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Recruiting nowN/AAges 18 Years to 80 Years

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

Sponsor: Italian Sarcoma Group · NCT02986516 on ClinicalTrials.gov ↗

Conditions studied

Chordoma

What it tests

  • Randomized Cohortother
  • Prospective cohortradiation

Where it's running28 sites

28 international sites
  • Medical University of Graz

    Graz, Austria

    Recruiting now
    • Andreas Leithner, MD(contact)
    • Andreas Leithner, MD(principal investigator)
  • EBG GmbH MedAustron

    Wiener Neustadt, Österreich, Austria 2700

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

    Dresden, Germany

    Opening soon
    • Mechthild Krause, Prof/MD(contact)
    • Mechthild Krause, Prof/MD(principal investigator)
  • University Hospital Carl Gustav Carus Dresden

    Dresden, Germany

    Opening soon
    • Mechthild Krause, MD(contact)
    • Mechthild Krause, MD(principal investigator)
  • University Hospital Essen. West German Proton Therapy Center Essen

    Essen, Germany

    Recruiting now
    • Beate Timmermann, MD(contact)
    • Beate Timmermann, MD(principal investigator)
  • Heidelberg Ion-Beam Therapy Center - HIT

    Heidelberg, Germany

    Opening soon
    • Matthias Uhl, MD(contact)
    • Matthias Uhl, MD(principal investigator)
  • National Center for Spinal Disorders

    Budapest, Hungary

    Opening soon
    • Peter P Varga, MD(contact)
    • Peter P Varga, MD(principal investigator)
  • Fondazione IRCCS Istituto Nazionale dei Tumori

    Milan, MI, Italy 20133

    Recruiting now
    • Alessandro Gronchi, MD(contact)[email protected]
    • Alessandro Gronchi, MD(principal investigator)
  • Istituto Ortopedico Rizzoli

    Bologna, Italy 40136

    Recruiting now
  • Azienda Ospedaliero-Universitaria Careggi

    Florence, Italy 50134

    Opening soon
    • Domenico A Campanacci, MD(contact)
    • Domenico A Campanacci, MD(principal investigator)
  • Istituto Clinico Humanitas

    Milan, Italy 20089

    Recruiting now
    • Ferdinando Cananzi, MD(contact)[email protected]
    • Ferdinando Cananzi, MD(principal investigator)
  • I.R.C.C.S. Istituto Ortopedico Galeazzi

    Milan, Italy 20161

    Active, not recruiting
  • Centro Nazionale di Adroterapia Oncologica - CNAO

    Pavia, Italy 27100

    Recruiting now
    • Maria Rosaria Fiore, MD(contact)[email protected]
    • Maria Rosaria Fiore, MD(principal investigator)
  • II Clinica Universitaria Ortopedia e Traumatologia AO Pisa

    Pisa, Italy 56124

    Recruiting now
    • Lorenzo Andreani, MD(contact)[email protected]
    • Lorenzo Andreani, MD(principal investigator)
  • Istituto Regina Elena - IFO

    Rome, Italy 00100

    Recruiting now
  • Agenzia Provinciale per la Protonterapia - AtreP

    Trento, Italy 38122

    Active, not recruiting
  • Saitama Medical Center

    Saitama, Japan

    Recruiting now
    • Toru Akiyama, MD(contact)
    • Toru Akiyama, MD(principal investigator)
  • Netherlands Cancer Institute

    Amsterdam, Netherlands

    Opening soon
    • R LM Haas, MD(contact)
    • R LM Haas, MD(principal investigator)
  • Leiden University Medical Center

    Leiden, Netherlands

    Opening soon
    • Sander Dijkstra, MD(contact)
    • Sander Dijkstra, MD(principal investigator)
  • Norwegian Radium Hospital/Oslo Univeristi Hospital

    Oslo, Norway N-0424

    Recruiting now
  • Centrum Onkologii-Instytut im. Marii Skłodowskiej-Curie

    Warsaw, Poland

    Active, not recruiting
  • H. Val D'Hebron

    Barcelona, Spain

    Recruiting now
    • Ramona V. Capdevila, MD(contact)
    • Ramona V. Capdevila, MD(principal investigator)
  • Hosptial San Pau

    Barcelona, Spain

    Active, not recruiting
  • H. San Carlos

    Madrid, Spain

    Opening soon
    • Gloria M. Ospina, MD(contact)
    • Gloria M. Ospina(principal investigator)
  • Hospital Universitario Virgen del Rocío

    Seville, Spain

    Recruiting now
    • Nadia Hindi, MD(contact)
    • Nadia Hindi, MD(principal investigator)
  • Hospital Universitario Doctor Peset

    Valencia, Spain 46017

    Opening soon
    • Antonio M. Benlloch, MD(contact)[email protected]
    • Antonio M. Benlloch, MD(principal investigator)
  • The Royal Orthopaedic Hospital

    Birmingham, United Kingdom

    Opening soon
    • Lee Jeys, MD(contact)
    • Lee Jeys, MD(principal investigator)
  • Royal National Orthopaedic Hospital

    London, United Kingdom

    Opening soon
    • Rob Pollock, MD(contact)
    • Rob Pollock, MD(principal investigator)
See the official eligibility language

Shown exactly as written on ClinicalTrials.gov. Your oncologist is the right person to judge whether it fits your situation.

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

Updated 2026-01-02 on ClinicalTrials.gov. Always confirm current details with the study team or your oncologist.