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

Children's Cancer Hospital Egypt 57357

Status and phase: Withdrawn; Phase 3

Conditions: Ewing's Sarcoma

Treatments: Radiation: External Beam Radiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT01734863

CCHE-BoneT002

Details and patient eligibility

About

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.

Sex: All

Ages: 1 to 18 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Radiotherapy Arm

Experimental group

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: 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.

Treatment:

Radiation: External Beam Radiotherapy

No Radiotherapy Arm

No Intervention group

Description:

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.