Dose Escalated Proton Beam Therapy or Photon Therapy for Esophageal Cancer (ES01)
2018年12月19日 更新者：University of Florida
A Phase II Trial of Dose Escalated Proton Beam Therapy or Photon Therapy for Resectable and Unresectable Esophageal Cancer
This study will evaluate if proton beam therapy as part of chemoradiation results in a decrease in diffusion lung capacity of carbon monoxide (DLCO) compared to photon radiation therapy for esophageal carcinoma.
A secondary objective is to determine effects on cardiac function, quality of life, and compare acute and late toxicities.
研究概览
详细说明
Radiation Modality: Proton radiotherapy will be offered to all patients that meet trial eligibility. If patients decline proton radiotherapy or are otherwise unable to receive proton therapy they will be included in x-ray cohort (group 2).
Chemotherapy will be delivered at the discretion of the treating Medical Oncologist. Weekly carboplatin and paclitaxel at standard doses is preferred. It is recommended that the weekly chemotherapy regimen be continued throughout the course of radiotherapy. Chemotherapy should begin within 48 hours of beginning radiotherapy.
研究类型
介入性
阶段
- 阶段2
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。
学习地点
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Florida
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Jacksonville、Florida、美国、32206
- University of Florida Proton Therapy Institute
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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
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Patient must be at least 18 years at the time of consent.
- Pathologically confirmed esophageal adenocarcinoma or squamous cell. carcinoma of the thoracic esophagus or esophagogastric junction.
- Patient's preliminary cancer stage, according to the AJCC 7th edition staging, must be cT1b-T4, N0-N3.
Exclusion Criteria:
- Patients with cervical esophageal carcinoma.
- Prior radiotherapy with fields overlapping the current esophageal cancer.
- Patients with cT1a disease.
- Patients with evidence of tracheoesophageal fistula must undergo bronchoscopy to exclude fistula.
- Patients with distant metastatic disease.
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
- 主要用途：治疗
- 分配：非随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：Proton
Proton beam therapy of 59.4 Gy in 1.8 Gy fractions (50.4 Gy if unable to meet cardiac/lung- organs at risk (OAR) constraints) plus concurrent standard chemotherapy
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59.4 Gy (RBE) in 1.8 Gy per fraction plus weekly chemotherapy at standard doses
其他名称：
Concurrent weekly chemotherapy at standard doses
其他名称：
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有源比较器：Photon
Photon Radiation therapy of 59.4 Gy in 1.8Gy fractions ( 50.4 Gy if unable to meet cardiac/lung- organs at risk (OAR) constraints) plus concurrent standard chemotherapy
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Concurrent weekly chemotherapy at standard doses
其他名称：
59.4 Gy (RBE) in 1.8 Gy per fraction plus weekly chemotherapy at standard doses
其他名称：
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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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Compare the rate of a clinically significant reduction of DLCO (defined as a decrease of ≥ 10% from baseline) between protons and photons after preoperative or definitive chemoradiation
大体时间：Approximately 12 months after radiation therapy
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Participants with a clinically significant reduction of DLCO approximately 12 months after radiation therapy
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Approximately 12 months after radiation therapy
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Compare quality of life
大体时间：Approximately 12 months after radiation therapy
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Participants quality of life results using EORTC Quality of Life Questionnaire - Oesophageal Cancer Module (OES-18) and EORTC QLQ C-30 conjointly approximately 12 months after radiation therapy
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Approximately 12 months after radiation therapy
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Compare outcomes for local control
大体时间：Approximately 12 months after radiation therapy
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Number of participants with local control for proton and photon radiation and concurrent chemotherapy as part of definitive therapy or trimodality therapy approximately 12 months after radiation therapy
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Approximately 12 months after radiation therapy
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Compare outcomes for progression free survival
大体时间：Approximately 12 months after radiation therapy
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Number of participants with progression free survival for proton and photon radiation and concurrent chemotherapy as part of definitive therapy or trimodality therapy approximately 12 months after radiation therapy
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Approximately 12 months after radiation therapy
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Compare overall survival rates
大体时间：Approximately 12 months after radiation therapy
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Number of participants with overall survival rates for proton and photon radiation and concurrent chemotherapy as part of definitive therapy or trimodality therapy approximately 12 months after radiation therapy
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Approximately 12 months after radiation therapy
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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。
调查人员
- 首席研究员：Michael Rutenberg, MD, PhD、UF Health Proton Therapy Institute
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
- Siegel RL, Miller KD, Jemal A. Cancer statistics, 2016. CA Cancer J Clin. 2016 Jan-Feb;66(1):7-30. doi: 10.3322/caac.21332. Epub 2016 Jan 7.
