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

RecruitingNAAges 18 Years - 80 YearsAllItalian Sarcoma Group
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In plain words

What the trial is, and whether it could suit you

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

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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
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What it tests

  • Randomized Cohort
  • Prospective cohort
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Where

28 sites
Medical University of Graz
Graz, Austria
EBG GmbH MedAustron
Wiener Neustadt, Austria
Medical Faculty Carl Gustav Carus Faculty of Medicine, Department of Radiation Oncology,
Dresden, Germany
University Hospital Carl Gustav Carus Dresden
Dresden, Germany
University Hospital Essen. West German Proton Therapy Center Essen
Essen, Germany
Heidelberg Ion-Beam Therapy Center - HIT
Heidelberg, Germany
National Center for Spinal Disorders
Budapest, Hungary
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, Italy

…and 20 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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