search
Back to results

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

Primary Purpose

Ewing's Sarcoma

Status
Withdrawn
Phase
Phase 3
Locations
Egypt
Study Type
Interventional
Intervention
External Beam Radiotherapy
Sponsored by
Children's Cancer Hospital Egypt 57357
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ewing's Sarcoma

Eligibility Criteria

1 Year - 18 Years (Child, Adult)All SexesDoes not accept 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

Sites / Locations

  • Children's Cancer Hospital Egypt 57357

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Radiotherapy Arm

No Radiotherapy Arm

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: 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.

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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Full Information

First Posted
November 19, 2012
Last Updated
January 11, 2016
Sponsor
Children's Cancer Hospital Egypt 57357
search

1. Study Identification

Unique Protocol Identification Number
NCT01734863
Brief Title
Post-operative Radiotherapy in Poor Responders Ewing's Sarcoma Patients
Official Title
Post-operative Radiotherapy Randomization in Poor Responders Ewing's Sarcoma Patients
Study Type
Interventional

2. Study Status

Record Verification Date
November 2012
Overall Recruitment Status
Withdrawn
Study Start Date
September 2012 (undefined)
Primary Completion Date
September 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Cancer Hospital Egypt 57357

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ewing's Sarcoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Radiotherapy Arm
Arm Type
Experimental
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: 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.
Arm Title
No Radiotherapy Arm
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Radiation
Intervention Name(s)
External Beam Radiotherapy
Primary Outcome Measure Information:
Title
improved Local Relapse-free Survival (LRFS)
Description
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).
Time Frame
five year event free survival

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohamed s zaghloul, MD
Organizational Affiliation
Children's Cancer Hospital Egypt 57357
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Cancer Hospital Egypt 57357
City
Cairo
ZIP/Postal Code
11441
Country
Egypt

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs