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

This study is currently recruiting participants.
Verified March 2017 by Italian Sarcoma Group
Sponsor:
ClinicalTrials.gov Identifier:
NCT01459484
First Posted: October 25, 2011
Last Update Posted: March 21, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Italian Sarcoma Group
October 19, 2011
October 25, 2011
March 21, 2017
July 2011
January 2020   (Final data collection date for primary outcome measure)
Overall Survival [ Time Frame: The patients will be followed in term of Overall Survival, for all the study period (expected average: 7 years) ]
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)
Overall Survival [ Time Frame: The patients will be followed in term of Overall Survival, for all the study period (expected average: 7 years) ]
The OS will be evaluated at the end of the study period (5 enrollment years and 2 years - minimum- follow-up from the last enrolled patient)
Complete list of historical versions of study NCT01459484 on ClinicalTrials.gov Archive Site
Events free survival in patient with ABCB1/P-glycoprotein over-expression, and who do not over-express ABCB1/P-glycoprotein [ Time Frame: after 2 and 3 years from the start of study ]
The events free survival will be evaluated by means of interim analysis after 2 and 3 years from the start of study. A further evaluation will be performed at the end of enrollment and after 2 years form the last enrolled patient.
Same as current
Not Provided
Not Provided
 
ABCB1/P-glycoprotein Expression as Biologic Stratification Factor for Patients With Non Metastatic Osteosarcoma
ABCB1/P-glycoprotein Expression as Biologic Stratification Factor for Patients With Non Metastatic Osteosarcoma - Prospective Study (ISG/OS-2)
The main objective of the study is to assess the survival in patient with non metastatic osteosarcoma of the extremities treated with different chemotherapy protocols, according to the expression of ABCB1/P-glycoprotein

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
Interventional
Phase 2
Phase 3
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Osteosarcoma
  • Drug: Mifamurtide 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

    Other Names:
    • Methotrexate
    • Cisplatinum
    • doxorubicin
    • ifosfamide
    • mifamurtide
  • Other: 3 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

    Other Names:
    • methotrexate
    • cisplatin
    • doxorubicine
  • Experimental: Mifamurtide arm
    Chemotherapy for patients who over express ABCB1/P-glycoprotein (methotrexate, cisplatinum, doxorubicine, ifosfamide + mifamurtide)
    Intervention: Drug: Mifamurtide arm
  • 3 drugs arm
    High grade osteosarcoma treatment for patients who do not over express ABCB1/P-glycoprotein
    Intervention: Other: 3 drugs arm
Serra M, Pasello M, Manara MC, Scotlandi K, Ferrari S, Bertoni F, Mercuri M, Alvegard TA, Picci P, Bacci G, Smeland S. May P-glycoprotein status be used to stratify high-grade osteosarcoma patients? Results from the Italian/Scandinavian Sarcoma Group 1 treatment protocol. Int J Oncol. 2006 Dec;29(6):1459-68.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
225
February 2020
January 2020   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
up to 40 Years   (Child, Adult)
No
Contact: Stefano Ferrari, MD +390516366 ext 411 stefano.ferrari@ior.it
Contact: Emanuela Marchesi, PhD +390516366 ext 400 emanuela.marchesi@ior.it
Italy
 
 
NCT01459484
ISG/OS-2
2011-001659-36 ( EudraCT Number )
Yes
Not Provided
Not Provided
Italian Sarcoma Group
Italian Sarcoma Group
Not Provided
Principal Investigator: Stefano Ferrari, MD Italian Sarcoma Group
Italian Sarcoma Group
March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP