Text Size

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

This study is currently recruiting participants.
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
History of Changes
  Purpose

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 Intervention Phase
Ewing's Sarcoma
 Radiation: External Beam Radiotherapy
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Post-operative Radiotherapy Randomization in Poor Responders Ewing's Sarcoma Patients

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Children's Cancer Hospital Egypt 57357:

Primary Outcome Measures:
  • 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).


Estimated Enrollment: 150
Study Start Date: September 2012
Estimated Study Completion Date: December 2022
Estimated Primary Completion Date: September 2022 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
 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.

  Eligibility

Ages Eligible for Study:   1 Year to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01734863

Contacts
Contact: Mohamed Zaghlol, MD (202)25351500 ext 1192 mszagh@yahoo.com
Contact: Ranin Magdi, Pharm B, CPHQ (202)25351500 raninmagdi@hotmail.com

Locations
Egypt
Children's Cancer Hospital Egypt 57357 Recruiting
Cairo, Egypt, 11441
Contact: Mohamed S Zaghloul, MD     202-25351500 ext 1192     mszagh@yahoo.com    
Contact: Ranin Magdi, Pharm B, CPHQ     202-25351500     raninmagdi@hotmail.com    
Principal Investigator: Mohamed s Zaghloul, MD            
Sponsors and Collaborators
Children's Cancer Hospital Egypt 57357
Investigators
Principal Investigator: Mohamed s zaghloul, MD Children's Cancer Hospital Egypt 57357
  More Information

No publications provided

Responsible Party: Children's Cancer Hospital Egypt 57357
ClinicalTrials.gov Identifier: NCT01734863     History of Changes
Other Study ID Numbers: CCHE-BoneT002
Study First Received: November 19, 2012
Last Updated: November 27, 2012
Health Authority: Egypt: Institutional Review Board

Additional relevant MeSH terms:
Sarcoma, Ewing's
Neuroectodermal Tumors, Primitive, Peripheral
Sarcoma
Osteosarcoma
Neoplasms, Bone Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
 Neoplasms
Neuroectodermal Tumors, Primitive
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue

ClinicalTrials.gov processed this record on May 16, 2013