Comparing surgery and radiation therapy for sacral chordoma treatment
Title of Study: SAcral Chordoma: a Randomized & Observational Study on Surgery Versus Definitive Radiation Therapy in Primary Localized Disease (SACRO)
This study is testing whether surgery or radiation therapy works better for treating sacral chordoma in patients who have this localized tumor.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Italian Sarcoma Group Research network |
| Drugs / interventions | radiation |
| Locations | 28 sites (Graz and 27 other locations) |
| Trial ID | NCT02986516 on ClinicalTrials.gov |
What this trial studies
This study compares the effectiveness of surgical treatment versus definitive radiation therapy for patients with primary localized sacral chordoma. Eligible participants will be informed about both treatment options and can choose to be randomized into either the surgical group or the radiation therapy group. Those who prefer not to be randomized will be included in a prospective cohort study where they will receive their chosen treatment. The study aims to evaluate outcomes and side effects associated with both approaches in a multicenter international setting.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a confirmed diagnosis of primary sacral chordoma who are eligible for either surgery or radiation therapy.
Not a fit: Patients with distant metastasis or those who have previously undergone treatment for sacral chordoma may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide clearer guidance on the most effective treatment for sacral chordoma, potentially improving patient outcomes.
How similar studies have performed: Previous studies have explored treatment options for chordoma, but this specific comparative approach is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Graz and 27 other locations
- Medical University of Graz — Graz, Austria (Recruiting)
- EBG GmbH MedAustron — Wiener Neustadt, Österreich, Austria (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, Italy (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)
Study contacts
- Principal investigator: Alessandro Gronchi, MD — Istituto Nazionale Tumori Milan-Italy
- Study coordinator: Alessandro Gronchi, MD
- Email: alessandro.gronchi@istitutotumori.mi.it
- Phone: +390223903714
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.