局限性骨肉瘤的观察性研究 (ISG Os2Oss)
2026年9月1日 更新者:Italian Sarcoma Group
局限性骨肉瘤患者治疗的多中心观察研究
观察性前瞻性试验旨在收集根据 AIEOP/意大利肉瘤组 (ISG) OS 2021 治疗的局部骨肉瘤 (OS) 患者的人口统计学、临床、手术、病理和分子特征以及治疗
研究概览
详细说明
骨肉瘤是儿童和青少年最常见的原发性恶性骨肿瘤,被认为是一种罕见病。
OS 的总发病率为每年 0.2-3 / 100,000 居民,按年龄呈双峰分布,第一个高峰出现在青春期。
目前,局部 OS 的治疗策略包括基于 3 种药物的新辅助化疗疗程:阿霉素(ADM)、顺铂(CDP)和高剂量甲氨蝶呤(HDMTX),然后手术切除原发肿瘤和随后的辅助化疗。
MAP(甲氨蝶呤、阿霉素、顺铂)方案,联合或不联合异环磷酰胺 (IFO) 和依托泊苷 (ETO),被认为是治疗局部骨肉瘤的“金标准”。
鉴于该疾病的罕见性,根据局部 OS AIEOP/ISG OS 治疗建议,前瞻性收集 AIEOP 和 ISG 中心网络治疗的患者的诊断、化疗和手术治疗以及结果的信息被认为是适当的2021.
这项研究将一直持续到下一个旨在治疗高级别、非转移性 OS 的介入前瞻性方案。
研究类型
观察性的
注册 (估计的)
120
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习联系方式
- 姓名:Franca Fagioli, MD/Prof
- 电话号码:151 0039-0113135
- 邮箱:franca.fagioli@unito.it
研究联系人备份
- 姓名:Sebastian D Asaftei, MD
- 电话号码:998 0039-011 3135
- 邮箱:sebastiandorin.asaftei@unito.it
学习地点
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Bari、意大利、70124
- 招聘中
- Azienda Ospedaliero Universitaria Consorziale Policlinico - Bari
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接触:
- Francesco De Leonardis, MD
- 电话号码:137 00390805592
- 邮箱:francesco.deleonardis@policlinico.ba.it
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首席研究员:
- Francesco De Leonardis, MD
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Bologna、意大利、40136
- 招聘中
- IRCCS Istituto Ortopedico Rizzoli
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接触:
- Michela Pierini, PhD
- 电话号码:668 +390516366
- 邮箱:michela.pierini@ior.it
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首席研究员:
- Toni Ibrahim, MD
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接触:
- Toni Ibrahim, MD
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Bologna、意大利、40138
- 招聘中
- A.O. Universitaria Policlinico S. Orsola Malpighi di Bologna
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接触:
- Arcangelo Prete, MD
- 电话号码:111 +390516363
- 邮箱:tmoped@aosp.bo.it
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首席研究员:
- Arcangelo Prete, MD
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Catania、意大利、95123
- 招聘中
- AUO Policnico G. Rodolico San Marco
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接触:
- Andrea Di Cataldo, MD
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接触:
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Florence、意大利、50139
- 招聘中
- A.O. Universitaria Meyer
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接触:
- Angela Tamburini, MD
- 电话号码:621 +3905556
- 邮箱:a.tamburini@meyer.it
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首席研究员:
- Angela Tamburini, MD
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Genova、意大利
- 招聘中
- Istituto Giannina Gaslini
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首席研究员:
- Carla Manzitti, MD
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接触:
- Carla Manzitti, MD
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Milan、意大利
- 招聘中
- Fondazione IRCCS Istituto Nazionale dei Tumori
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首席研究员:
- Rossella Bertulli, MD
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接触:
- Rossella Bertulli, MD
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Milan、意大利
- 招聘中
- Fondazione IRCCS INT Milano SC Pediatria Oncologica
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接触:
- Cristina Meazza, MD
- 电话号码:+390223903
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首席研究员:
- Cristina Meazza, MD
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Padova、意大利
- 招聘中
- Azienda Ospedaliera di Padova UOC Oncoematologia Pediatrica
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首席研究员:
- Gianni Bisogno, MD
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接触:
- Gianni Bisogno, MD
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接触:
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Palermo、意大利、90127
- 招聘中
- ARNAS P. O. "Civico e Benfratelli"
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接触:
- Paolo D'Angelo, MD
- 电话号码:4316 039 091666
- 邮箱:oncoematologia.ped@arnascivico.it
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Pisa、意大利、56126
- 招聘中
