NCT 05862051
Brief 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 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
- Procedure: Local Ablative Therapy
- Procedure: Standard first-line systemic treatment
Inclusion Criteria:
- Metastatic colorectal adenocarcinomacancer arising from mucus-producing glands in organs that is not amenable to potentially oncological curative surgerytreatment involving removal of cancerous tissue and/or tumours and a margin of healthy tissue around it to reduce recurrence alone.
- 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
- Imagingtests that create detailed images of areas inside the body demonstrating ongoing treatment benefit (partial response or stable disease as per RECIST criteria) after 3-4 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 screeningtesting for cancer or conditions that can lead to cancer before symptoms appear, also known as cancer 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 nodea small lump or mass of tissue in your body 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
- stagingthe process of determining how big the cancer is, where it started and if it has spread to other areas 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 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.