Sacral Chordoma: Surgery Versus Definitive Radiation Therapy in Primary Localized Disease
NCT ID: NCT02986516
Last Updated: 2024-12-20
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
RECRUITING
Clinical Phase
NA
Total Enrollment
100 participants
Study Classification
INTERVENTIONAL
Study Start Date
2017-03-16
Study Completion Date
2025-09-30
Brief Summary
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Comparative study on surgery versus definitive radiation therapy in primary localized sacral chordoma
Detailed Description
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International, multicenter, comparative, open-label, parallel-group, mixed Observational-Randomized Controlled Trial.
All the patients, who are candidate for the study will receive full information on the characteristics, potential effectiveness and side effects of the two alternatives treatments: radiotherapy (RT) and surgical treatment Eligible patients will be asked to be randomized in order to receive treatment A (surgery, with or without RT) or treatment B (definitive RT) Who will refuse randomization will be included in the Prospective Cohort Study (PCS) and will be treated accordingly to their choice (treatment option A or treatment option B).
The same radiotherapy and surgical regimen will be administered in the PCS and in the Randomized Clinical Trial (RCT) cohort
All the patients, who are candidate for the study will receive full information on the characteristics, potential effectiveness and side effects of the two alternatives treatments: radiotherapy (RT) and surgical treatment Eligible patients will be asked to be randomized in order to receive treatment A (surgery, with or without RT) or treatment B (definitive RT) Who will refuse randomization will be included in the Prospective Cohort Study (PCS) and will be treated accordingly to their choice (treatment option A or treatment option B).
The same radiotherapy and surgical regimen will be administered in the PCS and in the Randomized Clinical Trial (RCT) cohort
Conditions
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Chordoma
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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Randomized Cohort
Participants who will decided to undergo to randomization, will receive surgical treatment or definitive radiotherapy according with randomization assignment
Group Type
EXPERIMENTAL
Randomized Cohort
Intervention Type
OTHER
Surgical treatment with different approach, based on the characteristics of the tumor or definitive high dose radiotherapy (carbon ion radiotherapy, proton-therapy, mixed photons-proton therapy) will be assigned by randomization
Prospective Cohort
Participants who will not decide to be randomized, will received the surgical or definite radiotherapy treatment according to their choice
Group Type
ACTIVE_COMPARATOR
Prospective cohort
Intervention Type
RADIATION
Surgical treatment or definitive high dose radiotherapy will be selected by the patients and will be prospectively evaluated
Interventions
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Randomized Cohort
Surgical treatment with different approach, based on the characteristics of the tumor or definitive high dose radiotherapy (carbon ion radiotherapy, proton-therapy, mixed photons-proton therapy) will be assigned by randomization
Intervention Type
OTHER
Prospective cohort
Surgical treatment or definitive high dose radiotherapy will be selected by the patients and will be prospectively evaluated
Intervention Type
RADIATION
Eligibility Criteria
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Inclusion Criteria
* Histologically confirmed diagnosis (brachyury expression) of primary sacral chordoma,of any diameter and arising at any site from S1 to coccyx.
* Age≥18years
* ECOG-performance status (PS) 0-2
* No previous antineoplastic therapy
* Macroscopic tumor detectable at MRI/CT scan
* Patient amenable for surgery
* Patient amenable for RT
* Written informed consent given before the enrolment, according to International Conference on Harmonisation/good clinical practice (ICH/GCP).
* Age≥18years
* ECOG-performance status (PS) 0-2
* No previous antineoplastic therapy
* Macroscopic tumor detectable at MRI/CT scan
* Patient amenable for surgery
* Patient amenable for RT
* Written informed consent given before the enrolment, according to International Conference on Harmonisation/good clinical practice (ICH/GCP).
Exclusion Criteria
* Distant metastasis
* Inability to maintain treatment position
* Prior radiotherapy to the pelvic region
* Prior therapy for sacral chordoma (including surgery, cryoablation, hyperthermia, etc)
* Local conditions that increase the risk of RT toxicity (tumor ulcerated skin infiltration, non-healing soft tissue infection, fistula in treatment field)
* Rectal wall infiltration
* General conditions that increase the risk of RT toxicity (active sclerodermia, xeroderma pigmentosum, cutaneous porphyria)
* Presence of a second active cancer (with the exception of non-melanoma skin cancer in-situ cervix neoplasia and other in-situ neoplasia)
* Severe comorbidities resulting in a prognosis of less than 6 months
* Inability to give informed consent
* Other malignancy within the last 5 years
* Performance status ≥ 2 (ECOG).
* Significant cardiovascular disease (for example, dyspnea \> 2 NYHA)
* Significant systemic diseases grade \>3 on the NCI-CTCAE v4.03 scale, that limit patient availability, or according to investigator judgment may contribute significantly to treatment toxicity
* Women who are pregnant or breast-feeding
* Psychological, familial, social or geographic circumstances that limit the patient's ability to comply with the protocol or informed consent
* Inability to maintain treatment position
* Prior radiotherapy to the pelvic region
* Prior therapy for sacral chordoma (including surgery, cryoablation, hyperthermia, etc)
* Local conditions that increase the risk of RT toxicity (tumor ulcerated skin infiltration, non-healing soft tissue infection, fistula in treatment field)
* Rectal wall infiltration
* General conditions that increase the risk of RT toxicity (active sclerodermia, xeroderma pigmentosum, cutaneous porphyria)
* Presence of a second active cancer (with the exception of non-melanoma skin cancer in-situ cervix neoplasia and other in-situ neoplasia)
* Severe comorbidities resulting in a prognosis of less than 6 months
* Inability to give informed consent
* Other malignancy within the last 5 years
* Performance status ≥ 2 (ECOG).
