
• Primary Completion: September 1, 2022
• Study Completion: December 1, 2022
• Last Updated: January 12, 2016

Record last verified: 2012-11

Locations

EG (1)