NCT01459484CompletedPhase 2
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)
Source: ClinicalTrials.gov · Last updated 20 May 2024
Brief summary (registry, in English)
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
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 225 (actual)
- First submitted
- 19 Oct 2011
- Start date
- 23 Jun 2011
- Primary completion date
- 30 Apr 2024
- Lead sponsor
- Italian Sarcoma Group
- Diseases
- Childhood cancers, Sarcoma
- NCT number
- NCT01459484
- EudraCT number
- 2011-001659-36
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 225
- From 23 Jun 2011 to the primary completion date, 30 Apr 2024
- 11 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Medical contra-indication to the drugs foreseen in the protocol,
Other illness
- Mental or social conditions that can compromise a correct adherence to the protocol and its procedures
Other
- Presence of metastases other than skip metastases
- Periosteal Osteosarcoma, parostal osteosarcoma, secondary osteosarcoma,
- Subject is pregnant or breast feeding
Who the study is looking for
- 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.
Age in the registry: - to 40 years · Sex: All · Does not accept healthy volunteers
Sites (11)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| IRCCS Istituto ortopedico Rizzoli Coordinator of this site? Confirm its status | Bologna | Italy | Unknown status |
| I.R.C.C. - Unit of Medical Oncology Coordinator of this site? Confirm its status | Candiolo | Italy | Unknown status |
| A.O. Universitaria Meyer Coordinator of this site? Confirm its status | Florence | Italy | Unknown status |
| Istituto Giannina Gaslini Coordinator of this site? Confirm its status | Genova | Italy | Unknown status |
| Fondazione IRCCS - Istituto Nazionale dei Tumori Coordinator of this site? Confirm its status | Milan | Italy | Unknown status |
| Istituto Nazionale Tumori Fondazione G. Pascale Coordinator of this site? Confirm its status | Naples | Italy | Unknown status |
| Azienda Ospedaliera di Padova Coordinator of this site? Confirm its status | Padova | Italy | Unknown status |
| Istituti Fisioterapici Ospitalieri di Roma Coordinator of this site? Confirm its status | Roma | Italy | Unknown status |
| Ospedale Pediatrico Bambin Gesu' Coordinator of this site? Confirm its status | Roma | Italy | Unknown status |
| Presidio Sanitario Gradenigo Coordinator of this site? Confirm its status | Torino | Italy | Unknown status |
| Ospedale Infantile Regina Margherita - Unit of Paediatric Oncoematology Coordinator of this site? Confirm its status | Torino | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.