A Phase II Trial to Evaluate Progression-Free Survival in Integrating Local Ablative Therapy with First-Line Systemic Treatment for Unresectable Oligometastatic Colorectal Cancer

ACTRN 12621001198819

Brief Summary

This study aims to assess the clinical benefit of local ablative therapy (LAT) following initial standard first-line systemic treatment for metastatic colorectalrelating to the colon or rectum in the large bowel/intestine cancera disease where abnormal cells split without control and spread to other nearby body tissue and/or organs.

Intervention/Treatment

• Local ablative therapy, potentially including:
  • Surgical resectionsurgical removal of tissue or part/all of an organ.
  • Stereotactic radiotherapy.
  • Laproscopic or percutaneous thermal ablation (radiofrequency ablation (RFA)a minimally invasive procedure that uses heat to destroy abnormal tissue and/or cancer cells or microwave ablation (MWA)).

Inclusion Criteria

1. Metastatic colorectal adenocarcinomacancer arising from mucus-producing glands in organs that is not amenable to potentially curative surgerytreatment involving removal of cancerous tissue and/or tumours and a margin of healthy tissue around it to reduce recurrence.
2. Primary tumoura tissue mass that forms from groups of unhealthy cells must be controlled if the primary is intact, with no evidence of progression at primary site prior to study entry.
3. Imagingtests that create detailed images of areas inside the body demonstrating ongoing treatment benefit (partial response or stable disease as per RECIST criteria) after 3-6 months of standard first-line systemic treatment.
4. 3 to 10 metastatic lesions detected on CT +/- FDG-PET scan prior to first line systemic treatment AND on screeningtesting for cancer or conditions that can lead to cancer before symptoms appear, also known as cancer screening FDG-PET and CT scans:
   • maximum of 3 lesions per organ except for the liver and lung.
   • maximum of 5 lesions in the lung.
   • no limit to number of liver lesions provided all are amenable to LAT.
   • maximum of 3 involved organs including a maximum of 2 lymph nodea small lump or mass of tissue in your body stations.
5. All lesions can be safely treated by LAT as determined by multidisciplinary teama team of health specialists such as medical oncologists, surgical oncologists, radiation oncologists, nurses, allied health and pharmacists who work together to treat patients meeting.