Back to results

Sacral Chordoma: Surgery Versus Definitive Radiation Therapy in Primary Localized Disease (SACRO)

Primary Purpose

Chordoma

Status

Recruiting

Phase

Not Applicable

Locations

International

Study Type

Interventional

Intervention

Randomized Cohort

Prospective cohort

About this trial

This is an interventional treatment trial for Chordoma

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

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

Sites / Locations

Medical University of GrazRecruiting
EBG GmbH MedAustronRecruiting
Medical Faculty Carl Gustav Carus Faculty of Medicine, Department of Radiation Oncology,
University Hospital Carl Gustav Carus Dresden
University Hospital Essen. West German Proton Therapy Center EssenRecruiting
Heidelberg Ion-Beam Therapy Center - HIT
National Center for Spinal Disorders
Fondazione IRCCS Istituto Nazionale dei TumoriRecruiting
Istituto Ortopedico RizzoliRecruiting
Azienda Ospedaliero-Universitaria Careggi
Istituto Clinico HumanitasRecruiting
I.R.C.C.S. Istituto Ortopedico Galeazzi
Centro Nazionale di Adroterapia Oncologica - CNAORecruiting
II Clinica Universitaria Ortopedia e Traumatologia AO PisaRecruiting
Istituto Regina Elena - IFORecruiting
Agenzia Provinciale per la Protonterapia - AtreP
Saitama Medical CenterRecruiting
Netherlands Cancer Institute
Leiden University Medical Center
Norwegian Radium Hospital/Oslo Univeristi HospitalRecruiting
Centrum Onkologii-Instytut im. Marii Skłodowskiej-Curie
H. Val D'HebronRecruiting
Hosptial San Pau
H. San Carlos
Hospital Universitario Virgen del RocíoRecruiting
Hospital Universitario Doctor Peset
The Royal Orthopaedic Hospital
Royal National Orthopaedic Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Randomized Cohort

Prospective Cohort

Arm Description

Participants who will decided to undergo to randomization, will receive surgical treatment or definitive radiotherapy according with randomization assignment

Participants who will not decide to be randomized, will received the surgical or definite radiotherapy treatment according to their choice

Outcomes

Primary Outcome Measures

Relapse Free Survival (RFS)

The time from randomization or treatment start date to the date of local disease relapse, distant disease relapse, second primary malignancy or death from any cause, whichever occurred first.

Secondary Outcome Measures

Overall Survival (OS)

The time from randomization or treatment start date to the date of death from any cause

Survival Post Progression (SPP)

The time from local disease relapse, distant disease relapse or second primary malignancy, whichever occurred first, to the date of death from any cause

Local Relapse Failure (LRF)

The time from randomization or treatment start date to the date of local disease relapse

Distant Relapse Failure (DRF)

The time from randomization or treatment start date to the date of distant disease relapse

Best Response rate to definitive radiotherapy

Time to best response rate to definitive radiotherapy

Adverse Events Incidence

Adverse Events incidence

Evaluation of quality of life measured with Functional Assessment of Cancer Therapy General

Evaluation of quality of life measured with Brief Inventory Pain questionnaires

Full Information

NCT ID

NCT02986516

First Posted

December 2, 2016

Last Updated

September 12, 2023

Sponsor

Italian Sarcoma Group

1. Study Identification

Unique Protocol Identification Number

NCT02986516

Brief Title

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

Acronym

SACRO

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Recruiting

Study Start Date

March 16, 2017 (Actual)

Primary Completion Date

September 2024 (Anticipated)

Study Completion Date

September 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Italian Sarcoma Group

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

Comparative study on surgery versus definitive radiation therapy in primary localized sacral chordoma

Detailed Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chordoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Randomized Cohort

Arm Type

Experimental

Arm Description

Participants who will decided to undergo to randomization, will receive surgical treatment or definitive radiotherapy according with randomization assignment

Arm Title

Prospective Cohort

Arm Type

Active Comparator

Arm Description

Participants who will not decide to be randomized, will received the surgical or definite radiotherapy treatment according to their choice

Intervention Type

Other

Intervention Name(s)

Randomized Cohort

Intervention Description

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

Radiation

Intervention Name(s)

Prospective cohort

Intervention Description

Surgical treatment or definitive high dose radiotherapy will be selected by the patients and will be prospectively evaluated

Primary Outcome Measure Information:

Title

Relapse Free Survival (RFS)

Description

The time from randomization or treatment start date to the date of local disease relapse, distant disease relapse, second primary malignancy or death from any cause, whichever occurred first.

