CompletedPhase 2

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

Italy225 participantsStarted 2011-06-23

Plain-language 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

Who can participate

Age range40 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Events free survival

Timeframe: 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).

Trial details

NCT IDNCT01459484

SponsorItalian Sarcoma Group

Sponsor typeNETWORK

Study typeINTERVENTIONAL

Primary completion2024-04-30

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