Study of Effectiveness of GEMDOX in Relapsed Osteosarcoma

Completed

• Conditions: Osteosarcoma Recurrent; Osteosarcoma Metastatic

• Registration Number: NCT04651179
• Lead Sponsor: Azienda Ospedaliera Ospedale Infantile Regina Margherita Sant'Anna

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

Detailed Description

Not available

Study Timeline

• Study Start: 2020-04-24
• Study First Submitted: 2020-11-24
• Study First Submitted QC: 2020-12-02
• Study First Posted: 2020-12-03
• Primary Completion: 2021-06-06
• Status Verified: 2021-11
• Study Completion: 2021-11-23
• Last Update Submitted: 2021-11-24
• Last Update Posted: 2021-11-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Response to Gemcitabina - Docetaxel Treatment	12 months	assessed as overall survival (12 months)

Trial Locations

Locations (8)

AOUC Azienda Ospedaliero-Universitaria Careggi; 🇮🇹 Florence, Italy

IRCCS Istituto Nazionale dei Tumori; 🇮🇹 Milan, Italy

Istituto Nazionale Tumori; 🇮🇹 Milan, Milano, Italy

Fondazione del Piemonte per l' Oncologia IRCCS Candiolo; 🇮🇹 Candiolo, Turin, Italy

Istituto Ortopedico Rizzoli; 🇮🇹 Bologna, Italy

AOU Città della Salute e della Scienza di Torino - Presidio Infantile Regina Margherita; 🇮🇹 Turin, Italy

Azienda Ospedaliero Universitaria pisana; 🇮🇹 Pisa, Italy

IRCCS Istituti Fisioterapici Ospitalieri; 🇮🇹 Rome, Italy