Clinical trial NCT02986516 - References

Chordoma — Sacral Chordoma: Surgery Versus Definitive Radiation Therapy in Primary Localized Disease

Citation(s)

•   Asavamongkolkul A, Waikakul S
  Wide resection of sacral chordoma via a posterior approach. Int Orthop. 2012 Mar;36(3):607-12. doi: 10.1007/s00264-011-1381-9. Epub 2011 Oct 29.
•   Brien EW, Mirra JM, Ippolito V
  Chondroblastoma arising from a nonepiphyseal site. Skeletal Radiol. 1995 Apr;24(3):220-2. doi: 10.1007/BF00228930.
•   Chen KW, Yang HL, Kandimalla Y, Liu JY, Wang GL
  Review of current treatment of sacral chordoma. Orthop Surg. 2009 Aug;1(3):238-44. doi: 10.1111/j.1757-7861.2009.00027.x.
•   Chen YL, Liebsch N, Kobayashi W, Goldberg S, Kirsch D, Calkins G, Childs S, Schwab J, Hornicek F, DeLaney T
  Definitive high-dose photon/proton radiotherapy for unresected mobile spine and sacral chordomas. Spine (Phila Pa 1976). 2013 Jul 1;38(15):E930-6. doi: 10.1097/BRS.0b013e318296e7d7.
•   Clarke MJ, Dasenbrock H, Bydon A, Sciubba DM, McGirt MJ, Hsieh PC, Yassari R, Gokaslan ZL, Wolinsky JP
  Posterior-only approach for en bloc sacrectomy: clinical outcomes in 36 consecutive patients. Neurosurgery. 2012 Aug;71(2):357-64; discussion 364. doi: 10.1227/NEU.0b013e31825d01d4.
•   DeLaney TF, Liebsch NJ, Pedlow FX, Adams J, Dean S, Yeap BY, McManus P, Rosenberg AE, Nielsen GP, Harmon DC, Spiro IJ, Raskin KA, Suit HD, Yoon SS, Hornicek FJ
  Phase II study of high-dose photon/proton radiotherapy in the management of spine sarcomas. Int J Radiat Oncol Biol Phys. 2009 Jul 1;74(3):732-9. doi: 10.1016/j.ijrobp.2008.08.058. Epub 2008 Dec 25.
•   DeLaney TF, Liebsch NJ, Pedlow FX, Adams J, Weyman EA, Yeap BY, Depauw N, Nielsen GP, Harmon DC, Yoon SS, Chen YL, Schwab JH, Hornicek FJ
  Long-term results of Phase II study of high dose photon/proton radiotherapy in the management of spine chordomas, chondrosarcomas, and other sarcomas. J Surg Oncol. 2014 Aug;110(2):115-22. doi: 10.1002/jso.23617. Epub 2014 Apr 19.
•   Doita M, Harada T, Iguchi T, Sumi M, Sha H, Yoshiya S, Kurosaka M
  Total sacrectomy and reconstruction for sacral tumors. Spine (Phila Pa 1976). 2003 Aug 1;28(15):E296-301. doi: 10.1097/01.BRS.0000083230.12704.E3.
•   Dubory A, Missenard G, Lambert B, Court C
  "En bloc" resection of sacral chordomas by combined anterior and posterior surgical approach: a monocentric retrospective review about 29 cases. Eur Spine J. 2014 Sep;23(9):1940-8. doi: 10.1007/s00586-014-3196-z. Epub 2014 Jan 28.
•   Dutton RV, Singleton EB
  Tuberous sclerosis: a case report with aortic aneurysm and unusual rib changes. Pediatr Radiol. 1975 Jun 13;3(3):184-6. doi: 10.1007/BF01006909.
•   Fossati P, Molinelli S, Matsufuji N, Ciocca M, Mirandola A, Mairani A, Mizoe J, Hasegawa A, Imai R, Kamada T, Orecchia R, Tsujii H
  Dose prescription in carbon ion radiotherapy: a planning study to compare NIRS and LEM approaches with a clinically-oriented strategy. Phys Med Biol. 2012 Nov 21;57(22):7543-54. doi: 10.1088/0031-9155/57/22/7543. Epub 2012 Oct 26.
•   Gennari L, Azzarelli A, Quagliuolo V
  A posterior approach for the excision of sacral chordoma. J Bone Joint Surg Br. 1987 Aug;69(4):565-8. doi: 10.1302/0301-620X.69B4.3611160.
