Post-operative Radiotherapy in Poor Responders Ewing's Sarcoma Patients
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| First Received Date ICMJE | November 19, 2012 | ||||||||
| Last Updated Date | November 27, 2012 | ||||||||
| Start Date ICMJE | September 2012 | ||||||||
| Estimated Primary Completion Date | September 2022 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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). |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01734863 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Post-operative Radiotherapy in Poor Responders Ewing's Sarcoma Patients | ||||||||
| Official Title ICMJE | Post-operative Radiotherapy Randomization in Poor Responders Ewing's Sarcoma Patients | ||||||||
| Brief 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. |
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| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Phase 3 | ||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Ewing's Sarcoma | ||||||||
| Intervention ICMJE | Radiation: External Beam Radiotherapy | ||||||||
| Study Arm (s) |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 150 | ||||||||
| Estimated Completion Date | December 2022 | ||||||||
| Estimated Primary Completion Date | September 2022 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 1 Year to 18 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | Egypt | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01734863 | ||||||||
| Other Study ID Numbers ICMJE | CCHE-BoneT002 | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | Children's Cancer Hospital Egypt 57357 | ||||||||
| Study Sponsor ICMJE | Children's Cancer Hospital Egypt 57357 | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | Children's Cancer Hospital Egypt 57357 | ||||||||
| Verification Date | November 2012 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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