Time Frame

5 years

Secondary Outcome Measure Information:

Title

Overall Survival (OS)

Description

The time from randomization or treatment start date to the date of death from any cause

Time Frame

The patients will be followed in term of Overall Survival, for all the study period (expected average: 10 years)

Title

Survival Post Progression (SPP)

Description

The time from local disease relapse, distant disease relapse or second primary malignancy, whichever occurred first, to the date of death from any cause

Time Frame

Expected average: 36 months

Title

Local Relapse Failure (LRF)

Description

The time from randomization or treatment start date to the date of local disease relapse

Time Frame

Expected average: 60 months

Title

Distant Relapse Failure (DRF)

Description

The time from randomization or treatment start date to the date of distant disease relapse

Time Frame

Expected average: 60 months

Title

Best Response rate to definitive radiotherapy

Description

Best Response rate to definitive radiotherapy

Time Frame

At 12 months, 2 years and 5 years after radiotherapy

Title

Time to best response rate to definitive radiotherapy

Description

Time to best response rate to definitive radiotherapy

Time Frame

At 12 months, 2 years and 5 years after radiotherapy

Title

Adverse Events Incidence

Description

Adverse Events incidence

Time Frame

At end of treatment , 6 months , 12 months 2 years and 5 years after surgery or radiotherapy

Title

Evaluation of quality of life measured with Functional Assessment of Cancer Therapy General

Description

Evaluation of quality of life measured with Functional Assessment of Cancer Therapy General

Time Frame

every 6 months (expected average: 5 years)

Title

Evaluation of quality of life measured with Brief Inventory Pain questionnaires

Description

Evaluation of quality of life measured with Brief Inventory Pain questionnaires

Time Frame

every 6 months (expected average: 5 years)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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). 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Alessandro Gronchi, MD

Phone

+390223903714

alessandro.gronchi@istitutotumori.mi.it

First Name & Middle Initial & Last Name or Official Title & Degree

ISG Clinical Trial Center

clinicaltrials@italiansarcomagroup.org

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Alessandro Gronchi, MD

Organizational Affiliation

Istituto Nazionale Tumori Milan-Italy

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Piero Fossati, MD

Organizational Affiliation

MedAustron Graz-Austria

Official's Role

Principal Investigator

Facility Information:

Facility Name

Medical University of Graz

City

Graz

Country

Austria

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Andreas Leithner, MD

First Name & Middle Initial & Last Name & Degree

Andreas Leithner, MD

Facility Name

EBG GmbH MedAustron

City

Wiener Neustadt

State/Province

Österreich

ZIP/Postal Code

2700

Country

Austria

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Piero Fossati, MD

Phone

+43 2622 26100

Ext

408

piero.fossati@medaustron.at

Facility Name

Medical Faculty Carl Gustav Carus Faculty of Medicine, Department of Radiation Oncology,

