Spots Global Cancer Trial Database for Efficacy of Dose Intensification in Patients With Non-metastatic Ewing Sarcoma
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Trial Identification
Brief Title: Efficacy of Dose Intensification in Patients With Non-metastatic Ewing Sarcoma
Official Title: Phase III Study on Efficacy of Dose Intensification in Patients With Non-metastatic Ewing Sarcoma.
Study ID: NCT02063022
Conditions
Study Description
Brief Summary: Controlled, randomized phase III study, with the intent of optimizing the treatment of not metastatic Ewing Sarcoma. The patients will be randomized into 2 arms: standard treatment vs intensive treatment. Both arms will receive an induction treatment followed by surgery (wherever is possible) and/or radiotherapy. The maintenance treatment will be different on the basis of the response to the induction treatment (good or poor)
Detailed Description: Eligible patients with non metastatic Ewing's Sarcoma will be randomized into 2 different arms: standard treatment arm A (based on the ISG/SSG III protocol) or into the experimental arm B(chemotherapy with dose intensification and shorter length of treatment). Both arm will receive an induction treatment with higher dose intensity of doxorubicin and ifosfamide in Arm B. After the induction treatment all the patient will undergo to local treatment (surgery and/or radiotherapy)that will be followed by a maintenance therapy. The maintenance therapy will be different for both arms and, within each arm, on the basis of the response (histologically evaluated) of the pre-local treatment therapy. Maintenance for Arm A: Poor responders will undergo to stem cells apheresis and their reinfusion after treatment with high doses of Busulfan and Melphalan 25 weeks. Good responders will receive a 6 drugs maintenance treatment for 37 weeks (as per standard ISG/SSG III protocol) Maintenance for Arm B: Poor responders will undergo to stem cells apheresis and their reinfusion after an intensified treatment with high doses of Busulfan and Melphalan (25 weeks). Good responders will receive a maintenance treatment for 25 weeks The primary aim of the study is to assess the Event Free Survival (EFS) that is expected to be similar in both arms The secondary objectives are: To assess if the induction treatment in Arm B is able to increase the percentage of good responders compared to those who receive standard treatment. To assess the toxicity and the Quality of Life related to the chemotherapy treatment
Keywords
Eligibility
Minimum Age:
Eligible Ages: CHILD, ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Centro di Riferimento Oncologico - Unit of Medical Oncology, Aviano, Pordenone, Italy
I.R.C.C. - Unit of Medical Oncology, Candiolo, Torino, Italy
IRCCS materno infantile Burlo Garofolo, Trieste, T, Italy
Azienda Ospedaliero Universitaria Consorziale Policlinico - Bari, Bari, , Italy
Istituto Ortopedico Rizzoli, Bologna, , Italy
A.O. Universitaria Meyer, Firenze, , Italy
Istituto Giannina Gaslini, Genova, , Italy
FONDAZIONE IRCCS Istituto Nazionale dei Tumori, Milano, , Italy
Azienda Ospedaliera Universitaria "Federico Ii" ., Napoli, , Italy
Azienda Ospedaliera di Padova, Padova, , Italy
Azienda Ospedaliero Universitaria Pisana, Pisa, , Italy
Istituto Nazionale Tumori Regina Elena - Unit of Medical Oncology I, Roma, , Italy
Ospedale Pediatrico Bambin Gesu', Roma, , Italy
Ospedale Infantile Regina Margherita - Unit of Paediatric Oncoematology, Torino, , Italy
Contact Details
Name: Roberto Luksch, MD
Affiliation: Italian Sarcoma Group
Role: PRINCIPAL_INVESTIGATOR
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