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Localized OsteosarcomaISG Os2OssNCT04890067

Observational Study in Localized Osteosarcoma

An observational study of Localized Osteosarcoma, run by Italian Sarcoma Group at 16 sites in Italy.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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 Read more about this study

Who is it for?
Ages Up to 40 years
Conditions the study is for
Localized Osteosarcoma
What is being tested?
Treatment of Osteosarcoma according the AIEOP/ISG OS 2021 recommendations (includes drugs, surgery, radiotherapy or any other received treatments)
How many people
120 participants
Where
16 sitesItaly
Study dates
30 Jul 2021to 30 Dec 2026
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 40 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Study population: Patients with localized high grade ostesarcoma of the extremities

Who may be able to join

  • 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

Who cannot join

  • 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 locations and contacts

16 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Franca Fagioli, MD/Prof contact

0039-0113135 ext. 151

franca.fagioli@unito.it

Sebastian D Asaftei, MD contact

0039-011 3135 ext. 998

sebastiandorin.asaftei@unito.it

16 sites in 1 country

Italy16 sites, 16 recruiting

  • Centro di Riferimento Oncologico - Unit of Medical Oncology

    Aviano, Pordenone, 33081

    Maurizio Mascarin, MD, +390434659 ext. 536, mascarin@cro.it

    Maurizio Mascarin, MD

    Recruiting

  • Azienda Ospedaliero Universitaria Consorziale Policlinico - Bari

    Bari, 70124

    Francesco De Leonardis, MD, 00390805592 ext. 137, francesco.deleonardis@policlinico.ba.it

    Francesco De Leonardis, MD

    Recruiting

  • IRCCS Istituto ortopedico Rizzoli

    Bologna, 40136

    Toni Ibrahim, MD

    Michela Pierini, PhD, +390516366 ext. 668, michela.pierini@ior.it

    Recruiting

  • A.O. Universitaria Policlinico S. Orsola Malpighi di Bologna

    Bologna, 40138

    Arcangelo Prete, MD, +390516363 ext. 111, tmoped@aosp.bo.it

    Arcangelo Prete, MD

    Recruiting

  • Sandra Aliberti

    Candiolo, Torino, 10060

    Sandra Aliberti, MD, 0039-011-993 ext. 3623, sandra.aliberti@ircc.it

    Giovanni Grignani, MD

    Recruiting

  • AUO Policnico G. Rodolico San Marco

    Catania, 95123

    Andrea Di Cataldo, MD

    adicata@unict.it

    Recruiting

  • A.O. Universitaria Meyer

    Florence, 50139

    Angela Tamburini, MD, +3905556 ext. 621, a.tamburini@meyer.it

    Angela Tamburini, MD

    Recruiting

  • Istituto Giannina Gaslini

    Genova

    Carla Manzitti, MD

    "manzitti carla" <carlamanzitti@gaslini.org>

    Recruiting

  • Fondazione IRCCS INT Milano SC Pediatria Oncologica

    Milan

    Cristina Meazza, MD, +390223903

    cristina.meazza@istitutotumori.mi.it

    Recruiting

  • FONDAZIONE IRCCS Istituto Nazionale dei Tumori

    Milan

    Rossella Bertulli, MD

    rossella.bertulli@istitutotumori.mi.it

    Recruiting

  • Azienda Ospedaliera di Padova UOC Oncoematologia Pediatrica

    Padova

    Gianni Bisogno, MD

    gianni.bisogno@unipd.it

    Recruiting

  • ARNAS P. O. "Civico e Benfratelli"

    Palermo, 90127

    Paolo D'Angelo, MD, 039 091666 ext. 4316, oncoematologia.ped@arnascivico.it

    Recruiting

  • Azienda Ospedaliero-Universitaria Pisana

    Pisa, 56126

    Luca Coccoli, MD, 0039050992 ext. 840, l.coccoli@ao-pisa.toscana.it

    Luca Coccoli, MD

    Recruiting

  • Istituti Fisioterapici Ospitalieri di Roma

    Roma

    Virginia Ferraresi, MD

    virginia.ferraresi@ifo.gov.it

    Recruiting

  • Ospedale Pediatrico Bambin Gesu'

    Roma

    Giuseppe Maria Milano, MD, 06 68591 ext. 111, giuseppemaria.milano@opbg.net

    Giuseppe Maria Milano, MD

    Not yet recruiting

  • IRCCS materno infantile Burlo Garofolo

    Trieste, T, 34137

    Marco Rabusin, MD, 040.3785 ext. 563, marco.rabusin@burlo.trieste.it

    Marco Rabusin, MD

    Recruiting

Other trials in Italy

About this study

Official title: Multicenter Observational Study on the Treatment of Patients With Localized Osteosarcoma

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

Read the 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.