City

Dresden

Country

Germany

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Mechthild Krause, Prof/MD

First Name & Middle Initial & Last Name & Degree

Mechthild Krause, Prof/MD

Facility Name

University Hospital Carl Gustav Carus Dresden

City

Dresden

Country

Germany

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Mechthild Krause, MD

First Name & Middle Initial & Last Name & Degree

Mechthild Krause, MD

Facility Name

University Hospital Essen. West German Proton Therapy Center Essen

City

Essen

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Beate Timmermann, MD

First Name & Middle Initial & Last Name & Degree

Beate Timmermann, MD

Facility Name

Heidelberg Ion-Beam Therapy Center - HIT

City

Heidelberg

Country

Germany

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Matthias Uhl, MD

First Name & Middle Initial & Last Name & Degree

Matthias Uhl, MD

Facility Name

National Center for Spinal Disorders

City

Budapest

Country

Hungary

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Peter P Varga, MD

First Name & Middle Initial & Last Name & Degree

Peter P Varga, MD

Facility Name

Fondazione IRCCS Istituto Nazionale dei Tumori

City

Milano

State/Province

ZIP/Postal Code

20133

Country

Italy

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Alessandro Gronchi, MD

alessandro.gronchi@istitutotumori.mi.it

First Name & Middle Initial & Last Name & Degree

Alessandro Gronchi, MD

Facility Name

Istituto Ortopedico Rizzoli

City

Bologna

ZIP/Postal Code

40136

Country

Italy

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Alessandro Gasbarrini, MD

Phone

+390516366

Ext

066

alessandro.gasbarrini@ior.it

First Name & Middle Initial & Last Name & Degree

Alessandro Gasbarrini, MD

Facility Name

Azienda Ospedaliero-Universitaria Careggi

City

Firenze

ZIP/Postal Code

50134

Country

Italy

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Domenico A Campanacci, MD

First Name & Middle Initial & Last Name & Degree

Domenico A Campanacci, MD

Facility Name

Istituto Clinico Humanitas

City

Milano

ZIP/Postal Code

20089

Country

Italy

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ferdinando Cananzi, MD

ferdinando.cananzi@hunimed.eu

First Name & Middle Initial & Last Name & Degree

Ferdinando Cananzi, MD

Facility Name

I.R.C.C.S. Istituto Ortopedico Galeazzi

City

Milano

ZIP/Postal Code

20161

Country

Italy

Individual Site Status

Active, not recruiting

Facility Name

Centro Nazionale di Adroterapia Oncologica - CNAO

City

Pavia

ZIP/Postal Code

27100

Country

Italy

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Maria Rosaria Fiore, MD

MariaRosaria.Fiore@Cnao.it

First Name & Middle Initial & Last Name & Degree

Maria Rosaria Fiore, MD

Facility Name

II Clinica Universitaria Ortopedia e Traumatologia AO Pisa

City

Pisa

ZIP/Postal Code

56124

Country

Italy

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Lorenzo Andreani, MD

lorenzo.andreani.unipi@gmail.com

First Name & Middle Initial & Last Name & Degree

Lorenzo Andreani, MD

Facility Name

Istituto Regina Elena - IFO

City

Rome

ZIP/Postal Code

00100

Country

Italy

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Maria Grazia Petrongari, MD

Phone

+39065266

Ext

6894

mariagrazia.petrongari@ifo.gov.it

First Name & Middle Initial & Last Name & Degree

Maria Grazia Petrongari, MD

Facility Name

Agenzia Provinciale per la Protonterapia - AtreP

City

Trento

ZIP/Postal Code

38122

Country

Italy

Individual Site Status

Active, not recruiting

Facility Name

Saitama Medical Center

City

Saitama

Country

Japan

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Toru Akiyama, MD

First Name & Middle Initial & Last Name & Degree

Toru Akiyama, MD

Facility Name

Netherlands Cancer Institute

City

Amsterdam

Country

Netherlands

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

R LM Haas, MD

First Name & Middle Initial & Last Name & Degree

R LM Haas, MD

Facility Name

Leiden University Medical Center

City

Leiden

Country

Netherlands

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Sander Dijkstra, MD

First Name & Middle Initial & Last Name & Degree

Sander Dijkstra, MD

Facility Name

Norwegian Radium Hospital/Oslo Univeristi Hospital

City

Oslo

ZIP/Postal Code

N-0424

Country

Norway

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Øyvind S. Bruland, MD

Phone

+47 22 93 47

Ext

osb@ous-hf.no

First Name & Middle Initial & Last Name & Degree

Øyvind S. Bruland, MD

Facility Name

Centrum Onkologii-Instytut im. Marii Skłodowskiej-Curie

City

Warsaw

Country

Poland

Individual Site Status

Active, not recruiting

Facility Name

H. Val D'Hebron

City

Barcelona

Country

Spain

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ramona V. Capdevila, MD

First Name & Middle Initial & Last Name & Degree

Ramona V. Capdevila, MD

Facility Name

Hosptial San Pau

City

Barcelona

Country

Spain

Individual Site Status

Active, not recruiting

Facility Name

H. San Carlos

City

Madrid

Country

Spain

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Gloria M. Ospina, MD

First Name & Middle Initial & Last Name & Degree

Gloria M. Ospina

Facility Name

Hospital Universitario Virgen del Rocío

City

Sevilla

Country

Spain

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Nadia Hindi, MD

First Name & Middle Initial & Last Name & Degree

Nadia Hindi, MD

Facility Name

Hospital Universitario Doctor Peset

City

Valencia

ZIP/Postal Code

46017

Country

Spain

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Antonio M. Benlloch, MD

antonio.martin@uv.es

First Name & Middle Initial & Last Name & Degree

Antonio M. Benlloch, MD

Facility Name

The Royal Orthopaedic Hospital

City

Birmingham

Country

United Kingdom

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Lee Jeys, MD

First Name & Middle Initial & Last Name & Degree

Lee Jeys, MD

Facility Name

Royal National Orthopaedic Hospital

City

London

Country

United Kingdom

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Rob Pollock, MD

First Name & Middle Initial & Last Name & Degree

Rob Pollock, MD

