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Observational Study in Localized Osteosarcoma

ConditionLocalized Osteosarcoma
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeUp to 40
SponsorItalian Sarcoma Group

About this trial

Observational prospective trial aimed to collect the collect demographic, clinical, surgical, pathological and molecular characteristics and treatment from patients affected by localized OsteoSarcoma (OS) treated according the AIEOP/Italian Sarcoma Group (ISG) OS 2021

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Diagnosis of high grade OS of the extremities

Age at diagnosis ≤ 40 years at the time of diagnosis

Localized disease (skip metastases are allowed)

Adequate organ function according the AIEOP/ISG OS 2021 recommendation

Disqualifiers

Presence of metastases

Diagnosis of periosteal OS, of parosteal OS or secondary OS

Any medical condition which can not allowed the use of the treatments recommended by AIEOP/ISG OS 2021

Trial population

Patients with localized high grade ostesarcoma of the extremities

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Treatment of Osteosarcoma according the AIEOP/ISG OS 2021 recommendations (includes drugs, surgery, radiotherapy or any other received treatments)

    Other intervention

    This observational study collects all the treatments received by the patients according according the AIEOP/ISG OS 2021 and therefore includes drug/biological/surgical/ radiotherapy and any other applicable treatments

Treatment groups

120 Participants
are divided into 1 treatment group
Group A: Localized Osteosarcoma1 intervention

Trial outcomes

Primary outcomes

1

5 years Event Free Survival (EFS)

Onset of any event (an event is the defined as disease recurrence, death for disease or any other cause)

Time frame
5 years

Secondary outcomes

1

Overall Survival (OS)

Time elapsed for the diagnosis to the death for any cause

Time frame
at 5 years
2

Adverse events related to the treatments

Number of Participants with Treatment-Related Adverse Events as Assessed by Common Terminology Criteria for Adverse Events version 5.0

Time frame
Every 3 weeks (Week 3, week 6, week 9, week 12, ...) up to 36 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Italian Sarcoma Group

Lead sponsor

Associazione Italiana Ematologia Oncologia Pediatrica

Collaborator

Source ClinicalTrials.gov
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