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

NCT01734863 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2016-01-12

No results posted yet for this study

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.

Conditions

  • Ewing's Sarcoma

Interventions

RADIATION

External Beam Radiotherapy

Sponsors & Collaborators

  • Children's Cancer Hospital Egypt 57357

    lead OTHER

Principal Investigators

  • Mohamed s zaghloul, MD · Children's Cancer Hospital Egypt 57357

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-09-30
Primary Completion
2022-09-30
Completion
2022-12-31

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01734863 on ClinicalTrials.gov