Know Cancer

or
forgot password

ABCB1/P-glycoprotein Expression as Biologic Stratification Factor for Patients With Non Metastatic Osteosarcoma - Prospective Study (ISG/OS-2)


Phase 2/Phase 3
40 Years
N/A
Open (Enrolling)
Both
Osteosarcoma

Thank you

Trial Information

ABCB1/P-glycoprotein Expression as Biologic Stratification Factor for Patients With Non Metastatic Osteosarcoma - Prospective Study (ISG/OS-2)


The Primary objective is:

* Overall survival in patient with non metastatic osteosarcoma of the extremities treated
with different chemotherapy approach (5 drugs vs 3 drugs), according to the expression of
ABCB1/P-glycoprotein

The Secondary objectives are:

- to assess the survival in patient who over express ABCB1/P-glycoprotein, with
chemotherapy protocol based on all the 5 available active drugs (Methotrexate,
cisplatinum, doxorubicine, ifosfamide and mifamurtide)

- to assess the survival in patient who do not over express ABCB1/P-glycoprotein


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall Survival

Outcome Description:

The Overall Survival will be evaluated at the end of the study period (5 enrollment years and 2 years - minimum- follow-up from the last enrolled patient)

Outcome Time Frame:

The patients will be followed in term of Overall Survival, for all the study period (expected average: 7 years)

Safety Issue:

No

Principal Investigator

Stefano Ferrari, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Italian Sarcoma Group

Authority:

Italy: Ethics Committee

Study ID:

ISG/OS-2

NCT ID:

NCT01459484

Start Date:

July 2011

Completion Date:

July 2019

Related Keywords:

  • Osteosarcoma
  • Non metastatic extremities high grade osteosarcoma
  • Osteosarcoma

Name

Location