Comparing surgery and radiation therapy for sacral chordoma treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Medical University of Graz
  Graz, Austria Recruiting
• EBG GmbH MedAustron
  Wiener Neustadt, Österreich, Austria Recruiting
• University Hospital Essen. West German Proton Therapy Center Essen
  Essen, Germany Recruiting
• Fondazione IRCCS Istituto Nazionale dei Tumori
  Milan, Mi, Italy Recruiting
• Istituto Ortopedico Rizzoli
  Bologna, Italy Recruiting
• Istituto Clinico Humanitas
  Milan, Italy 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.