Observational Study in Localized Osteosarcoma

Localized Osteosarcoma Clinical Trial

— ISG Os2Oss  

Official title:

Multicenter Observational Study on the Treatment of Patients With Localized Osteosarcoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04890067
• Other study ID #: AIEOP/ISGOS2 Oss
• Status: Recruiting
• Start date: July 30, 2021
• Est. completion date: December 30, 2026

Study information

• Verified date: September 2023
• Source: Italian Sarcoma Group
• Contact: Franca Fagioli, MD/Prof
• Phone: 0039-0113135
• Email: franca.fagioli[@]unito.it
• Is FDA regulated: No
• Study type: Observational

Clinical 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 30, 2026
• Est. primary completion date: June 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Localized Osteosarcoma
• Osteosarcoma

Intervention

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

Locations

Country	Name	City	State
Italy	Centro di Riferimento Oncologico - Unit of Medical Oncology	Aviano	Pordenone
Italy	Azienda Ospedaliero Universitaria Consorziale Policlinico - Bari	Bari
Italy	A.O. Universitaria Policlinico S. Orsola Malpighi di Bologna	Bologna
Italy	IRCCS Istituto ortopedico Rizzoli	Bologna
Italy	Sandra Aliberti	Candiolo	Torino
Italy	AUO Policnico G. Rodolico San Marco	Catania
Italy	A.O. Universitaria Meyer	Firenze
Italy	Istituto Giannina Gaslini	Genova
Italy	Fondazione IRCCS INT Milano SC Pediatria Oncologica	Milano
Italy	FONDAZIONE IRCCS Istituto Nazionale dei Tumori	Milano
Italy	Azienda Ospedaliera di Padova UOC Oncoematologia Pediatrica	Padova
Italy	ARNAS P. O. "Civico e Benfratelli"	Palermo
Italy	Azienda Ospedaliero-Universitaria Pisana	Pisa
Italy	Istituti Fisioterapici Ospitalieri di Roma	Roma
Italy	Ospedale Pediatrico Bambin Gesu'	Roma
Italy	IRCCS materno infantile Burlo Garofolo	Trieste	T

Sponsors (2)

Lead Sponsor	Collaborator
Italian Sarcoma Group	Associazione Italiana Ematologia Oncologia Pediatrica

Country where clinical trial is conducted

Italy, 

References & Publications (34)

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Ferrari S, Bacci G, Picci P, Mercuri M, Briccoli A, Pinto D, Gasbarrini A, Tienghi A, Brach del Prever A. Long-term follow-up and post-relapse survival in patients with non-metastatic osteosarcoma of the extremity treated with neoadjuvant chemotherapy. Ann Oncol. 1997 Aug;8(8):765-71. doi: 10.1023/a:1008221713505. — View Citation

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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. — View Citation

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Isakoff MS, Bielack SS, Meltzer P, Gorlick R. Osteosarcoma: Current Treatment and a Collaborative Pathway to Success. J Clin Oncol. 2015 Sep 20;33(27):3029-35. doi: 10.1200/JCO.2014.59.4895. Epub 2015 Aug 24. — View Citation

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Marina NM, Smeland S, Bielack SS, Bernstein M, Jovic G, Krailo MD, Hook JM, Arndt C, van den Berg H, Brennan B, Brichard B, Brown KLB, Butterfass-Bahloul T, Calaminus G, Daldrup-Link HE, Eriksson M, Gebhardt MC, Gelderblom H, Gerss J, Goldsby R, Goorin A, Gorlick R, Grier HE, Hale JP, Hall KS, Hardes J, Hawkins DS, Helmke K, Hogendoorn PCW, Isakoff MS, Janeway KA, Jurgens H, Kager L, Kuhne T, Lau CC, Leavey PJ, Lessnick SL, Mascarenhas L, Meyers PA, Mottl H, Nathrath M, Papai Z, Randall RL, Reichardt P, Renard M, Safwat AA, Schwartz CL, Stevens MCG, Strauss SJ, Teot L, Werner M, Sydes MR, Whelan JS. Comparison of MAPIE versus MAP in patients with a poor response to preoperative chemotherapy for newly diagnosed high-grade osteosarcoma (EURAMOS-1): an open-label, international, randomised controlled trial. Lancet Oncol. 2016 Oct;17(10):1396-1408. doi: 10.1016/S1470-2045(16)30214-5. Epub 2016 Aug 25. — View Citation

Meyers PA, Schwartz CL, Krailo M, Kleinerman ES, Betcher D, Bernstein ML, Conrad E, Ferguson W, Gebhardt M, Goorin AM, Harris MB, Healey J, Huvos A, Link M, Montebello J, Nadel H, Nieder M, Sato J, Siegal G, Weiner M, Wells R, Wold L, Womer R, Grier H. Osteosarcoma: a randomized, prospective trial of the addition of ifosfamide and/or muramyl tripeptide to cisplatin, doxorubicin, and high-dose methotrexate. J Clin Oncol. 2005 Mar 20;23(9):2004-11. doi: 10.1200/JCO.2005.06.031. — View Citation

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Smeland S, Bielack SS, Whelan J, Bernstein M, Hogendoorn P, Krailo MD, Gorlick R, Janeway KA, Ingleby FC, Anninga J, Antal I, Arndt C, Brown KLB, Butterfass-Bahloul T, Calaminus G, Capra M, Dhooge C, Eriksson M, Flanagan AM, Friedel G, Gebhardt MC, Gelderblom H, Goldsby R, Grier HE, Grimer R, Hawkins DS, Hecker-Nolting S, Sundby Hall K, Isakoff MS, Jovic G, Kuhne T, Kager L, von Kalle T, Kabickova E, Lang S, Lau CC, Leavey PJ, Lessnick SL, Mascarenhas L, Mayer-Steinacker R, Meyers PA, Nagarajan R, Randall RL, Reichardt P, Renard M, Rechnitzer C, Schwartz CL, Strauss S, Teot L, Timmermann B, Sydes MR, Marina N. Survival and prognosis with osteosarcoma: outcomes in more than 2000 patients in the EURAMOS-1 (European and American Osteosarcoma Study) cohort. Eur J Cancer. 2019 Mar;109:36-50. doi: 10.1016/j.ejca.2018.11.027. Epub 2019 Jan 25. — View Citation

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* Note: There are 34 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	5 years
Secondary	Overall Survival (OS)	Time elapsed for the diagnosis to the death for any cause	at 5 years
Secondary	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	Every 3 weeks (Week 3, week 6, week 9, week 12, ...) up to 36 months