Ewing's sarcoma
Conditions
Interventions
400 non-metastatic patients diagnosed with Ewing's sarcoma will receive alternating cycles of VDC (Vincristine, Doxorubicin and Cyclophosphamide) and IE (Ifosfamide and Etoposide) - completing 14 cycl
we consider it important that in these patients, surgery be done as soon as possible after radiotherapy (it is not prudent to delay surgery) Patients with dry pelvic tumors resected with free margins
Q65.070
Sponsors
Instituto do Câncer Infantil
Instituto do Câncer Infantil
Rafael Koff Acordi
Eligibility
Age
No minimum to 40 Years
Inclusion criteria
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;
Exclusion criteria
Exclusion criteria: 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;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 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 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
| Measure | Time frame |
|---|---|
| Overall survival 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; Toxicity will be calculated according to the Common Terminology Criteria for Adverse Events v3.0 (CTCAE).;Incidence of secondary tumors; The numerical descriptive percentage of secondary tumors during the study will be evaluated. | — |
Countries
Argentina, Brazil, Chile, Uruguay
Contacts
Public ContactJulie;Lauro Cerutti;Gregianin
Instituto do Câncer Infantil;Hospital de Clínicas de Porto Alegre
Outcome results
None listed