Sacral Chordoma: Surgery Versus Definitive Radiation Therapy in Primary Localized Disease
Sponsor: Italian Sarcoma Group · NCT02986516 on ClinicalTrials.gov ↗
Conditions studied
What it tests
- Randomized Cohortother
- Prospective cohortradiation
Where it's running28 sites
28 international sites
- Recruiting now
Medical University of Graz
Graz, Austria
- Andreas Leithner, MD(contact)
- Andreas Leithner, MD(principal investigator)
- Recruiting now
EBG GmbH MedAustron
Wiener Neustadt, Österreich, Austria 2700
- Piero Fossati, MD(contact)+43 2622 26100[email protected]
- Opening soon
Medical Faculty Carl Gustav Carus Faculty of Medicine, Department of Radiation Oncology,
Dresden, Germany
- Mechthild Krause, Prof/MD(contact)
- Mechthild Krause, Prof/MD(principal investigator)
- Opening soon
University Hospital Carl Gustav Carus Dresden
Dresden, Germany
- Mechthild Krause, MD(contact)
- Mechthild Krause, MD(principal investigator)
- Recruiting now
University Hospital Essen. West German Proton Therapy Center Essen
Essen, Germany
- Beate Timmermann, MD(contact)
- Beate Timmermann, MD(principal investigator)
- Opening soon
Heidelberg Ion-Beam Therapy Center - HIT
Heidelberg, Germany
- Matthias Uhl, MD(contact)
- Matthias Uhl, MD(principal investigator)
- Opening soon
National Center for Spinal Disorders
Budapest, Hungary
- Peter P Varga, MD(contact)
- Peter P Varga, MD(principal investigator)
- Recruiting now
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, MI, Italy 20133
- Alessandro Gronchi, MD(contact)[email protected]
- Alessandro Gronchi, MD(principal investigator)
- Recruiting now
Istituto Ortopedico Rizzoli
Bologna, Italy 40136
- Alessandro Gasbarrini, MD(contact)+390516366[email protected]
- Alessandro Gasbarrini, MD(principal investigator)
- Opening soon
Azienda Ospedaliero-Universitaria Careggi
Florence, Italy 50134
- Domenico A Campanacci, MD(contact)
- Domenico A Campanacci, MD(principal investigator)
- Recruiting now
Istituto Clinico Humanitas
Milan, Italy 20089
- Ferdinando Cananzi, MD(contact)[email protected]
- Ferdinando Cananzi, MD(principal investigator)
- Active, not recruiting
I.R.C.C.S. Istituto Ortopedico Galeazzi
Milan, Italy 20161
- Recruiting now
Centro Nazionale di Adroterapia Oncologica - CNAO
Pavia, Italy 27100
- Maria Rosaria Fiore, MD(contact)[email protected]
- Maria Rosaria Fiore, MD(principal investigator)
- Recruiting now
II Clinica Universitaria Ortopedia e Traumatologia AO Pisa
Pisa, Italy 56124
- Lorenzo Andreani, MD(contact)[email protected]
- Lorenzo Andreani, MD(principal investigator)
- Recruiting now
Istituto Regina Elena - IFO
Rome, Italy 00100
- Maria Grazia Petrongari, MD(contact)+39065266[email protected]
- Maria Grazia Petrongari, MD(principal investigator)
- Active, not recruiting
Agenzia Provinciale per la Protonterapia - AtreP
Trento, Italy 38122
- Recruiting now
Saitama Medical Center
Saitama, Japan
- Toru Akiyama, MD(contact)
- Toru Akiyama, MD(principal investigator)
- Opening soon
Netherlands Cancer Institute
Amsterdam, Netherlands
- R LM Haas, MD(contact)
- R LM Haas, MD(principal investigator)
- Opening soon
Leiden University Medical Center
Leiden, Netherlands
- Sander Dijkstra, MD(contact)
- Sander Dijkstra, MD(principal investigator)
- Recruiting now
Norwegian Radium Hospital/Oslo Univeristi Hospital
Oslo, Norway N-0424
- Øyvind S. Bruland, MD(contact)+47 22 93 47[email protected]
- Øyvind S. Bruland, MD(contact)
- Active, not recruiting
Centrum Onkologii-Instytut im. Marii Skłodowskiej-Curie
Warsaw, Poland
- Recruiting now
H. Val D'Hebron
Barcelona, Spain
- Ramona V. Capdevila, MD(contact)
- Ramona V. Capdevila, MD(principal investigator)
- Active, not recruiting
Hosptial San Pau
Barcelona, Spain
- Opening soon
H. San Carlos
Madrid, Spain
- Gloria M. Ospina, MD(contact)
- Gloria M. Ospina(principal investigator)
- Recruiting now
Hospital Universitario Virgen del Rocío
Seville, Spain
- Nadia Hindi, MD(contact)
- Nadia Hindi, MD(principal investigator)
- Opening soon
Hospital Universitario Doctor Peset
Valencia, Spain 46017
- Antonio M. Benlloch, MD(contact)[email protected]
- Antonio M. Benlloch, MD(principal investigator)
- Opening soon
The Royal Orthopaedic Hospital
Birmingham, United Kingdom
- Lee Jeys, MD(contact)
- Lee Jeys, MD(principal investigator)
- Opening soon
Royal National Orthopaedic Hospital
London, United Kingdom
- 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.