Study of Effectiveness of GEMDOX in Relapsed Osteosarcoma
A Retrospective Observational Study of the Effectiveness of Gemcitabine -Docetaxel in Patients With Relapsed Osteosarcoma Who Have Been Treated With HD-IFO in First Line Treatment
1 other identifier
observational
33
1 country
8
Brief Summary
A retrospective observational study of the effectiveness of gemcitabine - docetaxel in patients with relapsed osteosarcoma who have been treated with HD IFO in first line treatment
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Apr 2020
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 24, 2020
CompletedFirst Submitted
Initial submission to the registry
November 24, 2020
CompletedFirst Posted
Study publicly available on registry
December 3, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 6, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
November 23, 2021
CompletedNovember 26, 2021
November 1, 2021
1.1 years
November 24, 2020
November 24, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Response to Gemcitabina - Docetaxel Treatment
assessed as overall survival (12 months)
12 months
Interventions
not applicable, observational study
Eligibility Criteria
patients with relapsed osteosarcoma treated with gemcitabine- docetaxel after a first line with HD- IFO
You may qualify if:
- Age at diagnosis of high grade osteosarcoma \>= 4
- Received first line treatment with HD IFO
- Following HD IFO treatment, they have been diagnosed refractory disease and they satisfy at least one of the following criteria :
- Relapsed in the first 24 month following the initial diagnosis, regardless of location and resectability
- Lung relapsed disease with more than 2 nodules diagnosed over 24 months from the initial diagnosis
- Non resectable relapsed disease diagnosed over 24 months from the initial diagnosis Before or during GEMDOX treatment, eligible patients may have been subject to metastasectomy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
Istituto Nazionale Tumori
Milan, Milano, 20133, Italy
Fondazione del Piemonte per l' Oncologia IRCCS Candiolo
Candiolo, Turin, 10060, Italy
Istituto Ortopedico Rizzoli
Bologna, 40136, Italy
AOUC Azienda Ospedaliero-Universitaria Careggi
Florence, 50134, Italy
IRCCS Istituto Nazionale dei Tumori
Milan, 20133, Italy
Azienda Ospedaliero Universitaria pisana
Pisa, Italy
IRCCS Istituti Fisioterapici Ospitalieri
Rome, 00144, Italy
AOU Città della Salute e della Scienza di Torino - Presidio Infantile Regina Margherita
Turin, 10126, Italy
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Franca Fagioli, MD
AOU Città della Salute e della Scienza di Torino - Presidio Infantile Regina Margherita
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
November 24, 2020
First Posted
December 3, 2020
Study Start
April 24, 2020
Primary Completion
June 6, 2021
Study Completion
November 23, 2021
Last Updated
November 26, 2021
Record last verified: 2021-11
Data Sharing
- IPD Sharing
- Will not share