Ireland
--:--IST
Recruiting Not applicable

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

NCT02986516 · tracked via the Priya Life Science Spain tracker
Phase
Not applicable
Started
2017-03-16
Last updated
2026-01-02

Condition(s) studied

Chordoma

Investigational drug(s) / intervention(s)

Randomized CohortProspective cohort

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

Study summary

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • Relapse Free Survival (RFS) — 5 years
    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.

Trial sites (28)

FacilityCityRegionStatus
Medical University of Graz Graz Austria Recruiting
EBG GmbH MedAustron Wiener Neustadt Österreich Recruiting
Medical Faculty Carl Gustav Carus Faculty of Medicine, Department of Radiation Oncology, Dresden Germany Not Yet Recruiting
University Hospital Carl Gustav Carus Dresden Dresden Germany Not Yet Recruiting
University Hospital Essen. West German Proton Therapy Center Essen Essen Germany Recruiting
Heidelberg Ion-Beam Therapy Center - HIT Heidelberg Germany Not Yet Recruiting
National Center for Spinal Disorders Budapest Hungary Not Yet Recruiting
Fondazione IRCCS Istituto Nazionale dei Tumori Milan MI Recruiting
Istituto Ortopedico Rizzoli Bologna Italy Recruiting
Azienda Ospedaliero-Universitaria Careggi Florence Italy Not Yet Recruiting
Istituto Clinico Humanitas Milan Italy Recruiting
I.R.C.C.S. Istituto Ortopedico Galeazzi Milan Italy Active Not Recruiting
Centro Nazionale di Adroterapia Oncologica - CNAO Pavia Italy Recruiting
II Clinica Universitaria Ortopedia e Traumatologia AO Pisa Pisa Italy Recruiting
Istituto Regina Elena - IFO Rome Italy Recruiting
Agenzia Provinciale per la Protonterapia - AtreP Trento Italy Active Not Recruiting
Saitama Medical Center Saitama Japan Recruiting
Netherlands Cancer Institute Amsterdam Netherlands Not Yet Recruiting
Leiden University Medical Center Leiden Netherlands Not Yet Recruiting
Norwegian Radium Hospital/Oslo Univeristi Hospital Oslo Norway Recruiting
Centrum Onkologii-Instytut im. Marii Skłodowskiej-Curie Warsaw Poland Active Not Recruiting
H. Val D'Hebron Barcelona Spain Recruiting
Hosptial San Pau Barcelona Spain Active Not Recruiting
H. San Carlos Madrid Spain Not Yet Recruiting
Hospital Universitario Virgen del Rocío Seville Spain Recruiting
Hospital Universitario Doctor Peset Valencia Spain Not Yet Recruiting
The Royal Orthopaedic Hospital Birmingham United Kingdom Not Yet Recruiting
Royal National Orthopaedic Hospital London United Kingdom Not Yet Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT02986516 on ClinicalTrials.gov ↗ ← All trials in Spain