* Significant cardiovascular disease (for example, dyspnea \> 2 NYHA)
* Significant systemic diseases grade \>3 on the NCI-CTCAE v4.03 scale, that limit patient availability, or according to investigator judgment may contribute significantly to treatment toxicity
* Women who are pregnant or breast-feeding
* Psychological, familial, social or geographic circumstances that limit the patient's ability to comply with the protocol or informed consent
Minimum Eligible Age
18 Years
Maximum Eligible Age
80 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Italian Sarcoma Group
NETWORK
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Alessandro Gronchi, MD
Role: PRINCIPAL_INVESTIGATOR
Istituto Nazionale Tumori Milan-Italy
Piero Fossati, MD
Role: PRINCIPAL_INVESTIGATOR
MedAustron Graz-Austria
Locations
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Medical University of Graz
Graz, , Austria
Site Status
RECRUITING
EBG GmbH MedAustron
Wiener Neustadt, Österreich, Austria
Site Status
RECRUITING
Medical Faculty Carl Gustav Carus Faculty of Medicine, Department of Radiation Oncology,
Dresden, , Germany
Site Status
NOT_YET_RECRUITING
University Hospital Carl Gustav Carus Dresden
Dresden, , Germany
Site Status
NOT_YET_RECRUITING
University Hospital Essen. West German Proton Therapy Center Essen
Essen, , Germany
Site Status
RECRUITING
Heidelberg Ion-Beam Therapy Center - HIT
Heidelberg, , Germany
Site Status
NOT_YET_RECRUITING
National Center for Spinal Disorders
Budapest, , Hungary
Site Status
NOT_YET_RECRUITING
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, MI, Italy
Site Status
RECRUITING
Istituto Ortopedico Rizzoli
Bologna, , Italy
Site Status
RECRUITING
Azienda Ospedaliero-Universitaria Careggi
Florence, , Italy
Site Status
NOT_YET_RECRUITING
Istituto Clinico Humanitas
Milan, , Italy
Site Status
RECRUITING
I.R.C.C.S. Istituto Ortopedico Galeazzi
Milan, , Italy
Site Status
ACTIVE_NOT_RECRUITING
Centro Nazionale di Adroterapia Oncologica - CNAO
Pavia, , Italy
Site Status
RECRUITING
II Clinica Universitaria Ortopedia e Traumatologia AO Pisa
Pisa, , Italy
Site Status
RECRUITING
Istituto Regina Elena - IFO
Rome, , Italy
Site Status
RECRUITING
Agenzia Provinciale per la Protonterapia - AtreP
Trento, , Italy
Site Status
ACTIVE_NOT_RECRUITING
Saitama Medical Center
Saitama, , Japan
Site Status
RECRUITING
Netherlands Cancer Institute
Amsterdam, , Netherlands
Site Status
NOT_YET_RECRUITING
Leiden University Medical Center
Leiden, , Netherlands
Site Status
NOT_YET_RECRUITING
Norwegian Radium Hospital/Oslo Univeristi Hospital
Oslo, , Norway
Site Status
RECRUITING
Centrum Onkologii-Instytut im. Marii Skłodowskiej-Curie
Warsaw, , Poland
Site Status
ACTIVE_NOT_RECRUITING
H. Val D'Hebron
Barcelona, , Spain
Site Status
RECRUITING
Hosptial San Pau
Barcelona, , Spain
Site Status
ACTIVE_NOT_RECRUITING
H. San Carlos
Madrid, , Spain
Site Status
NOT_YET_RECRUITING
Hospital Universitario Virgen del Rocío
Seville, , Spain
Site Status
RECRUITING
Hospital Universitario Doctor Peset
Valencia, , Spain
Site Status
NOT_YET_RECRUITING
The Royal Orthopaedic Hospital
Birmingham, , United Kingdom
Site Status
NOT_YET_RECRUITING
Royal National Orthopaedic Hospital
London, , United Kingdom
Site Status
NOT_YET_RECRUITING
Countries
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Austria
Germany
Hungary
Italy
Japan
Netherlands
Norway
Poland
Spain
United Kingdom
Central Contacts
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Facility Contacts
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Andreas Leithner, MD
Role: primary
Piero Fossati, MD
Role: primary
Mechthild Krause, Prof/MD
Role: primary
Mechthild Krause, MD
Role: primary
Beate Timmermann, MD
Role: primary
Matthias Uhl, MD
Role: primary
Peter P Varga, MD
Role: primary
Alessandro Gronchi, MD
Role: primary
Alessandro Gasbarrini, MD
Role: primary
Domenico A Campanacci, MD
Role: primary
Ferdinando Cananzi, MD
Role: primary
Maria Rosaria Fiore, MD
Role: primary
Lorenzo Andreani, MD
Role: primary
Maria Grazia Petrongari, MD
Role: primary
Toru Akiyama, MD
Role: primary
R LM Haas, MD
Role: primary
Sander Dijkstra, MD
Role: primary
Øyvind S. Bruland, MD
Role: primary
Øyvind S. Bruland, MD
Role: backup
Ramona V. Capdevila, MD
Role: primary
Gloria M. Ospina, MD
Role: primary
Nadia Hindi, MD
Role: primary
Antonio M. Benlloch, MD
Role: primary
Lee Jeys, MD
Role: primary
Rob Pollock, MD
Role: primary
References
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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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
Brien EW, Mirra JM, Ippolito V. Chondroblastoma arising from a nonepiphyseal site. Skeletal Radiol. 1995 Apr;24(3):220-2. doi: 10.1007/BF00228930.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
ISG SACRO
Identifier Type: -
Identifier Source: org_study_id