Study of Effectiveness of GEMDOX in Relapsed Osteosarcoma

Osteosarcoma Recurrent Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04651179
• Other study ID #: OSTEOREC/OSS
• Status: Completed
• Start date: April 24, 2020
• Est. completion date: November 23, 2021

Study information

• Verified date: November 2021
• Source: Azienda Ospedaliera Ospedale Infantile Regina Margherita Sant'Anna
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: November 23, 2021
• Est. primary completion date: June 6, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Osteosarcoma
• Osteosarcoma Metastatic
• Osteosarcoma Recurrent

Intervention

Other:
• observation
not applicable, observational study

Locations

Country	Name	City	State
Italy	Istituto Ortopedico Rizzoli	Bologna
Italy	Fondazione del Piemonte per l' Oncologia IRCCS Candiolo	Candiolo	Turin
Italy	AOUC Azienda Ospedaliero-Universitaria Careggi	Florence
Italy	IRCCS Istituto Nazionale dei Tumori	Milan
Italy	Istituto Nazionale Tumori	Milan	Milano
Italy	Azienda Ospedaliero Universitaria pisana	Pisa
Italy	IRCCS Istituti Fisioterapici Ospitalieri	Rome
Italy	AOU Città della Salute e della Scienza di Torino - Presidio Infantile Regina Margherita	Turin

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliera Ospedale Infantile Regina Margherita Sant'Anna

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response to Gemcitabina - Docetaxel Treatment	assessed as overall survival (12 months)	12 months