- Azienda Ospedaliero-Universitaria Pisana
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接触:
- Luca Coccoli, MD
- 电话号码:840 0039050992
- 邮箱:l.coccoli@ao-pisa.toscana.it
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首席研究员:
- Luca Coccoli, MD
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Roma、意大利
- 尚未招聘
- Ospedale Pediatrico Bambin Gesu'
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接触:
- Giuseppe Maria Milano, MD
- 电话号码:111 06 68591
- 邮箱:giuseppemaria.milano@opbg.net
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首席研究员:
- Giuseppe Maria Milano, MD
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Roma、意大利
- 招聘中
- Istituti Fisioterapici Ospitalieri di Roma
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接触:
- Virginia Ferraresi, MD
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首席研究员:
- Virginia Ferraresi, MD
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Pordenone
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Aviano、Pordenone、意大利、33081
- 招聘中
- Centro di Riferimento Oncologico - Unit of Medical Oncology
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接触:
- Maurizio Mascarin, MD
- 电话号码:536 +390434659
- 邮箱:mascarin@cro.it
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首席研究员:
- Maurizio Mascarin, MD
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T
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Trieste、T、意大利、34137
- 招聘中
- IRCCS materno infantile Burlo Garofolo
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首席研究员:
- Marco Rabusin, MD
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接触:
- Marco Rabusin, MD
- 电话号码:563 040.3785
- 邮箱:marco.rabusin@burlo.trieste.it
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Torino
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Candiolo、Torino、意大利、10060
- 招聘中
- Sandra Aliberti
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首席研究员:
- Giovanni Grignani, MD
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接触:
- Sandra Aliberti, MD
- 电话号码:3623 0039-011-993
- 邮箱:sandra.aliberti@ircc.it
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参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
不超过 40年 (孩子、成人)
接受健康志愿者
不
取样方法
非概率样本
研究人群
四肢局限性高级别骨肉瘤患者
描述
纳入标准:
- 四肢高级OS的诊断
- 诊断时年龄 ≤ 40 岁
- 局部疾病(允许跳跃转移)
- 根据 AIEOP/ISG OS 2021 推荐的适当器官功能
- 已书面同意参加研究的患者或未成年人的父母或监护人
排除标准:
- 转移的存在
- 骨膜 OS、骨旁 OS 或继发性 OS 的诊断
- 任何不允许使用 AIEOP/ISG OS 2021 推荐治疗的医疗状况
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 观测模型:队列
- 时间观点:预期
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
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局限性骨肉瘤
该队列包括受局部骨肉瘤影响的患者,转诊至参与机构。
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该观察性研究根据 AIEOP/ISG OS 2021 收集患者接受的所有治疗,因此包括药物/生物/手术/放射治疗和任何其他适用的治疗
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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5 年无事件生存 (EFS)
大体时间:5年
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任何事件的发生(事件定义为疾病复发、因疾病或任何其他原因死亡)
|
5年
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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总生存期(OS)
大体时间:5岁
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从诊断到全因死亡的时间
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5岁
|
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与治疗相关的不良事件
大体时间:每 3 周一次(第 3 周、第 6 周、第 9 周、第 12 周...),最多 36 个月
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根据不良事件通用术语标准 5.0 版评估的发生与治疗相关的不良事件的参与者人数
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每 3 周一次(第 3 周、第 6 周、第 9 周、第 12 周...),最多 36 个月
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
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- 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.
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研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2021年7月30日
初级完成 (估计的)
2026年9月30日
研究完成 (估计的)
2026年12月30日
研究注册日期
首次提交
2021年5月12日
首先提交符合 QC 标准的
2021年5月12日
首次发布 (实际的)
2021年5月18日
研究记录更新
最后更新发布 (实际的)
2026年9月2日
上次提交的符合 QC 标准的更新
2026年9月1日
最后验证
2026年9月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.