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

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 colorectal cancer.

Intervention / Treatment 

  • ProcedureLocal Ablative Therapy
  • ProcedureStandard first-line systemic treatment

Inclusion Criteria:

  • 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:
    1. max of 3 lesions per organ except for the liver and lung
    2. max of 5 lesions in the lung
    3. no limitation to the number of liver lesions provided they are all amenable to LAT
    4. max of 3 involved organs including a lymph node station
    5. only one lymph node station involvement is allowed
    6. 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
    7. 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.

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