Observational Study in Localized Osteosarcoma (ISG Os2Oss)

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

Study Overview

• Status: Recruiting
• Conditions: Localized Osteosarcoma
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Estimated): 120

Contacts and Locations

• Study Contact: Name: Franca Fagioli, MD/Prof; Phone Number: 151 0039-0113135; Email: franca.fagioli@unito.it
• Study Contact Backup: Name: Sebastian D Asaftei, MD; Phone Number: 998 0039-011 3135; Email: sebastiandorin.asaftei@unito.it

Study Locations

• Italy
  • Bari, Italy, 70124
    • Recruiting
    • Azienda Ospedaliero Universitaria Consorziale Policlinico - Bari
    • Contact: Francesco De Leonardis, MD; Phone Number: 137 00390805592; Email: francesco.deleonardis@policlinico.ba.it
    • Principal Investigator: Francesco De Leonardis, MD
  • Bologna, Italy, 40136
    • Recruiting
    • Irccs Istituto Ortopedico Rizzoli
    • Contact: Michela Pierini, PhD; Phone Number: 668 +390516366; Email: michela.pierini@ior.it
    • Principal Investigator: Toni Ibrahim, MD
    • Contact: Toni Ibrahim, MD
  • Bologna, Italy, 40138
    • Recruiting
    • A.O. Universitaria Policlinico S. Orsola Malpighi di Bologna
    • Contact: Arcangelo Prete, MD; Phone Number: 111 +390516363; Email: tmoped@aosp.bo.it
    • Principal Investigator: Arcangelo Prete, MD
  • Catania, Italy, 95123
    • Recruiting
    • AUO Policnico G. Rodolico San Marco
    • Contact: Andrea Di Cataldo, MD
    • Contact: Email: adicata@unict.it
  • Florence, Italy, 50139
    • Recruiting
    • A.O. Universitaria Meyer
    • Contact: Angela Tamburini, MD; Phone Number: 621 +3905556; Email: a.tamburini@meyer.it
    • Principal Investigator: Angela Tamburini, MD
  • Genova, Italy
    • Recruiting
    • Istituto Giannina Gaslini
    • Principal Investigator: Carla Manzitti, MD
    • Contact: Carla Manzitti, MD
    • Contact: Email: "manzitti carla" <carlamanzitti@gaslini.org>
  • Milan, Italy
    • Recruiting
    • Fondazione IRCCS Istituto Nazionale dei Tumori
    • Principal Investigator: Rossella Bertulli, MD
    • Contact: Rossella Bertulli, MD
    • Contact: Email: rossella.bertulli@istitutotumori.mi.it
  • Milan, Italy
    • Recruiting
    • Fondazione IRCCS INT Milano SC Pediatria Oncologica
    • Contact: Cristina Meazza, MD; Phone Number: +390223903
    • Contact: Email: cristina.meazza@istitutotumori.mi.it
    • Principal Investigator: Cristina Meazza, MD
  • Padua, Italy
    • Recruiting
    • Azienda Ospedaliera di Padova UOC Oncoematologia Pediatrica
    • Principal Investigator: Gianni Bisogno, MD
    • Contact: Gianni Bisogno, MD
    • Contact: Email: gianni.bisogno@unipd.it
  • Palermo, Italy, 90127
    • Recruiting
    • ARNAS P. O. "Civico e Benfratelli"
    • Contact: Paolo D'Angelo, MD; Phone Number: 4316 039 091666; Email: oncoematologia.ped@arnascivico.it
  • Pisa, Italy, 56126
    • Recruiting
    • Azienda Ospedaliero-Universitaria Pisana
    • Contact: Luca Coccoli, MD; Phone Number: 840 0039050992; Email: l.coccoli@ao-pisa.toscana.it
    • Principal Investigator: Luca Coccoli, MD
  • Roma, Italy
    • Not yet recruiting
    • Ospedale Pediatrico Bambin Gesu'
    • Contact: Giuseppe Maria Milano, MD; Phone Number: 111 06 68591; Email: giuseppemaria.milano@opbg.net
    • Principal Investigator: Giuseppe Maria Milano, MD
  • Roma, Italy
    • Recruiting
    • Istituti Fisioterapici Ospitalieri di Roma
    • Contact: Virginia Ferraresi, MD
    • Contact: Email: virginia.ferraresi@ifo.gov.it
    • Principal Investigator: Virginia Ferraresi, MD
  • Pordenone
    • Aviano, Pordenone, Italy, 33081
      • Recruiting
      • Centro di Riferimento Oncologico - Unit of Medical Oncology
      • Contact: Maurizio Mascarin, MD; Phone Number: 536 +390434659; Email: mascarin@cro.it
      • Principal Investigator: Maurizio Mascarin, MD
  • T
    • Trieste, T, Italy, 34137
      • Recruiting
      • IRCCS Materno Infantile Burlo Garofolo
      • Principal Investigator: Marco Rabusin, MD
      • Contact: Marco Rabusin, MD; Phone Number: 563 040.3785; Email: marco.rabusin@burlo.trieste.it
  • Torino
    • Candiolo, Torino, Italy, 10060
      • Recruiting
      • Sandra Aliberti
      • Principal Investigator: Giovanni Grignani, MD
      • Contact: Sandra Aliberti, MD; Phone Number: 3623 0039-011-993; Email: sandra.aliberti@ircc.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 40 years (Child, Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with localized high grade ostesarcoma of the extremities

