Treatment of patients with Tumors of the Ewing Metastatic Family
Phase 3
Recruiting
- Conditions
- Ewing's sarcoma
- Registration Number
- RBR-8wd7tn
- Lead Sponsor
- Hospital de Clínicas de Porto Alegre
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- Not specified
Inclusion Criteria
Diagnosis of bone or soft tissue Ewing sarcoma; or extracellular PNET bone or soft tissue; who did not receive prior chemotherapy or radiation therapy;up to forty years; Informed Consent Form (TCLE) signed by the patient or his / her legal guardian;Number of participants in Brazil: 100
Exclusion Criteria
Unconfirmed diagnosis; Absence of metastases; Pregnancy and lactation; Patients with previous treatments for this disease; Patients participating in other studies using potentially therapeutic agents for this disease; Patients with metastatic Ewing's sarcoma as a second cancer, unless the first tumor was adequately treated squamous and basal cell skin carcinoma;
Study & Design
- Study Type
- Intervention
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Describe the event-free survival of the protocol that is defined as time from diagnosis to disease recurrence / progression. This is a study without a control group, which will recruit 200 patients over a five year period and there will be later comparison with historical controls<br>the survival will be studied through Kaplan-Meier curves,<br>being the effect of the various prognostic factors evaluated in a multivariate model<br>of proportional hazards regression (Cox model)<br>The data will be processed and analyzed with the aid of the SPSS program<br>(Statistical Package for the Social Sciences) and Epi Info<br>
- Secondary Outcome Measures
Name Time Method