Study of Effectiveness of GEMDOX in Relapsed Osteosarcoma

November 24, 2021 updated by: Prof. Franca Fagioli, Azienda Ospedaliera Ospedale Infantile Regina Margherita Sant'Anna

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

33

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Bologna, Italy, 40136
        • Istituto Ortopedico Rizzoli
      • Florence, Italy, 50134
        • AOUC Azienda Ospedaliero-Universitaria Careggi
      • Milan, Italy, 20133
        • IRCCS Istituto Nazionale dei Tumori
      • Pisa, Italy
        • Azienda Ospedaliero Universitaria Pisana
      • Rome, Italy, 00144
        • IRCCS Istituti Fisioterapici Ospitalieri
      • Turin, Italy, 10126
        • AOU Città della Salute e della Scienza di Torino - Presidio Infantile Regina Margherita
    • Milano
      • Milan, Milano, Italy, 20133
        • Istituto Nazionale Tumori
    • Turin
      • Candiolo, Turin, Italy, 10060
        • Fondazione del Piemonte per l' Oncologia IRCCS Candiolo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

patients with relapsed osteosarcoma treated with gemcitabine- docetaxel after a first line with HD- IFO

Description

Inclusion Criteria:

  • 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 :

    1. Relapsed in the first 24 month following the initial diagnosis, regardless of location and resectability
    2. Lung relapsed disease with more than 2 nodules diagnosed over 24 months from the initial diagnosis
    3. 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

Exclusion Criteria: none

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Response to Gemcitabina - Docetaxel Treatment
Time Frame: 12 months
assessed as overall survival (12 months)
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Azienda Ospedaliera Ospedale Infantile Regina Margherita Sant'Anna

Investigators

  • Principal Investigator: Franca Fagioli, MD, AOU Città della Salute e della Scienza di Torino - Presidio Infantile Regina Margherita

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 24, 2020

Primary Completion (Actual)

June 6, 2021

Study Completion (Actual)

November 23, 2021

Study Registration Dates

First Submitted

November 24, 2020

First Submitted That Met QC Criteria

December 2, 2020

First Posted (Actual)

December 3, 2020

Study Record Updates

Last Update Posted (Actual)

November 26, 2021

Last Update Submitted That Met QC Criteria

November 24, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OSTEOREC/OSS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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