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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2012 by Children's Cancer Hospital Egypt 57357
Sponsor:
Information provided by (Responsible Party):
Children's Cancer Hospital Egypt 57357
ClinicalTrials.gov Identifier:
NCT01734863
First received: November 19, 2012
Last updated: November 27, 2012
Last verified: November 2012

November 19, 2012
November 27, 2012
September 2012
September 2022   (final data collection date for primary outcome measure)
improved Local Relapse-free Survival (LRFS) [ Time Frame: five year event free survival ] [ Designated as safety issue: No ]
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).
Same as current
Complete list of historical versions of study NCT01734863 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Post-operative Radiotherapy in Poor Responders Ewing's Sarcoma Patients
Post-operative Radiotherapy Randomization in Poor Responders Ewing's Sarcoma Patients

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Ewing's Sarcoma
Radiation: External Beam Radiotherapy
  • 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:

      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.
    Intervention: Radiation: External Beam Radiotherapy
  • No Intervention: No Radiotherapy Arm

    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.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
150
December 2022
September 2022   (final data collection date for primary outcome measure)

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
Both
1 Year to 18 Years
No
Contact: Mohamed Zaghlol, MD (202)25351500 ext 1192 mszagh@yahoo.com
Contact: Ranin Magdi, Pharm B, CPHQ (202)25351500 raninmagdi@hotmail.com
Egypt
 
NCT01734863
CCHE-BoneT002
Yes
Children's Cancer Hospital Egypt 57357
Children's Cancer Hospital Egypt 57357
Not Provided
Principal Investigator: Mohamed s zaghloul, MD Children's Cancer Hospital Egypt 57357
Children's Cancer Hospital Egypt 57357
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP