NCT04651569

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2020

Typical duration for all trials

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 2, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 25, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 3, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

May 25, 2023

Status Verified

May 1, 2023

Enrollment Period

9 months

First QC Date

November 25, 2020

Last Update Submit

May 24, 2023

Conditions

Osteosarcoma Recurrent

Outcome Measures

Primary Outcomes (3)

  • Progression Free Survival

    Disease remission or disease progression

    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)

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

  • toxicity according to CTCAE v.5.0

    Disease evaluation

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

Interventions

Observational studyOTHER

none, Observational study

Eligibility Criteria

AgeUp to 40 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

patients with relapsed/ refractory osteosarcom

You may qualify if:

  • 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

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Istituto Ortopedico Rizzoli

Bologna, 40136, Italy

Location

Azienda Ospedaliero Universitaria Meyer

Florence, 50139, Italy

Location

IRCCS Istituto Nazionale dei Tumori - S.C. Pediatria

Milan, 20133, Italy

Location

Regina Elena National Cancer Institute IRCCS

Roma, 00144, Italy

Location

OIRM - AOU Città della Salute e della Scienza di Torino

Torino, 10126, Italy

Location

MeSH Terms

Interventions

Observation

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Study Officials

  • Celeste Cagnazzo, PhD

    A.O.U. Città della Salute e della Scienza

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 25, 2020

First Posted

December 3, 2020

Study Start

October 2, 2020

Primary Completion

June 30, 2021

Study Completion

December 31, 2022

Last Updated

May 25, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations

IT(5)