ISG Os2Oss: Observational Study in Localized Osteosarcoma

• Sponsor: Italian Sarcoma Group (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT04890067
• Collaborator: Associazione Italiana Ematologia Oncologia Pediatrica (Other)
• Enrollment: 120
• Locations: 16
• Anticipated Duration (Months): 65
• Patients Per Site: 7.5
• Patients Per Site Per Month: 0.1

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Localized Osteosarcoma	Other: Treatment of Osteosarcoma according the AIEOP/ISG OS 2021 recommendations (includes drugs, surgery, radiotherapy or any other received treatments)

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.

Study Design

• Study Type: Observational
• Actual Enrollment: 120 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Multicenter Observational Study on the Treatment of Patients With Localized Osteosarcoma
• Actual Study Start Date: Jul 30, 2021
• Anticipated Primary Completion Date: Jun 30, 2026
• Anticipated Study Completion Date: Dec 30, 2026

Arms and Interventions

Arm	Intervention/Treatment
Localized Osteosarcoma This cohort include patients affected by localized Osteosarcoma, referred to participating Institutions.	Other: Treatment of Osteosarcoma according the AIEOP/ISG OS 2021 recommendations (includes drugs, surgery, radiotherapy or any other received treatments); 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

Outcome Measures

Primary Outcome Measures

1. 5 years Event Free Survival (EFS) [5 years]

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

Secondary Outcome Measures

1. Overall Survival (OS) [at 5 years]

   Time elapsed for the diagnosis to the death for any cause

2. Adverse events related to the treatments [Every 3 weeks (Week 3, week 6, week 9, week 12, ...) up to 36 months]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 40 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Centro di Riferimento Oncologico - Unit of Medical Oncology	Aviano	Pordenone	Italy	33081
2	Fondazione del Piemonte per l'Oncologia IRCC Candiolo	Candiolo	Torino	Italy	10060
3	IRCCS materno infantile Burlo Garofolo	Trieste	T	Italy	34137
4	Azienda Ospedaliero Universitaria Consorziale Policlinico - Bari	Bari		Italy	70124
5	IRCCS Istituto ortopedico Rizzoli	Bologna		Italy	40136
6	A.O. Universitaria Policlinico S. Orsola Malpighi di Bologna	Bologna		Italy	40138
7	AUO Policnico G. Rodolico San Marco	Catania		Italy	95123
8	A.O. Universitaria Meyer	Firenze		Italy	50139
9	Istituto Giannina Gaslini	Genova		Italy
10	Fondazione IRCCS INT Milano SC Pediatria Oncologica	Milano		Italy
11	FONDAZIONE IRCCS Istituto Nazionale dei Tumori	Milano		Italy
12	Azienda Ospedaliera di Padova UOC Oncoematologia Pediatrica	Padova		Italy
13	ARNAS P. O. "Civico e Benfratelli"	Palermo		Italy	90127
14	Azienda Ospedaliero-Universitaria Pisana	Pisa		Italy	56126
15	Istituti Fisioterapici Ospitalieri di Roma	Roma		Italy
16	Ospedale Pediatrico Bambin Gesu'	Roma		Italy

Sponsors and Collaborators

• Italian Sarcoma Group
• Associazione Italiana Ematologia Oncologia Pediatrica

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

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• Responsible Party: Italian Sarcoma Group
• ClinicalTrials.gov Identifier: NCT04890067
• Other Study ID Numbers: AIEOP/ISGOS2 Oss
• First Posted: May 18, 2021
• Last Update Posted: Nov 5, 2021
• Last Verified: Oct 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Italian Sarcoma Group: Osteosarcoma
• Additional relevant MeSH terms: Osteosarcoma

Study Results

No Results Posted as of Nov 5, 2021