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

25454979

Citation

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.

Results Reference

background

PubMed Identifier

18301055

Citation

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.

Results Reference

background

PubMed Identifier

7610417

Citation

Brien EW, Mirra JM, Ippolito V. Chondroblastoma arising from a nonepiphyseal site. Skeletal Radiol. 1995 Apr;24(3):220-2. doi: 10.1007/BF00228930.

Results Reference

background

PubMed Identifier

16538613

Citation

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.

Results Reference

background

PubMed Identifier

10861454

Citation

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.

Results Reference

background

PubMed Identifier

11452362

Citation

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.

Results Reference

background

PubMed Identifier

15236319

Citation

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.

Results Reference

background

PubMed Identifier

1233436

Citation

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.

Results Reference

background

PubMed Identifier

19801981

Citation

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.

Results Reference

background

PubMed Identifier

18641983

Citation

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.

Results Reference

background

PubMed Identifier

18820665

Citation

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.

Results Reference

background

PubMed Identifier

22300861

Citation

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.

Results Reference

background

PubMed Identifier

25638683

Citation

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.

Results Reference

background

PubMed Identifier

24469886

Citation

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.

Results Reference

background

PubMed Identifier

22038441

Citation

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.

Results Reference

background

PubMed Identifier

19847568

Citation

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.

Results Reference

background

PubMed Identifier

25533857

Citation

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.

Results Reference

background

PubMed Identifier

24793103

Citation

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.

Results Reference

background

PubMed Identifier

19059810

Citation

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.

Results Reference

background

PubMed Identifier

22009849

Citation

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.

Results Reference

background

PubMed Identifier

3611160

Citation

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.

Results Reference

background

PubMed Identifier

22569060

Citation

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.

Results Reference

background

PubMed Identifier

23701700

Citation

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.

Results Reference

background

PubMed Identifier

12897508

Citation

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.

Results Reference

background

PubMed Identifier

15350036

Citation

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.

Results Reference

background

PubMed Identifier

25815806

Citation

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.

Results Reference

background

PubMed Identifier

24907194

Citation

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.

Results Reference

background

PubMed Identifier

21427182

Citation

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.

Results Reference

background

PubMed Identifier

19767117

Citation

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.

Results Reference

background

PubMed Identifier

24288399

Citation

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.

Results Reference

background

PubMed Identifier

24774721

Citation

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.

Results Reference

background

PubMed Identifier

23104051

Citation

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.

Results Reference

background

PubMed Identifier

22483698

Citation

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.

Results Reference

background

PubMed Identifier

19095372

Citation

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.

Results Reference

background

PubMed Identifier

24752878

Citation

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.

Results Reference

background

PubMed Identifier

23609202

Citation

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.

Results Reference

background

PubMed Identifier

21497457

Citation

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.

Results Reference

background

PubMed Identifier

17689028

Citation

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.

Results Reference

background

PubMed Identifier

23842548

Citation

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.

Results Reference

background

PubMed Identifier

21056488

Citation

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.

Results Reference

background

PubMed Identifier

19165073

Citation

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.

Results Reference

background

PubMed Identifier

21611958

Citation

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.

Results Reference

background

PubMed Identifier

7273792

Citation

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.

Results Reference

background

PubMed Identifier

25421251

Citation

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.

Results Reference

background

PubMed Identifier

22253142

Citation

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.

Results Reference

background

PubMed Identifier

8543964

Citation

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.

Results Reference

background

PubMed Identifier

23312937

Citation

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.

Results Reference

background

Learn more about this trial

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

We'll reach out to this number within 24 hrs