Study of Effectiveness of GEMDOX in Relapsed Osteosarcoma

NCT ID: NCT04651179

Last Updated: 2021-11-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

33 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-04-24

Study Completion Date

2021-11-23

Brief Summary

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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

Detailed Description

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Conditions

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Osteosarcoma Recurrent Osteosarcoma Metastatic

Study Design

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Observational Model Type

OTHER

Study Time Perspective

RETROSPECTIVE

Interventions

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observation

not applicable, observational study

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

4 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Azienda Ospedaliera Ospedale Infantile Regina Margherita Sant'Anna

OTHER

Sponsor Role lead

Responsible Party

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Prof. Franca Fagioli

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Franca Fagioli, MD

Role: PRINCIPAL_INVESTIGATOR

AOU Città della Salute e della Scienza di Torino - Presidio Infantile Regina Margherita

Locations

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Istituto Nazionale Tumori

Milan, Milano, Italy

Site Status

Fondazione del Piemonte per l' Oncologia IRCCS Candiolo

Candiolo, Turin, Italy

Site Status

Istituto Ortopedico Rizzoli

Bologna, , Italy

Site Status

AOUC Azienda Ospedaliero-Universitaria Careggi

Florence, , Italy

Site Status

IRCCS Istituto Nazionale dei Tumori

Milan, , Italy

Site Status

Azienda Ospedaliero Universitaria pisana

Pisa, , Italy

Site Status

IRCCS Istituti Fisioterapici Ospitalieri

Rome, , Italy

Site Status

AOU Città della Salute e della Scienza di Torino - Presidio Infantile Regina Margherita

Turin, , Italy

Site Status

Countries

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Italy

Other Identifiers

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OSTEOREC/OSS

Identifier Type: -

Identifier Source: org_study_id