- van Hagen P, Hulshof MC, van Lanschot JJ, Steyerberg EW, van Berge Henegouwen MI, Wijnhoven BP, Richel DJ, Nieuwenhuijzen GA, Hospers GA, Bonenkamp JJ, Cuesta MA, Blaisse RJ, Busch OR, ten Kate FJ, Creemers GJ, Punt CJ, Plukker JT, Verheul HM, Spillenaar Bilgen EJ, van Dekken H, van der Sangen MJ, Rozema T, Biermann K, Beukema JC, Piet AH, van Rij CM, Reinders JG, Tilanus HW, van der Gaast A; CROSS Group. Preoperative chemoradiotherapy for esophageal or junctional cancer. N Engl J Med. 2012 May 31;366(22):2074-84. doi: 10.1056/NEJMoa1112088.
- Donohoe CL, McGillycuddy E, Reynolds JV. Long-term health-related quality of life for disease-free esophageal cancer patients. World J Surg. 2011 Aug;35(8):1853-60. doi: 10.1007/s00268-011-1123-6.
- Lund M, Alexandersson von Dobeln G, Nilsson M, Winter R, Lundell L, Tsai JA, Kalman S. Effects on heart function of neoadjuvant chemotherapy and chemoradiotherapy in patients with cancer in the esophagus or gastroesophageal junction - a prospective cohort pilot study within a randomized clinical trial. Radiat Oncol. 2015 Jan 13;10:16. doi: 10.1186/s13014-014-0310-7.
- Tepper J, Krasna MJ, Niedzwiecki D, Hollis D, Reed CE, Goldberg R, Kiel K, Willett C, Sugarbaker D, Mayer R. Phase III trial of trimodality therapy with cisplatin, fluorouracil, radiotherapy, and surgery compared with surgery alone for esophageal cancer: CALGB 9781. J Clin Oncol. 2008 Mar 1;26(7):1086-92. doi: 10.1200/JCO.2007.12.9593.
- Bedenne L, Michel P, Bouche O, Milan C, Mariette C, Conroy T, Pezet D, Roullet B, Seitz JF, Herr JP, Paillot B, Arveux P, Bonnetain F, Binquet C. Chemoradiation followed by surgery compared with chemoradiation alone in squamous cancer of the esophagus: FFCD 9102. J Clin Oncol. 2007 Apr 1;25(10):1160-8. doi: 10.1200/JCO.2005.04.7118.
- Donahue JM, Nichols FC, Li Z, Schomas DA, Allen MS, Cassivi SD, Jatoi A, Miller RC, Wigle DA, Shen KR, Deschamps C. Complete pathologic response after neoadjuvant chemoradiotherapy for esophageal cancer is associated with enhanced survival. Ann Thorac Surg. 2009 Feb;87(2):392-8; discussion 398-9. doi: 10.1016/j.athoracsur.2008.11.001.
- Stahl M, Stuschke M, Lehmann N, Meyer HJ, Walz MK, Seeber S, Klump B, Budach W, Teichmann R, Schmitt M, Schmitt G, Franke C, Wilke H. Chemoradiation with and without surgery in patients with locally advanced squamous cell carcinoma of the esophagus. J Clin Oncol. 2005 Apr 1;23(10):2310-7. doi: 10.1200/JCO.2005.00.034. Erratum In: J Clin Oncol. 2006 Jan 20;24(3):531.
- Ferguson MK, Celauro AD, Prachand V. Prediction of major pulmonary complications after esophagectomy. Ann Thorac Surg. 2011 May;91(5):1494-1500; discussion 1500-1. doi: 10.1016/j.athoracsur.2010.12.036.
- Ferguson MK, Durkin AE. Preoperative prediction of the risk of pulmonary complications after esophagectomy for cancer. J Thorac Cardiovasc Surg. 2002 Apr;123(4):661-9. doi: 10.1067/mtc.2002.120350.
