An Analysis of the Efficacy of High Dose Isofosfamide Through Elastomer

Azienda Ospedaliera Ospedale Infantile Regina Margherita Sant'Anna26 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

Conditions

Osteosarcoma Recurrent

Interventions

Observational studyOTHER

none, Observational study

Eligibility

Sex: ALLMax age: 40 Years

Medical Language ↔ Plain English

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

Locations (5)

Istituto Ortopedico Rizzoli

Bologna, Italy

Azienda Ospedaliero Universitaria Meyer

Florence, Italy

IRCCS Istituto Nazionale dei Tumori - S.C. Pediatria

Milan, Italy

Regina Elena National Cancer Institute IRCCS

Roma, Italy

Outcomes

Primary Outcomes

Progression Free Survival

Disease remission or disease progression

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

growth modulation index - GMI

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

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

toxicity according to CTCAE v.5.0

Disease evaluation

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

Data from ClinicalTrials.gov

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