A Precision Medicine Trial Using Blood-Based Tumor Genomics to Improve Treatment in Operable Stage III and High-Risk Stage II Colon Cancer Patients

What this Trial Is About

Colon cancer is a leading cause of cancer deaths, with many patients facing recurrence after surgery, especially in stage II high-risk and stage III cases. This research aims to evaluate whether using liquid biopsy to detect cancer DNA after surgery and tailoring treatments based on tumor genetics can improve outcomes and quality of life compared to standard chemotherapy. The study includes 700 patients with operable stage III and high-risk stage II colon cancer and is designed as a randomized phase III trial to test these approaches. Patients are divided into groups based on liquid biopsy results. Those with positive results are randomized to receive either standard chemotherapy regimens (CAPOX or FOLFOX) or personalized treatments including chemotherapy combinations, immunotherapy with nivolumab and ipilimumab, or targeted therapies such as trastuzumab, pertuzumab, and panitumumab. Patients with negative liquid biopsy results are randomized to either standard chemotherapy or close monitoring with follow-ups, starting treatment if cancer DNA reappears. Treatments are adjusted based on ongoing liquid biopsy monitoring. Participants will undergo regular clinical evaluations, imaging, and complete questionnaires to assess disease recurrence, survival, safety, tolerability, and quality of life. The primary outcome is recurrence-free survival measured two years after surgery, with secondary outcomes including survival at three and five years and accuracy of liquid biopsy in detecting residual disease. The study lasts five years and involves multiple hospitals across Europe, with continuous monitoring to guide treatment decisions and assess patient well-being.

The Sagittarius Trial