Being tested
Treatment of Osteosarcoma according the AIEOP/ISG OS 2021 recommendations (includes drugs, surgery, radiotherapy or any other received treatments)
Keywords
Osteosarcoma
Medical subject headings
Osteosarcoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

    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

Study groups in NCT04890067
Study groupRoleWhat they receive
Localized OsteosarcomaThis cohort include patients affected by localized Osteosarcoma, referred to participating Institutions.
Receives: Other: Treatment of Osteosarcoma according the AIEOP/ISG OS 2021 recommendations (includes drugs, surgery, radiotherapy or any other received treatments)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: 5 years

Secondary outcomes (2)

  1. Overall Survival (OS)

    Time elapsed for the diagnosis to the death for any cause

    Measured: 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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 May 2021
  2. Study start30 Jul 2021
  3. Primary completion30 Sep 2026 (estimated)
  4. Study completion30 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04890067
Sponsor's protocol ID
AIEOP/ISGOS2 Oss
Acronym
ISG Os2Oss
Status last verified
Sep 2026
First submitted
12 May 2021
Last updated
2 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: No plan sharing

Publications

  • Mirabello L, Troisi RJ, Savage SA. Osteosarcoma incidence and survival rates from 1973 to 2004: data from the Surveillance, Epidemiology, and End Results Program. Cancer. 2009 Apr 1;115(7):1531-43. doi: 10.1002/cncr.24121.

    PubMed 19197972

  • Marina N, Gebhardt M, Teot L, Gorlick R. Biology and therapeutic advances for pediatric osteosarcoma. Oncologist. 2004;9(4):422-41. doi: 10.1634/theoncologist.9-4-422.

    PubMed 15266096

  • Casali PG, Bielack S, Abecassis N, Aro HT, Bauer S, Biagini R, Bonvalot S, Boukovinas I, Bovee JVMG, Brennan B, Brodowicz T, Broto JM, Brugieres L, Buonadonna A, De Alava E, Dei Tos AP, Del Muro XG, Dileo P, Dhooge C, Eriksson M, Fagioli F, Fedenko A, Ferraresi V, Ferrari A, Ferrari S, Frezza AM, Gaspar N, Gasperoni S, Gelderblom H, Gil T, Grignani G, Gronchi A, Haas RL, Hassan B, Hecker-Nolting S, Hohenberger P, Issels R, Joensuu H, Jones RL, Judson I, Jutte P, Kaal S, Kager L, Kasper B, Kopeckova K, Krakorova DA, Ladenstein R, Le Cesne A, Lugowska I, Merimsky O, Montemurro M, Morland B, Pantaleo MA, Piana R, Picci P, Piperno-Neumann S, Pousa AL, Reichardt P, Robinson MH, Rutkowski P, Safwat AA, Schoffski P, Sleijfer S, Stacchiotti S, Strauss SJ, Sundby Hall K, Unk M, Van Coevorden F, van der Graaf WTA, Whelan J, Wardelmann E, Zaikova O, Blay JY; ESMO Guidelines Committee, PaedCan and ERN EURACAN. Bone sarcomas: ESMO-PaedCan-EURACAN Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2018 Oct 1;29(Suppl 4):iv79-iv95. doi: 10.1093/annonc/mdy310. No abstract available.

    PubMed 30285218

  • Ottaviani G, Jaffe N. The epidemiology of osteosarcoma. Cancer Treat Res. 2009;152:3-13. doi: 10.1007/978-1-4419-0284-9_1.

    PubMed 20213383

  • Gatta G, Botta L, Rossi S, Aareleid T, Bielska-Lasota M, Clavel J, Dimitrova N, Jakab Z, Kaatsch P, Lacour B, Mallone S, Marcos-Gragera R, Minicozzi P, Sanchez-Perez MJ, Sant M, Santaquilani M, Stiller C, Tavilla A, Trama A, Visser O, Peris-Bonet R; EUROCARE Working Group. Childhood cancer survival in Europe 1999-2007: results of EUROCARE-5--a population-based study. Lancet Oncol. 2014 Jan;15(1):35-47. doi: 10.1016/S1470-2045(13)70548-5. Epub 2013 Dec 5.

    PubMed 24314616

  • Mirabello L, Troisi RJ, Savage SA. International osteosarcoma incidence patterns in children and adolescents, middle ages and elderly persons. Int J Cancer. 2009 Jul 1;125(1):229-34. doi: 10.1002/ijc.24320.

    PubMed 19330840

  • Geller DS, Gorlick R. Osteosarcoma: a review of diagnosis, management, and treatment strategies. Clin Adv Hematol Oncol. 2010 Oct;8(10):705-18.

