Status:
COMPLETED
ABCB1/P-glycoprotein Expression as Biologic Stratification Factor for Patients With Non Metastatic Osteosarcoma
Lead Sponsor:
Italian Sarcoma Group
Conditions:
Osteosarcoma
Eligibility:
All Genders
Up to 40 years
Phase:
PHASE2
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 t...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 23 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 30 2024
Estimated Enrollment :
225 Patients enrolled
Trial Details
Trial ID
NCT01459484
Start Date
June 23 2011
End Date
April 30 2024
Last Update
May 20 2024
Active Locations (11)
Enter a location and click search to find clinical trials sorted by distance.
1
I.R.C.C. - Unit of Medical Oncology
Candiolo, Torino, Italy, 10060
2
Presidio Sanitario Gradenigo
Torino, TO, Italy, 10153
3
IRCCS Istituto ortopedico Rizzoli
Bologna, Italy, 40136
4
A.O. Universitaria Meyer
Florence, Italy, 50139