Sulamerican syudy for the treatment of patients with non-metastatic ewing family tumors
- Conditions
- Ewing's sarcoma
- Registration Number
- RBR-6qpzjq
- Lead Sponsor
- Instituto do Câncer Infantil
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- Not specified
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;
Pregnant or lactating; Metastases; Patients receiving previous QT, RT or QT and RT treatments for this disease; History of another malignant disease, other than adequately treated squamous or basal cell carcinoma of the skin; Unstable heart disease despite treatment;
History of significant neurological or psychiatric disorders Uncontrolled active infection Uncontrolled diabetes mellitus Known hypersensitivity to components of the medications used in the study Patients who are participating in any other clinical study with a potentially therapeutical agent;
Study & Design
- Study Type
- Intervention
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To evaluate, in a randomized trial, the addition of metronomic (maintenance) treatment with intravenous vimblastine and oral cyclophosphamide after the end of conventional treatment improves event-free survival for patients with localized FET<br>randomized to receive metronomic treatment will benefit from a 15% increase in SLE over 5 years compared to patients who will not receive metronomic treatment<br>It will require at least 130 patients in each of the two regimens to identify any significant difference (power of 80 % e ? = 0.05)
- Secondary Outcome Measures
Name Time Method Overall survival<br>It will be calculated from the time of diagnosis of the disease and the event of death of the patient. Patients with loss of follow up will be censored on the date of the last visit. Descriptive analyzes will be presented.;Incidence of general protocol toxicity;<br>Toxicity will be calculated according to the Common Terminology Criteria for Adverse Events v3.0 (CTCAE).;Incidence of secondary tumors;<br>The numerical descriptive percentage of secondary tumors during the study will be evaluated.