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival (OS)	Time elapsed for the diagnosis to the death for any cause	at 5 years
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

Collaborators and Investigators

• Sponsor: Italian Sarcoma Group
• Collaborators: Associazione Italiana Ematologia Oncologia Pediatrica

Publications and helpful links

General Publications

• Rosen G, Caparros B, Huvos AG, Kosloff C, Nirenberg A, Cacavio A, Marcove RC, Lane JM, Mehta B, Urban C. Preoperative chemotherapy for osteogenic sarcoma: selection of postoperative adjuvant chemotherapy based on the response of the primary tumor to preoperative chemotherapy. Cancer. 1982 Mar 15;49(6):1221-30. doi: 10.1002/1097-0142(19820315)49:63.0.co;2-e.
• 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.
• Nardin A, Lefebvre ML, Labroquere K, Faure O, Abastado JP. Liposomal muramyl tripeptide phosphatidylethanolamine: Targeting and activating macrophages for adjuvant treatment of osteosarcoma. Curr Cancer Drug Targets. 2006 Mar;6(2):123-33. doi: 10.2174/156800906776056473.
• 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.
• Serra M, Pasello M, Manara MC, Scotlandi K, Ferrari S, Bertoni F, Mercuri M, Alvegard TA, Picci P, Bacci G, Smeland S. May P-glycoprotein status be used to stratify high-grade osteosarcoma patients? Results from the Italian/Scandinavian Sarcoma Group 1 treatment protocol. Int J Oncol. 2006 Dec;29(6):1459-68.
• 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.
• 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.
• Ottaviani G, Jaffe N. The epidemiology of osteosarcoma. Cancer Treat Res. 2009;152:3-13. doi: 10.1007/978-1-4419-0284-9_1.
• 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.
• Geller DS, Gorlick R. Osteosarcoma: a review of diagnosis, management, and treatment strategies. Clin Adv Hematol Oncol. 2010 Oct;8(10):705-18.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• Smeland S, Muller C, Alvegard TA, Wiklund T, Wiebe T, Bjork O, Stenwig AE, Willen H, Holmstrom T, Folleras G, Brosjo O, Kivioja A, Jonsson K, Monge O, Saeter G. Scandinavian Sarcoma Group Osteosarcoma Study SSG VIII: prognostic factors for outcome and the role of replacement salvage chemotherapy for poor histological responders. Eur J Cancer. 2003 Mar;39(4):488-94. doi: 10.1016/s0959-8049(02)00747-5.
• Le Deley MC, Guinebretiere JM, Gentet JC, Pacquement H, Pichon F, Marec-Berard P, Entz-Werle N, Schmitt C, Brugieres L, Vanel D, Dupouy N, Tabone MD, Kalifa C; Societe Francaise d'Oncologie Pediatrique (SFOP). SFOP OS94: a randomised trial comparing preoperative high-dose methotrexate plus doxorubicin to high-dose methotrexate plus etoposide and ifosfamide in osteosarcoma patients. Eur J Cancer. 2007 Mar;43(4):752-61. doi: 10.1016/j.ejca.2006.10.023. Epub 2007 Jan 30.
• Piperno-Neumann S, Le Deley MC, Redini F, Pacquement H, Marec-Berard P, Petit P, Brisse H, Lervat C, Gentet JC, Entz-Werle N, Italiano A, Corradini N, Bompas E, Penel N, Tabone MD, Gomez-Brouchet A, Guinebretiere JM, Mascard E, Gouin F, Chevance A, Bonnet N, Blay JY, Brugieres L; Sarcoma Group of UNICANCER; French Society of Pediatric Oncology (SFCE); French Sarcoma Group (GSF-GETO). Zoledronate in combination with chemotherapy and surgery to treat osteosarcoma (OS2006): a randomised, multicentre, open-label, phase 3 trial. Lancet Oncol. 2016 Aug;17(8):1070-1080. doi: 10.1016/S1470-2045(16)30096-1. Epub 2016 Jun 17.
