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Spinal tumor showdown: surgery vs. radiation in new trial

NCT ID NCT02986516

Disease control Sponsor: Italian Sarcoma Group Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study compares two standard treatments for a rare spinal tumor called sacral chordoma: surgery and radiation therapy. Researchers want to see which approach better prevents the tumor from coming back. About 100 adults with newly diagnosed, localized chordoma will take part.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 100 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2017

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

A research network

The lead sponsor is a research network or cooperative group.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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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Conditions

The condition(s) this trial relates to.

chordoma sacrum chordoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Chordoma

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    24 sites in 9 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Agenzia Provinciale per la Protonterapia - AtreP

    ACTIVE_NOT_RECRUITING

    Trento, 38122, Italy

  • Azienda Ospedaliero-Universitaria Careggi

    NOT_YET_RECRUITING

    Florence, 50134, Italy

  • Centro Nazionale di Adroterapia Oncologica - CNAO

    RECRUITING

    Pavia, 27100, Italy

  • Centrum Onkologii-Instytut im. Marii Skłodowskiej-Curie

    ACTIVE_NOT_RECRUITING

    Warsaw, Poland

  • EBG GmbH MedAustron

    RECRUITING

    Wiener Neustadt, Österreich, 2700, Austria

  • Fondazione IRCCS Istituto Nazionale dei Tumori

    RECRUITING

    Milan, MI, 20133, Italy

  • H. San Carlos

    NOT_YET_RECRUITING

    Madrid, Spain

  • H. Val D'Hebron

    RECRUITING

    Barcelona, Spain

  • Heidelberg Ion-Beam Therapy Center - HIT

    NOT_YET_RECRUITING

    Heidelberg, Germany

  • Hospital Universitario Doctor Peset

    NOT_YET_RECRUITING

    Valencia, 46017, Spain

  • Hospital Universitario Virgen del Rocío

    RECRUITING

    Seville, Spain

  • Hosptial San Pau

    ACTIVE_NOT_RECRUITING

    Barcelona, Spain

  • I.R.C.C.S. Istituto Ortopedico Galeazzi

    ACTIVE_NOT_RECRUITING

    Milan, 20161, Italy

  • II Clinica Universitaria Ortopedia e Traumatologia AO Pisa

    RECRUITING

    Pisa, 56124, Italy

  • Istituto Clinico Humanitas

    RECRUITING

    Milan, 20089, Italy

  • Istituto Ortopedico Rizzoli

    RECRUITING

    Bologna, 40136, Italy

  • Istituto Regina Elena - IFO

    RECRUITING

    Rome, 00100, Italy

  • Leiden University Medical Center

    NOT_YET_RECRUITING

    Leiden, Netherlands

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

    NOT_YET_RECRUITING

    Dresden, Germany

  • Medical University of Graz

    RECRUITING

    Graz, Austria

  • National Center for Spinal Disorders

    NOT_YET_RECRUITING

    Budapest, Hungary

  • Netherlands Cancer Institute

    NOT_YET_RECRUITING

    Amsterdam, Netherlands

  • Norwegian Radium Hospital/Oslo Univeristi Hospital

    RECRUITING

    Oslo, N-0424, Norway

  • Royal National Orthopaedic Hospital

    NOT_YET_RECRUITING

    London, United Kingdom

  • Saitama Medical Center

    RECRUITING

    Saitama, Japan

  • The Royal Orthopaedic Hospital

    NOT_YET_RECRUITING

    Birmingham, United Kingdom

  • University Hospital Carl Gustav Carus Dresden

    NOT_YET_RECRUITING

    Dresden, Germany

  • University Hospital Essen. West German Proton Therapy Center Essen

    RECRUITING

    Essen, Germany

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