•   Henderson FC, McCool K, Seigle J, Jean W, Harter W, Gagnon GJ
  Treatment of chordomas with CyberKnife: georgetown university experience and treatment recommendations. Neurosurgery. 2009 Feb;64(2 Suppl):A44-53. doi: 10.1227/01.NEU.0000341166.09107.47.
•   Imai R, Kamada T, Sugahara S, Tsuji H, Tsujii H
  Carbon ion radiotherapy for sacral chordoma. Br J Radiol. 2011 Dec;84 Spec No 1(Spec Iss 1):S48-54. doi: 10.1259/bjr/13783281. Epub 2011 Mar 22.
•   Kayani B, Hanna SA, Sewell MD, Saifuddin A, Molloy S, Briggs TW
  A review of the surgical management of sacral chordoma. Eur J Surg Oncol. 2014 Nov;40(11):1412-20. doi: 10.1016/j.ejso.2014.04.008. Epub 2014 Apr 25.
•   Kelley MJ, Korczak JF, Sheridan E, Yang X, Goldstein AM, Parry DM
  Familial chordoma, a tumor of notochordal remnants, is linked to chromosome 7q33. Am J Hum Genet. 2001 Aug;69(2):454-60. doi: 10.1086/321982. Epub 2001 Jul 10.
•   Kim JE, Pang J, Christensen JM, Coon D, Zadnik PL, Wolinsky JP, Gokaslan ZL, Bydon A, Sciubba DM, Witham T, Redett RJ, Sacks JM
  Soft-tissue reconstruction after total en bloc sacrectomy. J Neurosurg Spine. 2015 Jun;22(6):571-81. doi: 10.3171/2014.10.SPINE14114. Epub 2015 Mar 27.
•   Lee-Jones L, Aligianis I, Davies PA, Puga A, Farndon PA, Stemmer-Rachamimov A, Ramesh V, Sampson JR
  Sacrococcygeal chordomas in patients with tuberous sclerosis complex show somatic loss of TSC1 or TSC2. Genes Chromosomes Cancer. 2004 Sep;41(1):80-5. doi: 10.1002/gcc.20052.
•   Li J, Scheike TH, Zhang MJ
  Checking Fine and Gray subdistribution hazards model with cumulative sums of residuals. Lifetime Data Anal. 2015 Apr;21(2):197-217. doi: 10.1007/s10985-014-9313-9. Epub 2014 Nov 25.
•   Maricevich M, Maricevich R, Chim H, Moran SL, Rose PS, Mardini S
  Reconstruction following partial and total sacrectomy defects: an analysis of outcomes and complications. J Plast Reconstr Aesthet Surg. 2014 Sep;67(9):1257-66. doi: 10.1016/j.bjps.2014.05.001. Epub 2014 May 20.
•   McCandless LC, Gustafson P, Levy AR, Richardson S
  Hierarchical priors for bias parameters in Bayesian sensitivity analysis for unmeasured confounding. Stat Med. 2012 Feb 20;31(4):383-96. doi: 10.1002/sim.4453.
•   Mima M, Demizu Y, Jin D, Hashimoto N, Takagi M, Terashima K, Fujii O, Niwa Y, Akagi T, Daimon T, Hishikawa Y, Abe M, Murakami M, Sasaki R, Fuwa N
  Particle therapy using carbon ions or protons as a definitive therapy for patients with primary sacral chordoma. Br J Radiol. 2014 Jan;87(1033):20130512. doi: 10.1259/bjr.20130512. Epub 2013 Nov 28.
•   Miozzo M, Dalpra L, Riva P, Volonta M, Macciardi F, Pericotti S, Tibiletti MG, Cerati M, Rohde K, Larizza L, Fuhrman Conti AM
  A tumor suppressor locus in familial and sporadic chordoma maps to 1p36. Int J Cancer. 2000 Jul 1;87(1):68-72.
•   Oakley GJ, Fuhrer K, Seethala RR
  Brachyury, SOX-9, and podoplanin, new markers in the skull base chordoma vs chondrosarcoma differential: a tissue microarray-based comparative analysis. Mod Pathol. 2008 Dec;21(12):1461-9. doi: 10.1038/modpathol.2008.144. Epub 2008 Sep 26.