    PubMed 21317869

  • Bielack SS, Kempf-Bielack B, Delling G, Exner GU, Flege S, Helmke K, Kotz R, Salzer-Kuntschik M, Werner M, Winkelmann W, Zoubek A, Jurgens H, Winkler K. Prognostic factors in high-grade osteosarcoma of the extremities or trunk: an analysis of 1,702 patients treated on neoadjuvant cooperative osteosarcoma study group protocols. J Clin Oncol. 2002 Feb 1;20(3):776-90. doi: 10.1200/JCO.2002.20.3.776.

    PubMed 11821461

  • Luetke A, Meyers PA, Lewis I, Juergens H. Osteosarcoma treatment - where do we stand? A state of the art review. Cancer Treat Rev. 2014 May;40(4):523-32. doi: 10.1016/j.ctrv.2013.11.006. Epub 2013 Nov 27.

    PubMed 24345772

  • Ferrari S, Ruggieri P, Cefalo G, Tamburini A, Capanna R, Fagioli F, Comandone A, Bertulli R, Bisogno G, Palmerini E, Alberghini M, Parafioriti A, Linari A, Picci P, Bacci G. Neoadjuvant chemotherapy with methotrexate, cisplatin, and doxorubicin with or without ifosfamide in nonmetastatic osteosarcoma of the extremity: an Italian sarcoma group trial ISG/OS-1. J Clin Oncol. 2012 Jun 10;30(17):2112-8. doi: 10.1200/JCO.2011.38.4420. Epub 2012 May 7.

    PubMed 22564997

  • Ferrari S, Meazza C, Palmerini E, Tamburini A, Fagioli F, Cozza R, Ferraresi V, Bisogno G, Mascarin M, Cefalo G, Manfrini M, Capanna R, Biagini R, Donati D, Picci P. Nonmetastatic osteosarcoma of the extremity. Neoadjuvant chemotherapy with methotrexate, cisplatin, doxorubicin and ifosfamide. An Italian Sarcoma Group study (ISG/OS-Oss). Tumori. 2014 Nov-Dec;100(6):612-9. doi: 10.1700/1778.19262.

    PubMed 25688494

  • Meyers PA, Schwartz CL, Krailo MD, Healey JH, Bernstein ML, Betcher D, Ferguson WS, Gebhardt MC, Goorin AM, Harris M, Kleinerman E, Link MP, Nadel H, Nieder M, Siegal GP, Weiner MA, Wells RJ, Womer RB, Grier HE; Children's Oncology Group. Osteosarcoma: the addition of muramyl tripeptide to chemotherapy improves overall survival--a report from the Children's Oncology Group. J Clin Oncol. 2008 Feb 1;26(4):633-8. doi: 10.1200/JCO.2008.14.0095.

    PubMed 18235123

  • Bacci G, Picci P, Ferrari S, Sangiorgi L, Zanone A, Brach del Prever A. Primary chemotherapy and delayed surgery for non-metastatic telangiectatic osteosarcoma of the extremities. Results in 28 patients. Eur J Cancer. 1994;30A(5):620-6. doi: 10.1016/0959-8049(94)90532-0.

    PubMed 8080676

  • Bacci G, Ferrari S, Mercuri M, Longhi A, Capanna R, Tienghi A, Brach del Prever A, Comandone A, Cesari M, Bernini G, Picci P. Neoadjuvant chemotherapy for extremity osteosarcoma--preliminary results of the Rizzoli's 4th study. Acta Oncol. 1998;37(1):41-8. doi: 10.1080/028418698423168.

    PubMed 9572653

  • Ferrari S, Smeland S, Mercuri M, Bertoni F, Longhi A, Ruggieri P, Alvegard TA, Picci P, Capanna R, Bernini G, Muller C, Tienghi A, Wiebe T, Comandone A, Bohling T, Del Prever AB, Brosjo O, Bacci G, Saeter G; Italian and Scandinavian Sarcoma Groups. Neoadjuvant chemotherapy with high-dose Ifosfamide, high-dose methotrexate, cisplatin, and doxorubicin for patients with localized osteosarcoma of the extremity: a joint study by the Italian and Scandinavian Sarcoma Groups. J Clin Oncol. 2005 Dec 1;23(34):8845-52. doi: 10.1200/JCO.2004.00.5785. Epub 2005 Oct 24.

    PubMed 16246977

Questions about this trial

What is this clinical trial studying?

An observational study of Localized Osteosarcoma, run by Italian Sarcoma Group at 16 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Franca Fagioli, MD/Prof (0039-0113135 ext. 151, franca.fagioli@unito.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

5 years Event Free Survival (EFS) (time frame: 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04890067, which also lists 34 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2026.

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