- Walsh TN, Noonan N, Hollywood D, Kelly A, Keeling N, Hennessy TP. A comparison of multimodal therapy and surgery for esophageal adenocarcinoma. N Engl J Med. 1996 Aug 15;335(7):462-7. doi: 10.1056/NEJM199608153350702. Erratum In: N Engl J Med 1999 Jul 29;341(5):384.
- Gergel TJ, Leichman L, Nava HR, Blumenson LE, Loewen GM, Gibbs JE, Khushalani NI, Leichman CG, Bodnar LM, Douglass HO, Smith JL, Kuettel MR, Proulx GM. Effect of concurrent radiation therapy and chemotherapy on pulmonary function in patients with esophageal cancer: dose-volume histogram analysis. Cancer J. 2002 Nov-Dec;8(6):451-60. doi: 10.1097/00130404-200211000-00009.
- von Dobeln GA, Nilsson M, Adell G, Johnsen G, Hatlevoll I, Tsai J, Lundell L, Lund M, Lind P. Pulmonary function and cardiac stress test after multimodality treatment of esophageal cancer. Pract Radiat Oncol. 2016 May-Jun;6(3):e53-e59. doi: 10.1016/j.prro.2015.10.015. Epub 2015 Nov 10.
- Lee HK, Vaporciyan AA, Cox JD, Tucker SL, Putnam JB Jr, Ajani JA, Liao Z, Swisher SG, Roth JA, Smythe WR, Walsh GL, Mohan R, Liu HH, Mooring D, Komaki R. Postoperative pulmonary complications after preoperative chemoradiation for esophageal carcinoma: correlation with pulmonary dose-volume histogram parameters. Int J Radiat Oncol Biol Phys. 2003 Dec 1;57(5):1317-22. doi: 10.1016/s0360-3016(03)01373-7.
- Wang J, Wei C, Tucker SL, Myles B, Palmer M, Hofstetter WL, Swisher SG, Ajani JA, Cox JD, Komaki R, Liao Z, Lin SH. Predictors of postoperative complications after trimodality therapy for esophageal cancer. Int J Radiat Oncol Biol Phys. 2013 Aug 1;86(5):885-91. doi: 10.1016/j.ijrobp.2013.04.006.
- De Jaeger K, Seppenwoolde Y, Boersma LJ, Muller SH, Baas P, Belderbos JS, Lebesque JV. Pulmonary function following high-dose radiotherapy of non-small-cell lung cancer. Int J Radiat Oncol Biol Phys. 2003 Apr 1;55(5):1331-40. doi: 10.1016/s0360-3016(02)04389-4.
- Marks LB, Fan M, Clough R, Munley M, Bentel G, Coleman RE, Jaszczak R, Hollis D, Anscher M. Radiation-induced pulmonary injury: symptomatic versus subclinical endpoints. Int J Radiat Biol. 2000 Apr;76(4):469-75. doi: 10.1080/095530000138466.
- Lopez Guerra JL, Gomez DR, Zhuang Y, Levy LB, Eapen G, Liu H, Mohan R, Komaki R, Cox JD, Liao Z. Changes in pulmonary function after three-dimensional conformal radiotherapy, intensity-modulated radiotherapy, or proton beam therapy for non-small-cell lung cancer. Int J Radiat Oncol Biol Phys. 2012 Jul 15;83(4):e537-43. doi: 10.1016/j.ijrobp.2012.01.019. Epub 2012 Mar 13.
- Miller KL, Zhou SM, Barrier RC Jr, Shafman T, Folz RJ, Clough RW, Marks LB. Long-term changes in pulmonary function tests after definitive radiotherapy for lung cancer. Int J Radiat Oncol Biol Phys. 2003 Jul 1;56(3):611-5. doi: 10.1016/s0360-3016(03)00182-2.
- Enache I, Noel G, Jeung MY, Meyer N, Oswald-Mammosser M, Pistea C, Jung GM, Mennecier B, Quoix E, Charloux A. Impact of 3D conformal radiotherapy on lung function of patients with lung cancer: a prospective study. Respiration. 2013;86(2):100-8. doi: 10.1159/000342371. Epub 2012 Nov 13.
- Borst GR, De Jaeger K, Belderbos JS, Burgers SA, Lebesque JV. Pulmonary function changes after radiotherapy in non-small-cell lung cancer patients with long-term disease-free survival. Int J Radiat Oncol Biol Phys. 2005 Jul 1;62(3):639-44. doi: 10.1016/j.ijrobp.2004.11.029.
