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 colorectal cancer.

Intervention/Treatment

• Local ablative therapy, potentially including:
  • Surgical resection.
  • 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 surgery.
2. Primary tumour must be controlled if the primary is intact, with no evidence of progression at primary site prior to study entry.
3. Imaging 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 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 node stations.
5. All lesions can be safely treated by LAT as determined by multidisciplinary team meeting.