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

Sponsor

Children's Cancer Hospital Egypt 57357 (Other)

Overall Status

Withdrawn

CT.gov ID

NCT01734863

Collaborator

(none)

Enrollment

Location

Arms

123

Duration (Months)

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Ewing's Sarcoma	Radiation: External Beam Radiotherapy	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Sep 1, 2012

Anticipated Primary Completion Date :

Sep 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Radiotherapy Arm 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.	Radiation: External Beam Radiotherapy
No Intervention: No Radiotherapy Arm 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.

Arm

Intervention/Treatment

Experimental: Radiotherapy Arm

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.

Radiation: External Beam Radiotherapy

No Intervention: No Radiotherapy Arm

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.

Outcome Measures

Primary Outcome Measures

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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Year to 18 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Children's Cancer Hospital Egypt 57357	Cairo		Egypt	11441

Sponsors and Collaborators

Children's Cancer Hospital Egypt 57357

Investigators

Principal Investigator: Mohamed s zaghloul, MD, Children's Cancer Hospital Egypt 57357

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Children's Cancer Hospital Egypt 57357

ClinicalTrials.gov Identifier:

NCT01734863

Other Study ID Numbers:

CCHE-BoneT002

First Posted:

Nov 28, 2012

Last Update Posted:

Jan 12, 2016

Last Verified:

Nov 1, 2012

Additional relevant MeSH terms:

Sarcoma

Sarcoma, Ewing

Study Results

No Results Posted as of Jan 12, 2016