- Lin FC, Durkin AE, Ferguson MK. Induction therapy does not increase surgical morbidity after esophagectomy for cancer. Ann Thorac Surg. 2004 Nov;78(5):1783-9. doi: 10.1016/j.athoracsur.2004.04.081.
- Cerfolio RJ, Talati A, Bryant AS. Changes in pulmonary function tests after neoadjuvant therapy predict postoperative complications. Ann Thorac Surg. 2009 Sep;88(3):930-5; discussion 935-6. doi: 10.1016/j.athoracsur.2009.06.013.
- Gill PG, Denham JW, Jamieson GG, Devitt PG, Yeoh E, Olweny C. Patterns of treatment failure and prognostic factors associated with the treatment of esophageal carcinoma with chemotherapy and radiotherapy either as sole treatment or followed by surgery. J Clin Oncol. 1992 Jul;10(7):1037-43. doi: 10.1200/JCO.1992.10.7.1037. Erratum In: J Clin Oncol 1992 Nov;10(11):1822.
- Chirieac LR, Swisher SG, Ajani JA, Komaki RR, Correa AM, Morris JS, Roth JA, Rashid A, Hamilton SR, Wu TT. Posttherapy pathologic stage predicts survival in patients with esophageal carcinoma receiving preoperative chemoradiation. Cancer. 2005 Apr 1;103(7):1347-55. doi: 10.1002/cncr.20916.
- Meredith KL, Weber JM, Turaga KK, Siegel EM, McLoughlin J, Hoffe S, Marcovalerio M, Shah N, Kelley S, Karl R. Pathologic response after neoadjuvant therapy is the major determinant of survival in patients with esophageal cancer. Ann Surg Oncol. 2010 Apr;17(4):1159-67. doi: 10.1245/s10434-009-0862-1. Epub 2010 Feb 6.
- Bosset JF, Gignoux M, Triboulet JP, Tiret E, Mantion G, Elias D, Lozach P, Ollier JC, Pavy JJ, Mercier M, Sahmoud T. Chemoradiotherapy followed by surgery compared with surgery alone in squamous-cell cancer of the esophagus. N Engl J Med. 1997 Jul 17;337(3):161-7. doi: 10.1056/NEJM199707173370304.
- Yoon DH, Jang G, Kim JH, Kim YH, Kim JY, Kim HR, Jung HY, Lee GH, Song HY, Cho KJ, Ryu JS, Kim SB. Randomized phase 2 trial of S1 and oxaliplatin-based chemoradiotherapy with or without induction chemotherapy for esophageal cancer. Int J Radiat Oncol Biol Phys. 2015 Mar 1;91(3):489-96. doi: 10.1016/j.ijrobp.2014.11.019. Epub 2015 Jan 30.
- Spigel DR, Greco FA, Meluch AA, Lane CM, Farley C, Gray JR, Clark BL, Burris HA 3rd, Hainsworth JD. Phase I/II trial of preoperative oxaliplatin, docetaxel, and capecitabine with concurrent radiation therapy in localized carcinoma of the esophagus or gastroesophageal junction. J Clin Oncol. 2010 May 1;28(13):2213-9. doi: 10.1200/JCO.2009.24.8773. Epub 2010 Mar 29.
- Ajani JA, Xiao L, Roth JA, Hofstetter WL, Walsh G, Komaki R, Liao Z, Rice DC, Vaporciyan AA, Maru DM, Lee JH, Bhutani MS, Eid A, Yao JC, Phan AP, Halpin A, Suzuki A, Taketa T, Thall PF, Swisher SG. A phase II randomized trial of induction chemotherapy versus no induction chemotherapy followed by preoperative chemoradiation in patients with esophageal cancer. Ann Oncol. 2013 Nov;24(11):2844-9. doi: 10.1093/annonc/mdt339. Epub 2013 Aug 23.
- Venkat P, Shridhar R, Naghavi A, et al. Pathologic Complete Response and Dose Escalation with Preoperative Dose Painting IMRT Chemoradiation in Esophageal Cancer. IJROBP. 2015; 93:S219-220
- Makishima H, Ishikawa H, Terunuma T, Hashimoto T, Yamanashi K, Sekiguchi T, Mizumoto M, Okumura T, Sakae T, Sakurai H. Comparison of adverse effects of proton and X-ray chemoradiotherapy for esophageal cancer using an adaptive dose-volume histogram analysis. J Radiat Res. 2015 May;56(3):568-76. doi: 10.1093/jrr/rrv001. Epub 2015 Mar 9.
