NCT02986516

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

Title of Study: SAcral Chordoma: a Randomized & Observational Study on Surgery Versus Definitive Radiation Therapy in Primary Localized Disease (SACRO)

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Italian Sarcoma Group · Network
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

International, multicenter, comparative, open-label, parallel-group, mixed Observational-Randomized Controlled Trial. All the patients, who are candidate for the study will receive full information on the characteristics, potential effectiveness and side effects of the two alternatives treatments: radiotherapy (RT) and surgical treatment Eligible patients will be asked to be randomized in order to receive treatment A (surgery, with or without RT) or treatment B (definitive RT) Who will refuse randomization will be included in the Prospective Cohort Study (PCS) and will be treated accordingly to their choice (treatment option A or treatment option B). The same radiotherapy and surgical regimen will be administered in the PCS and in the Randomized Clinical Trial (RCT) cohort

Conditions

• Chordoma

Interventions

Type	Name	Description
OTHER	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
RADIATION	Prospective cohort	Surgical treatment or definitive high dose radiotherapy will be selected by the patients and will be prospectively evaluated

Timeline

• Start date: 2017-03-16
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2016-12-08
• Last updated: 2026-01-02

Locations

28 sites across 10 countries: Austria, Germany, Hungary, Italy, Japan, Netherlands, Norway, Poland, Spain, United Kingdom