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


Phase 3
1 Year
18 Years
Open (Enrolling)
Both
Ewing's Sarcoma

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

improved Local Relapse-free Survival (LRFS)

Outcome 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).

Outcome Time Frame:

five year event free survival

Safety Issue:

No

Principal Investigator

Mohamed s zaghloul, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Children's Cancer Hospital Egypt 57357

Authority:

Egypt: Institutional Review Board

Study ID:

CCHE-BoneT002

NCT ID:

NCT01734863

Start Date:

September 2012

Completion Date:

December 2022

Related Keywords:

  • Ewing's Sarcoma
  • Sarcoma, Ewing's
  • Neuroectodermal Tumors, Primitive, Peripheral
  • Sarcoma

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