RESOLUTE Trial Aims to Investigate the Value of Adding Local Ablative Treatment to Standard Systemic Treatment for Unresectable Oligometastatic Colorectal Cancer — RESOLUTE  

Colorectal Cancer Clinical Trial

Official title: Randomised Phase II Trial to Evaluate Progression-Free Survival in Integrating Local Ablative Therapy With First-Line Systemic Treatment for Unresectable Oligometastatic Colorectal Cancer

Status Recruiting

Clinical Trial Summary

This study aims to assess the clinical benefit of local ablative therapy (LAT) following initial standard first-line systemic treatment including the impact on survival, compared to continued standard first-line systemic treatment for oligometastatic colorectal cancer.

Clinical Trial Description

Who is this study for:

Adults with unresectable oligo-metastatic colorectal who have demonstrated treatment benefit (partial response or stable disease as per RECIST criteria) after 3-4 months of standard first-line systemic treatment.

Study details

Participants will be randomly allocated to either a LAT arm, who will receive metastasis-directed LAT such as radiotherapy or thermal ablation following initial standard first-line systemic treatment, or a control arm who will receive continued first-line systemic treatment alone. Those receiving LAT will return to systemic treatment 16 weeks post-randomisation. Information on progression-free survival and treatment outcomes will be collected.

Data from this study will inform investigators of the potential benefit of local ablative therapy in the therapeutic setting for metastatic colorectal cancer. ;

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms
• Oligometastatic Disease

• NCT number: NCT05862051
• Study type: Interventional
• Source: Australasian Gastro-Intestinal Trials Group
• Contact: Sukanya Sathyamurthie
• Phone: +61 2 7208 2719
• Email: sukanya@gicancer.org.au
• Status: Recruiting
• Phase: N/A
• Start date: December 14, 2021
• Completion date: June 14, 2025