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ChordomaSACRONCT02986516

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

A study testing Randomized Cohort and Prospective cohort in people with Chordoma, run by Italian Sarcoma Group at 28 sites in 10 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Comparative study on surgery versus definitive radiation therapy in primary localized sacral chordoma Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Chordoma
What is being tested?
Randomized Cohort and Prospective cohort
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
28 sitesin 10 countries
Study dates
16 Mar 2017to 31 Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).

Who cannot join

  • 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
Show all 16Show fewer
  • 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

Trial locations and contacts

28 sites in 10 countries. Contact the study team or a site near you to ask about taking part.

Alessandro Gronchi, MD contact

+390223903714

alessandro.gronchi@istitutotumori.mi.it

ISG Clinical Trial Center contact

clinicaltrials@italiansarcomagroup.org

28 sites in 10 countries

Italy9 sites, 7 recruiting

  • Istituto Ortopedico Rizzoli

    Bologna, 40136

    Alessandro Gasbarrini, MD, +390516366 ext. 066, alessandro.gasbarrini@ior.it

    Alessandro Gasbarrini, MD

    Recruiting

  • Azienda Ospedaliero-Universitaria Careggi

    Florence, 50134

    Domenico A Campanacci, MD

    Domenico A Campanacci, MD

    Not yet recruiting

  • Fondazione IRCCS Istituto Nazionale dei Tumori

    Milan, MI, 20133

    Alessandro Gronchi, MD, alessandro.gronchi@istitutotumori.mi.it

    Alessandro Gronchi, MD

    Recruiting

  • Istituto Clinico Humanitas

    Milan, 20089

    Ferdinando Cananzi, MD, ferdinando.cananzi@hunimed.eu

    Ferdinando Cananzi, MD

    Recruiting

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

    Milan, 20161

    Active, not recruiting

  • Centro Nazionale di Adroterapia Oncologica - CNAO

    Pavia, 27100

    Maria Rosaria Fiore, MD, MariaRosaria.Fiore@Cnao.it

    Maria Rosaria Fiore, MD

    Recruiting

  • II Clinica Universitaria Ortopedia e Traumatologia AO Pisa

    Pisa, 56124

    Lorenzo Andreani, MD, lorenzo.andreani.unipi@gmail.com

    Lorenzo Andreani, MD

    Recruiting

  • Istituto Regina Elena - IFO

    Rome, 00100

    Maria Grazia Petrongari, MD, +39065266 ext. 6894, mariagrazia.petrongari@ifo.gov.it

