Randomised Phase II Trial to Evaluate Progression-Free Survival in Integrating Local Ablative Therapy With First-Line Systemic Treatment for Unresectable Oligometastatic Colorectal Cancer
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.
• Metastatic colorectal adenocarcinoma that is not amenable to potentially oncological curative surgery alone.
• Primary tumour must be controlled if the primary is intact, with no evidence of progression at primary site prior to study entry
• Imaging demonstrating ongoing treatment benefit (partial response or stable disease as per RECIST criteria) after 3-4 months of standard first-line systemic treatment.
• At least one metastatic lesion detected on CT +/- FDG-PET scan prior to first line systemic treatment AND on screening FDG-PET and CT scans, meeting the following criteria:
‣ max of 3 lesions per organ except for the liver and lung
⁃ max of 5 lesions in the lung
⁃ no limitation to the number of liver lesions provided they are all amenable to LAT
⁃ max of 3 involved organs including a lymph node station
⁃ only one lymph node station involvement is allowed
⁃ for patients with liver metastases, a quadruple phase contrast enhanced CT or MRI liver is required to fully stage the liver; this can be performed prior to or within 4 weeks of commencing first line systemic treatment
⁃ staging FDG-PET scan is encouraged and can be performed prior to or within 4 weeks of commencing first line systemic treatment
• All lesions can be safely treated by LAT as determined by multidisciplinary team meeting.