Efficacy of Dose Intensification in Patients With Non-metastatic Ewing Sarcoma (EW-1)
Ewing's Sarcoma
About this trial
This is an interventional treatment trial for Ewing's Sarcoma focused on measuring Non metastatic Ewing's Sarcoma
Eligibility Criteria
Inclusion Criteria
- Ewing Sarcoma or PNET diagnosis centrally confirmed
- Age ≤ 40 years
- Absence of evident metastasis or lung met < 0.5 cm Presence of skip metastasis in the bone compartment of the primary tumor is to be considered as local disease and not metastatic.
- Adeguate bone marrow, hepatic and renal function
- Left Ventricular Ejection Fraction > 50%
- No primary Ewing Sarcoma treatments (both chemotherapy and/or radiotherapy)
- Voluntarily signed an informed consent form
- Radiological and histological documentation available for central review.
Exclusion Criteria
- Presence of lung or extra-pulmonary lesions
- Bone Marrow involvement
- In case of chest disease: presence of plural effusion
- Elapsed time between histological diagnosis and chemotherapy start, more than 4 weeks
- Any medical contraindication to the use of the study drugs
- Any psychological or social conditions that can compromise the protocol compliance and/or follow-up
- Previous malignancies (excluded in situ cervix carcinoma)
Sites / Locations
- Centro di Riferimento Oncologico - Unit of Medical Oncology
- I.R.C.C. - Unit of Medical Oncology
- IRCCS materno infantile Burlo Garofolo
- Azienda Ospedaliero Universitaria Consorziale Policlinico - Bari
- Istituto Ortopedico Rizzoli
- A.O. Universitaria Meyer
- Istituto Giannina Gaslini
- FONDAZIONE IRCCS Istituto Nazionale dei Tumori
- Azienda Ospedaliera Universitaria "Federico Ii" .
- Azienda Ospedaliera di Padova
- Azienda Ospedaliero Universitaria Pisana
- Istituto Nazionale Tumori Regina Elena - Unit of Medical Oncology I
- Ospedale Pediatrico Bambin Gesu'
- Ospedale Infantile Regina Margherita - Unit of Paediatric Oncoematology
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
Standard treatment (as per ISG SSG III protocol)
Intensified treatment
Standard treatment for non metastatic Ewing's Sarcoma (as defined by the ISG/SSG III protocol). It is based on a 6 drugs pre-local treatment (Vincristin, dactinomycin, cyclophosphamide,ifosfamide,etoposide and doxorubicin) followed by local treatment (surgery and/or radiotherapy)and by a maintenance treatment based on induction response
Dose intense treatment for non metastatic Ewing's Sarcoma It is based on a 3 drug pre-local treatment (Vincristin, ifosfamide and doxorubicin)followed by local treatment (surgery and/or radiotherapy)and by a maintenance treatment based on induction response