•   Peduzzi P, Concato J, Feinstein AR, Holford TR
  Importance of events per independent variable in proportional hazards regression analysis. II. Accuracy and precision of regression estimates. J Clin Epidemiol. 1995 Dec;48(12):1503-10. doi: 10.1016/0895-4356(95)00048-8.
•   Puri A, Agarwal MG, Shah M, Srinivas CH, Shukla PJ, Shrikhande SV, Jambhekar NA
  Decision making in primary sacral tumors. Spine J. 2009 May;9(5):396-403. doi: 10.1016/j.spinee.2008.10.001. Epub 2008 Dec 6.
•   Royston P, Parmar MK
  The use of restricted mean survival time to estimate the treatment effect in randomized clinical trials when the proportional hazards assumption is in doubt. Stat Med. 2011 Aug 30;30(19):2409-21. doi: 10.1002/sim.4274. Epub 2011 May 25.
•   Schwab JH, Boland PJ, Agaram NP, Socci ND, Guo T, O'Toole GC, Wang X, Ostroumov E, Hunter CJ, Block JA, Doty S, Ferrone S, Healey JH, Antonescu CR
  Chordoma and chondrosarcoma gene profile: implications for immunotherapy. Cancer Immunol Immunother. 2009 Mar;58(3):339-49. doi: 10.1007/s00262-008-0557-7. Epub 2008 Jul 19.
•   Staab A, Rutz HP, Ares C, Timmermann B, Schneider R, Bolsi A, Albertini F, Lomax A, Goitein G, Hug E
  Spot-scanning-based proton therapy for extracranial chordoma. Int J Radiat Oncol Biol Phys. 2011 Nov 15;81(4):e489-96. doi: 10.1016/j.ijrobp.2011.02.018. Epub 2011 Apr 15.
•   Stablein DM, Carter WH Jr, Novak JW
  Analysis of survival data with nonproportional hazard functions. Control Clin Trials. 1981 Jun;2(2):149-59. doi: 10.1016/0197-2456(81)90005-2.
•   Stacchiotti S, Casali PG, Lo Vullo S, Mariani L, Palassini E, Mercuri M, Alberghini M, Pilotti S, Zanella L, Gronchi A, Picci P
  Chordoma of the mobile spine and sacrum: a retrospective analysis of a series of patients surgically treated at two referral centers. Ann Surg Oncol. 2010 Jan;17(1):211-9. doi: 10.1245/s10434-009-0740-x. Epub 2009 Oct 22.
•   Stacchiotti S, Sommer J; Chordoma Global Consensus Group
  Building a global consensus approach to chordoma: a position paper from the medical and patient community. Lancet Oncol. 2015 Feb;16(2):e71-83. doi: 10.1016/S1470-2045(14)71190-8.
•   Steinstrater O, Grun R, Scholz U, Friedrich T, Durante M, Scholz M
  Mapping of RBE-weighted doses between HIMAC- and LEM-Based treatment planning systems for carbon ion therapy. Int J Radiat Oncol Biol Phys. 2012 Nov 1;84(3):854-60. doi: 10.1016/j.ijrobp.2012.01.038. Epub 2012 Apr 6.
•   Stiller CA, Trama A, Brewster DH, Verne J, Bouchardy C, Navarro C, Chirlaque MD, Marcos-Gragera R, Visser O, Serraino D, Weiderpass E, Dei Tos AP, Ascoli V; RARECARE Working Group
  Descriptive epidemiology of Kaposi sarcoma in Europe. Report from the RARECARE project. Cancer Epidemiol. 2014 Dec;38(6):670-8. doi: 10.1016/j.canep.2014.09.009. Epub 2014 Oct 22.
•   Terezakis SA, Lovelock DM, Bilsky MH, Hunt MA, Zatcky J, Yamada Y
  Image-guided intensity-modulated photon radiotherapy using multifractionated regimen to paraspinal chordomas and rare sarcomas. Int J Radiat Oncol Biol Phys. 2007 Dec 1;69(5):1502-8. doi: 10.1016/j.ijrobp.2007.05.019. Epub 2007 Aug 6.
•   Tirabosco R, Mangham DC, Rosenberg AE, Vujovic S, Bousdras K, Pizzolitto S, De Maglio G, den Bakker MA, Di Francesco L, Kalil RK, Athanasou NA, O'Donnell P, McCarthy EF, Flanagan AM
  Brachyury expression in extra-axial skeletal and soft tissue chordomas: a marker that distinguishes chordoma from mixed tumor/myoepithelioma/parachordoma in soft tissue. Am J Surg Pathol. 2008 Apr;32(4):572-80. doi: 10.1097/PAS.0b013e31815b693a.
