Phase II randomized study for the comparison of the Gemcitabine plus Docetaxel and the Ifosfamide treatment of patients with relapsed osteosarcoma
Patients with relapsed osteosarcoma will be randomized to receive Gemcitabine plus Docetaxel or High Doses Ifosfamide (continuous infusion) every 3 weeks, up to 6 weeks
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
7
Treatment with gemcitabine and docetaxel at day 1 and day 8 n a 3 weeks cycle
Treatment arm with high doses of ifosfamide continous infusion for 14 days in a 3 weeks cycle
Fondazione del Piemonte per l'Oncologia IRCC Candiolo
Candiolo, Torino, Italy
Ospedale Gradenigo
Torino, TO, Italy
Istituti Ortopedici Rizzoli - Unit of Chemotherapy of Muscoloskeletal Tumors
Bologna, Italy
Progression Free Survival
Survival without progression of disease assessed at 6 months from randomization
Time frame: at 6 months from randomization
Overall Response Rate
Rate of tumor response assessed after cycle 2, 4 and 6
Time frame: After 6, 12 and 18 weeks
Overall Survival
From date of starting therapy until the date of death from any cause, whichever came first, assessed up to 60 months
Time frame: At patient death or at last available follow-up
Post treatment Surgery Rate
Rate of patients who will require surgery after 2, 4 and 6 study treatment cycles
Time frame: After 6, 12 and 18 weeks
Adverse Events Incidence
Number and grade of adverse events related to the study treatments
Time frame: Every 3 weeks up to 22 weeks
Quality of life assesment: data will be collected by using specific oncologic Quality of Life instruments
Quality of Life evaluation related to received chemotherapy
Time frame: After 6, 12 and 18 weeks and at 12 Months after end of treatment
Duration of hospitalization
Number of days spent in hospital related to treatment received
Time frame: After 1,3, 4, 6, 7, 9, 10, 12, 13, 15, 16 and 18 weeks
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A.O. Universitaria Meyer
Florence, Italy
Istituto Giannina Gaslini
Genova, Italy
FONDAZIONE IRCCS Istituto Nazionale dei Tumori
Milan, Italy
Università seconda di Napoli
Napoli, Italy
Azienda Ospedaliera di Padova
Padua, Italy
Istituto Regina Elena - IFO
Rome, Italy
Ospedale Infantile Regina Margherita - Unit of Paediatric Oncoematology
Torino, Italy