    Maria Grazia Petrongari, MD

    Recruiting

  • Agenzia Provinciale per la Protonterapia - AtreP

    Trento, 38122

    Active, not recruiting

Other trials in Italy

Spain5 sites, 4 recruiting

  • H. Val D'Hebron

    Barcelona

    Ramona V. Capdevila, MD

    Ramona V. Capdevila, MD

    Recruiting

  • Hosptial San Pau

    Barcelona

    Active, not recruiting

  • H. San Carlos

    Madrid

    Gloria M. Ospina, MD

    Gloria M. Ospina

    Not yet recruiting

  • Hospital Universitario Virgen del Rocío

    Seville

    Nadia Hindi, MD

    Nadia Hindi, MD

    Recruiting

  • Hospital Universitario Doctor Peset

    Valencia, 46017

    Antonio M. Benlloch, MD, antonio.martin@uv.es

    Antonio M. Benlloch, MD

    Not yet recruiting

Other trials in Spain

Germany4 sites, 4 recruiting

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

    Dresden

    Mechthild Krause, Prof/MD

    Mechthild Krause, Prof/MD

    Not yet recruiting

  • University Hospital Carl Gustav Carus Dresden

    Dresden

    Mechthild Krause, MD

    Mechthild Krause, MD

    Not yet recruiting

  • University Hospital Essen. West German Proton Therapy Center Essen

    Essen

    Beate Timmermann, MD

    Beate Timmermann, MD

    Recruiting

  • Heidelberg Ion-Beam Therapy Center - HIT

    Heidelberg

    Matthias Uhl, MD

    Matthias Uhl, MD

    Not yet recruiting

Other trials in Germany

Austria2 sites, 2 recruiting

  • Medical University of Graz

    Graz

    Andreas Leithner, MD

    Andreas Leithner, MD

    Recruiting

  • EBG GmbH MedAustron

    Wiener Neustadt, Österreich, 2700

    Piero Fossati, MD, +43 2622 26100 ext. 408, piero.fossati@medaustron.at

    Recruiting

Other trials in Austria

Netherlands2 sites, 2 recruiting

  • Netherlands Cancer Institute

    Amsterdam

    R LM Haas, MD

    R LM Haas, MD

    Not yet recruiting

  • Leiden University Medical Center

    Leiden

    Sander Dijkstra, MD

    Sander Dijkstra, MD

    Not yet recruiting

Other trials in Netherlands

United Kingdom2 sites, 2 recruiting

  • The Royal Orthopaedic Hospital

    Birmingham

    Lee Jeys, MD

    Lee Jeys, MD

    Not yet recruiting

  • Royal National Orthopaedic Hospital

    London

    Rob Pollock, MD

    Rob Pollock, MD

    Not yet recruiting

Other trials in United Kingdom

Hungary1 site, 1 recruiting

  • National Center for Spinal Disorders

    Budapest

    Peter P Varga, MD

    Peter P Varga, MD

    Not yet recruiting

Other trials in Hungary

Japan1 site, 1 recruiting

  • Saitama Medical Center

    Saitama

    Toru Akiyama, MD

    Toru Akiyama, MD

    Recruiting

Other trials in Japan

Norway1 site, 1 recruiting

  • Norwegian Radium Hospital/Oslo Univeristi Hospital

    Oslo, N-0424

    Øyvind S. Bruland, MD, +47 22 93 47 ext. 67, osb@ous-hf.no

    Øyvind S. Bruland, MD

    Recruiting

Other trials in Norway

Poland1 site

  • Centrum Onkologii-Instytut im. Marii Skłodowskiej-Curie

    Warsaw

    Active, not recruiting

Other trials in Poland

About this study

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

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

Read the 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

Conditions
Chordoma
Being tested
Randomized Cohort, Prospective cohort
Medical subject headings
Chordoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Randomized CohortOther

    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 cohortRadiation

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

Study groups in NCT02986516
Study groupRoleWhat they receive
Randomized CohortExperimentalParticipants who will decided to undergo to randomization, will receive surgical treatment or definitive radiotherapy according with randomization assignment
Receives: Other: Randomized Cohort
Prospective CohortActive comparatorParticipants who will not decide to be randomized, will received the surgical or definite radiotherapy treatment according to their choice
Receives: Radiation: Prospective cohort

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 5 years

Secondary outcomes (9)

  1. Overall Survival (OS)

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

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

  2. 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

    Measured: Expected average: 36 months

  3. Local Relapse Failure (LRF)

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

    Measured: Expected average: 60 months

  4. Distant Relapse Failure (DRF)

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

    Measured: Expected average: 60 months

  5. Best Response rate to definitive radiotherapy

    Best Response rate to definitive radiotherapy

    Measured: At 12 months, 2 years and 5 years after radiotherapy

  6. Time to best response rate to definitive radiotherapy

    Time to best response rate to definitive radiotherapy

    Measured: At 12 months, 2 years and 5 years after radiotherapy

  7. Adverse Events Incidence

    Adverse Events incidence

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

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

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

    Measured: every 6 months (expected average: 5 years)

  9. Evaluation of quality of life measured with Brief Inventory Pain questionnaires

    Evaluation of quality of life measured with Brief Inventory Pain questionnaires

    Measured: every 6 months (expected average: 5 years)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Dec 2016 (estimated)
  2. Study start16 Mar 2017
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02986516
Sponsor's protocol ID
ISG SACRO
Acronym
SACRO
Status last verified
Dec 2025
First submitted
2 Dec 2016
Last updated
2 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 25454979

  • 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.

    PubMed 18301055

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

    PubMed 7610417

  • 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.

    PubMed 16538613

  • 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.

    PubMed 10861454

  • 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.

    PubMed 11452362

  • 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.

    PubMed 15236319

  • 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.

    PubMed 1233436

  • 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.

    PubMed 19801981

  • 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.

    PubMed 18641983

  • 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.

    PubMed 18820665

  • 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.

    PubMed 22300861

  • 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.

    PubMed 25638683

  • 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.

    PubMed 24469886

  • 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.

    PubMed 22038441

Questions about this trial

What is this clinical trial studying?

A study testing Randomized Cohort and Prospective cohort in people with Chordoma, run by Italian Sarcoma Group at 28 sites in 10 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 2 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 28 sites in Italy, Spain, Germany, Austria, Netherlands and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Alessandro Gronchi, MD (+390223903714, alessandro.gronchi@istitutotumori.mi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Relapse Free Survival (RFS) (time frame: 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02986516, which also lists 48 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jan 2026.

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