Osteosarcoma
Conditions
Keywords
Non metastatic extremities high grade osteosarcoma
Brief summary
This is a phase II multicentre, uncontrolled trial including patients ≤ 40 years with non-metastatic extremity high-grade osteosarcoma stratified according to P-glicoprotein expression
Detailed description
The main objective of the study is to evaluate the impact on event-free survival (EFS) of a multi-drug chemotherapy approach and mifamurtide treatment in patients with non-metastatic osteosarcoma of the extremities according to the expression of ABCB1/P-glycoprotein
Interventions
DRUGMifamurtide arm
PRE SUGERY TREATMENT: Methotrexate: 12g/m2 (3 cycles) Cisplatinum: 120mg/m2 (3 cycles) Doxorubicin: ADM 75mg/m2 (3 cycles) POST SURGERY TREATMENT for good responder patients with positive P-GLYCOPROTEIN Methotrexate 12g/m2 (10 Cycles) Cisplatinum 120mg/m2; Doxorubicin 90mg/m2 MEPACT 2 mg/m2 twice a week for the first 3 months the weekly for the next 6 months (total lenght treatment 44 weeks) POST SURGERY TREATMENT for poor responder patients with positive P-GLYCOPROTEIN Methotrexate 12g/m2; Cisplatinum 120mg/m2; Doxorubicin 90mg/m2 ifosfamide 15g/m2 MEPACT 2 mg/m2 twice a week for the first 3 months the weekly for the next 6 months (total lenght treatment 44 weeks) All the product are used as commercial formulation
OTHER3 drugs arm
High grade osteosarcoma who do not over express ABCB1/P-glycoprotein will be treated with a standard 3-drugs regimen PRE-SUGERY TREATMENT: Methotrexate: 12g/m2 (3 cycles) Cisplatinum: 120mg/m2 (3 cycles) Doxorubicin: ADM 75mg/m2 (3 cycles) POST SURGERY TREATMENT: Methotrexate 12g/m2 (10 cycles) Cisplatinum 120mg/m2; Doxorubicin 90mg/m2 Total lenght 34 weeks All the product are used as commercial formulation
Sponsors
Italian Sarcoma Group
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 40 Years
Healthy volunteers
No
Inclusion criteria
* Histology confirmed diagnosis of extremities high grade osteosarcoma * Age ≤ 40 years * Localized disease or presence of skip metastasis * Hepatic, renal and bone marrow normal function * LVEF \> 50% * No previous surgery and/ or chemotheraputic osteosarcoma treatments, * No more than 4 weeks interval between histological diagnosis and start of chemotherapy * Informed consent to the study participation obtained.
Exclusion criteria
* Presence of metastases other than skip metastases * Periosteal Osteosarcoma, parostal osteosarcoma, secondary osteosarcoma, * Medical contra-indication to the drugs foreseen in the protocol, * Subject is pregnant or breast feeding * Mental or social conditions that can compromise a correct adherence to the protocol and its procedures
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Events free survival | After 5 years from the time to first day of chemotherapy for all patients and from the date of surgery for the Pgp overexpression patients stratified according to tumor necrosis (Good Responders and Poor Responders). | Onset of any event. An event is the defined as disease recurrence (local or distant), death for disease or any other cause, onset of secondary tumors or the last follow-up examination |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival | After 5 years from the time to first day of chemotherapy for all patients and from the date of surgery for the Pgp overexpression patients stratified according to tumor necrosis (Good Responders and Poor Responders). | Time elapsed for the diagnosis to the death for any cause or to the last follow-up examination. |
Countries
Italy
Outcome results
None listed