• 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.
• 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.
• Bishop MW, Chang YC, Krailo MD, Meyers PA, Provisor AJ, Schwartz CL, Marina NM, Teot LA, Gebhardt MC, Gorlick R, Janeway KA, Chou AJ. Assessing the Prognostic Significance of Histologic Response in Osteosarcoma: A Comparison of Outcomes on CCG-782 and INT0133-A Report From the Children's Oncology Group Bone Tumor Committee. Pediatr Blood Cancer. 2016 Oct;63(10):1737-43. doi: 10.1002/pbc.26034. Epub 2016 Apr 29.
• Harrison DJ, Geller DS, Gill JD, Lewis VO, Gorlick R. Current and future therapeutic approaches for osteosarcoma. Expert Rev Anticancer Ther. 2018 Jan;18(1):39-50. doi: 10.1080/14737140.2018.1413939. Epub 2017 Dec 14.
• Kleinerman ES, Erickson KL, Schroit AJ, Fogler WE, Fidler IJ. Activation of tumoricidal properties in human blood monocytes by liposomes containing lipophilic muramyl tripeptide. Cancer Res. 1983 May;43(5):2010-4.
• Anderson P. Liposomal muramyl tripeptide phosphatidyl ethanolamine: ifosfamide-containing chemotherapy in osteosarcoma. Future Oncol. 2006 Jun;2(3):333-43. doi: 10.2217/14796694.2.3.333.
• 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.
• 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.
• Ando K, Mori K, Corradini N, Redini F, Heymann D. Mifamurtide for the treatment of nonmetastatic osteosarcoma. Expert Opin Pharmacother. 2011 Feb;12(2):285-92. doi: 10.1517/14656566.2011.543129.
• Marina N, Bielack S, Whelan J, Smeland S, Krailo M, Sydes MR, Butterfass-Bahloul T, Calaminus G, Bernstein M. International collaboration is feasible in trials for rare conditions: the EURAMOS experience. Cancer Treat Res. 2009;152:339-53. doi: 10.1007/978-1-4419-0284-9_18.
• Bishop MW, Janeway KA, Gorlick R. Future directions in the treatment of osteosarcoma. Curr Opin Pediatr. 2016 Feb;28(1):26-33. doi: 10.1097/MOP.0000000000000298.
• 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.
• Serra M, Scotlandi K, Reverter-Branchat G, Ferrari S, Manara MC, Benini S, Incaprera M, Bertoni F, Mercuri M, Briccoli A, Bacci G, Picci P. Value of P-glycoprotein and clinicopathologic factors as the basis for new treatment strategies in high-grade osteosarcoma of the extremities. J Clin Oncol. 2003 Feb 1;21(3):536-42. doi: 10.1200/JCO.2003.03.144.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 30, 2021
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 30, 2026

Study Registration Dates

• First Submitted: May 12, 2021
• First Submitted That Met QC Criteria: May 12, 2021
• First Posted (Actual): May 18, 2021

Study Record Updates

• Last Update Posted (Actual): March 27, 2026
• Last Update Submitted That Met QC Criteria: March 24, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Osteosarcoma
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Sarcoma; Neoplasms, Connective and Soft Tissue; Neoplasms, Bone Tissue; Neoplasms, Connective Tissue; Osteosarcoma; Therapeutics; Radiotherapy; Surgical Procedures, Operative
• Other Study ID Numbers: AIEOP/ISGOS2 Oss

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No plan sharing

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No