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OpenTrials
Completed

NCT Number: NCT04651179

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

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Key information

Conditions

Osteosarcoma Recurrent Osteosarcoma Metastatic

Age range

4 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Istituto Nazionale Tumori, Milan, Milano, Italy

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 :
  • 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

Exclusion criteria

none

Treatment and study plan

observation

Other

not applicable, observational study

Primary outcomes

  1. Response to Gemcitabina - Docetaxel Treatment

    Time frame: 12 months

    assessed as overall survival (12 months)

Sponsors and collaborators

Lead sponsor

Azienda Ospedaliera Ospedale Infantile Regina Margherita Sant'Anna

Other

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Dec 3, 2020
Registry last updated
Nov 26, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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