SYNCOPE

SYNCOPE (NCT04842006) is a multicentre randomized clinical trial investigating an intensified, precision-guided treatment strategy for patients with high-risk, locally advanced rectal cancer with MRI-detected extramural venous invasion (mrEMVI+), a group at particularly high risk of developing distant metastases. Patients are randomized to either conventional chemoradiotherapy or an experimental strategy combining short-course radiotherapy followed by total neoadjuvant CAPOX chemotherapy before surgery. In the experimental arm, postoperative treatment decisions are further guided by circulating tumor DNA (ctDNA) as a marker of minimal residual disease and by molecular and patient-derived organoid analyses. The primary objective is to determine whether this strategy improves recurrence-free survival, particularly by reducing distant metastatic recurrence. The trial also evaluates ctDNA for detection of residual disease and patient-derived tumor organoids as tools for predicting individual treatment response, aiming to develop a more personalized approach to perioperative rectal cancer therapy.

• Duration: 10 years
• Role: Coordinating PI