•   Uhl M, Edler L, Jensen AD, Habl G, Oelmann J, Roder F, Jackel O, Debus J, Herfarth K
  Randomized phase II trial of hypofractionated proton versus carbon ion radiation therapy in patients with sacrococcygeal chordoma-the ISAC trial protocol. Radiat Oncol. 2014 Apr 29;9:100. doi: 10.1186/1748-717X-9-100.
•   Varga PP, Szoverfi Z, Fisher CG, Boriani S, Gokaslan ZL, Dekutoski MB, Chou D, Quraishi NA, Reynolds JJ, Luzzati A, Williams R, Fehlings MG, Germscheid NM, Lazary A, Rhines LD
  Surgical treatment of sacral chordoma: prognostic variables for local recurrence and overall survival. Eur Spine J. 2015 May;24(5):1092-101. doi: 10.1007/s00586-014-3728-6. Epub 2014 Dec 23.
•   Vujovic S, Henderson S, Presneau N, Odell E, Jacques TS, Tirabosco R, Boshoff C, Flanagan AM
  Brachyury, a crucial regulator of notochordal development, is a novel biomarker for chordomas. J Pathol. 2006 Jun;209(2):157-65. doi: 10.1002/path.1969.
•   Walcott BP, Nahed BV, Mohyeldin A, Coumans JV, Kahle KT, Ferreira MJ
  Chordoma: current concepts, management, and future directions. Lancet Oncol. 2012 Feb;13(2):e69-76. doi: 10.1016/S1470-2045(11)70337-0.
•   Weitao Y, Qiqing C, Songtao G, Jiaqiang W
  Use of gluteus maximus adipomuscular sliding flaps in the reconstruction of sacral defects after tumor resection. World J Surg Oncol. 2013 May 23;11:110. doi: 10.1186/1477-7819-11-110.
•   Yamada Y, Laufer I, Cox BW, Lovelock DM, Maki RG, Zatcky JM, Boland PJ, Bilsky MH
  Preliminary results of high-dose single-fraction radiotherapy for the management of chordomas of the spine and sacrum. Neurosurgery. 2013 Oct;73(4):673-80; discussion 680. doi: 10.1227/NEU.0000000000000083.
•   Yanagi T, Kamada T, Tsuji H, Imai R, Serizawa I, Tsujii H
  Dose-volume histogram and dose-surface histogram analysis for skin reactions to carbon ion radiotherapy for bone and soft tissue sarcoma. Radiother Oncol. 2010 Apr;95(1):60-5. doi: 10.1016/j.radonc.2009.08.041. Epub 2009 Sep 18.
•   Yang XR, Ng D, Alcorta DA, Liebsch NJ, Sheridan E, Li S, Goldstein AM, Parry DM, Kelley MJ
  T (brachyury) gene duplication confers major susceptibility to familial chordoma. Nat Genet. 2009 Nov;41(11):1176-8. doi: 10.1038/ng.454. Epub 2009 Oct 4.
•   Yuo TH, Degenholtz HS, Chaer RA, Kraemer KL, Makaroun MS
  Effect of hospital-level variation in the use of carotid artery stenting versus carotid endarterectomy on perioperative stroke and death in asymptomatic patients. J Vasc Surg. 2013 Mar;57(3):627-34. doi: 10.1016/j.jvs.2012.09.036. Epub 2013 Jan 9.
•   Zabel-du Bois A, Nikoghosyan A, Schwahofer A, Huber P, Schlegel W, Debus J, Milker-Zabel S
  Intensity modulated radiotherapy in the management of sacral chordoma in primary versus recurrent disease. Radiother Oncol. 2010 Dec;97(3):408-12. doi: 10.1016/j.radonc.2010.10.008. Epub 2010 Nov 4.
•   Zhang HY, Thongtrangan I, Balabhadra RS, Murovic JA, Kim DH
  Surgical techniques for total sacrectomy and spinopelvic reconstruction. Neurosurg Focus. 2003 Aug 15;15(2):E5. doi: 10.3171/foc.2003.15.2.5.

Title of Study: SAcral Chordoma: a Randomized & Observational Study on Surgery Versus Definitive Radiation Therapy in Primary Localized Disease (SACRO)

Details for clinical trial NCT02986516