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

What this Trial Is About

Researchers are comparing surgery and definitive radiation therapy for patients with primary localized sacral chordoma, a rare type of cancer occurring in the sacrum area. This international, multicenter study includes both randomized and observational components to evaluate these treatments. The study aims to understand which approach offers better control of the disease and longer relapse-free survival over five years. Participants may be randomly assigned to receive either surgical treatment (with or without radiation) or definitive high-dose radiation therapy such as carbon ion radiotherapy, proton therapy, or mixed photon-proton therapy. Those who opt out of randomization can choose their treatment and still be followed in the prospective cohort group. Both groups receive the same radiation and surgical regimens as part of their treatment plans. During the study, participants will undergo regular assessments including MRI or CT scans to monitor the tumor, evaluations of overall survival, relapse events, response to radiation, side effects, and quality of life using specific questionnaires every six months for up to five years. Safety and treatment effects will be closely monitored throughout the study period, which may extend up to ten years for survival follow-up.

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