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Completed

NCT Number: NCT04651569

An Analysis of the Efficacy of High Dose Isofosfamide Through Elastomer

A multicentre, observational, retrospective study to analyse the efficacy of high dose isofosfamide thorugh elastomer in patients with relapsed/ refractory osteosarcoma

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Key information

Conditions

Osteosarcoma Recurrent

Age range

Up to 40 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Istituto Ortopedico Rizzoli, Bologna, Italy

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Diagnosis of high risk relapsed/ refractory osteosarcoma
  • Aged <= 40 years at the beginning of treatment
  • at least one completed cycle of HD IFO through elastomer (14g/mq) in 14 days
  • disease evaluation according to RECIST criteria v.1.1

Exclusion criteria

  • none

Treatment and study plan

observational study

Other

none, Observational study

Primary outcomes

  1. Progression Free Survival

    Time frame: Evaluated during the first 4 months at the end of treatment

    Disease remission or disease progression

  2. growth modulation index - GMI

    Time frame: Evaluation to be recorded at each disease assessment through imaging (PET/CT/MRI)

    ratio of time to progression (TTP) with nth line of therapy (TTPn) to the most recent prior line of therapy (TTPn-1)

  3. toxicity according to CTCAE v.5.0

    Time frame: Evaluation to be recorded at each disease assessment through imaging (PET/CT/MRI)

    Disease evaluation

Sponsors and collaborators

Lead sponsor

Azienda Ospedaliera Ospedale Infantile Regina Margherita Sant'Anna

Other

Registry information

Official study title

A Multicentre, Retrospective, Observational Study to Analyse the Efficacy of High Dose Isofosfamide Administered Through Elastomer in Patients With Relapsed/ Refractory Osteosarcoma

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Dec 3, 2020
Registry last updated
May 25, 2023

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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