- Wang J, Palmer M, Bilton SD, et al. Comparing Proton Beam to Intensity Modulated Radiation Therapy Planning in Esophageal Cancer. Int J Particle Ther. 2015;1:866-877.
- Wang SL, Liao Z, Vaporciyan AA, Tucker SL, Liu H, Wei X, Swisher S, Ajani JA, Cox JD, Komaki R. Investigation of clinical and dosimetric factors associated with postoperative pulmonary complications in esophageal cancer patients treated with concurrent chemoradiotherapy followed by surgery. Int J Radiat Oncol Biol Phys. 2006 Mar 1;64(3):692-9. doi: 10.1016/j.ijrobp.2005.08.002. Epub 2005 Oct 19.
- Wei X, Liu HH, Tucker SL, Wang S, Mohan R, Cox JD, Komaki R, Liao Z. Risk factors for pericardial effusion in inoperable esophageal cancer patients treated with definitive chemoradiation therapy. Int J Radiat Oncol Biol Phys. 2008 Mar 1;70(3):707-14. doi: 10.1016/j.ijrobp.2007.10.056. Epub 2008 Jan 11.
- Blazeby JM, Conroy T, Hammerlid E, Fayers P, Sezer O, Koller M, Arraras J, Bottomley A, Vickery CW, Etienne PL, Alderson D; European Organisation for Research and Treatement of Cancer Gastrointestinal and Quality of Life Groups. Clinical and psychometric validation of an EORTC questionnaire module, the EORTC QLQ-OES18, to assess quality of life in patients with oesophageal cancer. Eur J Cancer. 2003 Jul;39(10):1384-94. doi: 10.1016/s0959-8049(03)00270-3.
- Derogar M, Lagergren P. Health-related quality of life among 5-year survivors of esophageal cancer surgery: a prospective population-based study. J Clin Oncol. 2012 Feb 1;30(4):413-8. doi: 10.1200/JCO.2011.38.9791. Epub 2012 Jan 3.
- Hurmuzlu M, Aarstad HJ, Aarstad AK, Hjermstad MJ, Viste A. Health-related quality of life in long-term survivors after high-dose chemoradiotherapy followed by surgery in esophageal cancer. Dis Esophagus. 2011 Jan;24(1):39-47. doi: 10.1111/j.1442-2050.2010.01104.x. Epub 2010 Sep 2.
- Kachnic LA, Winter K, Wasserman T, Kelsen D, Ginsberg R, Pisansky TM, Martenson J, Komaki R, Okawara G, Rosenthal SA, Willett CG, Minsky BD. Longitudinal Quality-of-Life Analysis of RTOG 94-05 (Int 0123):A Phase III Trial of Definitive Chemoradiotherapy for Esophageal Cancer. Gastrointest Cancer Res. 2011 Mar;4(2):45-52.
- Warren S, Partridge M, Carrington R, Hurt C, Crosby T, Hawkins MA. Radiobiological determination of dose escalation and normal tissue toxicity in definitive chemoradiation therapy for esophageal cancer. Int J Radiat Oncol Biol Phys. 2014 Oct 1;90(2):423-9. doi: 10.1016/j.ijrobp.2014.06.028.
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)
2017年10月30日
初级完成 (实际的)
2018年12月11日
研究完成 (实际的)
2018年12月11日
研究注册日期
首次提交
2017年7月21日
首先提交符合 QC 标准的
2017年7月26日
首次发布 (实际的)
2017年7月31日
研究记录更新
最后更新发布 (实际的)
2018年12月21日
上次提交的符合 QC 标准的更新
2018年12月19日
最后验证
2018年12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.
Proton Beam Therapy的临床试验
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Stephan Grupp MD PhDBeam Therapeutics Inc.招聘中
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Beam Therapeutics Inc.招聘中
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Lymphoma Study Association完全的
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University of Applied Sciences and Arts of Southern...Vrije Universiteit Brussel; Universiteit Antwerpen; THIM - die internationale Hochschule für Physiotherapie完全的