Clinical trial NCT04890067: Observational Study in Localized Osteosarcoma
Official title: Multicenter Observational Study on the Treatment of Patients With Localized Osteosarcoma
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Localized Osteosarcoma
Keywords: Osteosarcoma
Lead sponsor: Italian Sarcoma Group
Sponsor class: NETWORK
Collaborators: name: Associazione Italiana Ematologia Oncologia Pediatrica
First posted: 2021-05-18
Enrollment: 120
Sex: ALL
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with localized high grade ostesarcoma of the extremities

Brief summary: 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

Detailed description: Osteosarcoma is the most frequent primary malignant bone tumor in children and adolescents and is considered a rare disease.

The overall incidence of OS is 0.2-3 / 100,000 inhabitants per year with a bimodal distribution by age, with a first peak in adolescence.

Currently, the treatment strategy for localized OS includes courses of neo-adjuvant chemotherapy based on 3 agents: Adriamycin (ADM), cisplatin (CDP) and high dose methotrexate (HDMTX) followed by surgical removal of the primary tumor and subsequent adjuvant chemotherapy treatment.

The MAP (Methotrexate, Adriamycin, cisPlatin) regimen, with or without ifosfamide (IFO) and etoposide (ETO), is considered the "gold standard" for the treatment of localized osteosarcoma.

Given the rarity of the disease, it is considered appropriate to collect information prospectively on the diagnosis, chemotherapy and surgical treatment and outcomes on patients treated by the network of AIEOP and ISG Centers according to the recommendations on the treatment of localized OS AIEOP/ISG OS 2021.

This study will be active up to the next interventional prospective protocol aimed at the therapy of high-grade, non-metastatic OS.

Eligibility criteria: Inclusion Criteria:

* 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
* Patients or parents oe guardians of minors who have given their written informed consent to participate in the study

Exclusion Criteria:

* 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

Primary outcomes:
measure: 5 years Event Free Survival (EFS)
timeFrame: 5 years
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: at 5 years
measure: Adverse events related to the treatments
timeFrame: Every 3 weeks (Week 3, week 6, week 9, week 12, ...) up to 36 months
Other outcomes:
Locations:
city: Aviano
country: Italy
facility: Centro di Riferimento Oncologico - Unit of Medical Oncology
state: Pordenone
city: Candiolo
country: Italy
facility: Sandra Aliberti
state: Torino
city: Trieste
country: Italy
facility: IRCCS materno infantile Burlo Garofolo
state: T
city: Bari
country: Italy
facility: Azienda Ospedaliero Universitaria Consorziale Policlinico - Bari
city: Bologna
country: Italy
facility: IRCCS Istituto ortopedico Rizzoli
city: Bologna
country: Italy
facility: A.O. Universitaria Policlinico S. Orsola Malpighi di Bologna
city: Catania
country: Italy
facility: AUO Policnico G. Rodolico San Marco
city: Firenze
country: Italy
facility: A.O. Universitaria Meyer
city: Genova
country: Italy
facility: Istituto Giannina Gaslini
city: Milano
country: Italy
facility: Fondazione IRCCS INT Milano SC Pediatria Oncologica
city: Milano
country: Italy
facility: FONDAZIONE IRCCS Istituto Nazionale dei Tumori
city: Padova
country: Italy
facility: Azienda Ospedaliera di Padova UOC Oncoematologia Pediatrica
city: Palermo
country: Italy
facility: ARNAS P. O. "Civico e Benfratelli"
city: Pisa
country: Italy
facility: Azienda Ospedaliero-Universitaria Pisana
city: Roma
country: Italy
facility: Istituti Fisioterapici Ospitalieri di Roma
city: Roma
country: Italy
facility: Ospedale Pediatrico Bambin Gesu'
Study officials:
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