RESOLUTE: Randomised Phase II Trial to Evaluate the Strategy of Integrating Local Ablative Therapy with First-Line Systemic Treatment for Unresectable Oligometastatic Colorectal Cancer

Systemic treatment is the standard of care (SOC) for most patients with metastatic colorectal cancer (mCRC), and although chemotherapy can improve survival, it is never curative. The oligometastatic state is a distinct clinical scenario where a cancer has spread beyond the site of the primary tumour but there are only a limited number of metastatic deposits. The reported long-term survival after surgical resection of CRC liver-only oligometastatic disease (OMD) suggests that metastases-directed local ablative therapies (LAT) can be curative in some patients with OMD.

For the majority of mCRC patients with unresectable OMD, advances in systemic therapies and non-surgical ablative approaches (e.g. stereotactic ablative body radiotherapy) which can effectively ablate localised metastases, have created a novel therapeutic opportunity to achieve sustained disease control or even cure.

RESOLUTE aims to assess the clinical benefit of local ablative therapy (LAT) following initial standard first-line systemic treatment, compared to continued standard first-line systemic treatment in patients with unresectable oligometastatic colorectal cancer (CRC).