ABCB1/P-glycoprotein Expression as Biologic Stratification Factor for Patients With Non Metastatic Osteosarcoma

• Register: ClinicalTrials.gov
• Last refreshed on: 16 October 2023
• Main ID: NCT01459484
• Date of registration: 19/10/2011
• Prospective Registration: No
• Primary sponsor: Italian Sarcoma Group
• Public title: ABCB1/P-glycoprotein Expression as Biologic Stratification Factor for Patients With Non Metastatic Osteosarcoma ISG/OS-2
• Scientific title: ABCB1/P-glycoprotein Expression as Biologic Stratification Factor for Patients With Non Metastatic Osteosarcoma - Prospective Study (ISG/OS-2)
• Date of first enrolment: June 23, 2011
• Target sample size: 225
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/ct2/show/NCT01459484
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

Italy

Contacts

• Name: Emanuela Palmerini, MD
• Affiliation: Istituto Ortopedico Rizzoli

Key inclusion & exclusion criteria

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



Age minimum: N/A
Age maximum: 40 Years
Gender: All

Health Condition(s) or Problem(s) studied

Osteosarcoma

Intervention(s)

Drug: Mifamurtide arm

Other: 3 drugs arm

Primary Outcome(s)

Events free survival [Time Frame: 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).]

Secondary Outcome(s)

Overall Survival [Time Frame: 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).]

Secondary ID(s)

2011-001659-36

ISG/OS-2

Source(s) of Monetary Support

Please refer to primary and secondary sponsors