ABCB1/P-glycoprotein Expression as Biologic Stratification Factor for Patients With Non Metastati… (NCT01459484) | Clinical Trial Compass
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 range
40 Years
Sex
ALL
See this in plain English?
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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).