Investigating local ablative treatment for colorectal cancer with metastases

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study assesses the clinical benefit of adding local ablative therapy (LAT) to standard systemic treatment for adults with unresectable oligometastatic colorectal cancer. Participants will be randomly assigned to receive either LAT following initial systemic treatment or continue with systemic treatment alone. The study aims to evaluate the impact of LAT on survival and progression-free survival compared to standard treatment. Data collected will help determine the potential advantages of incorporating LAT in the treatment regimen for this patient population.

Why it matters

Who can join: the full rules

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.

Exclusion Criteria:

* Deficient mismatch repair (dMMR) or microsatellite instability-high (MSI-high) tumour
* BRAFV600E mutated tumour
* Concurrent or previous other malignancy within 2 years of study entry, except curatively treated basal or squamous cell skin cancer, prostate intraepithelial neoplasm, carcinoma in-situ of the cervix, Bowen's disease or prostate cancer with a Gleason score ≤6.
* Presence of brain, peritoneal, omental or ovarian metastases
* Malignant pleural effusion or ascites.

Where it's running

• Border Medical Oncology
  Albury, New South Wales, Australia Recruiting
• Bendigo Hospital
  Bendigo, Victoria, Australia Recruiting
• Eastern Health
  Box Hill, Victoria, Australia Recruiting
• St Vincent's Hospital Melbourne
  Fitzroy, Victoria, Australia Recruiting
• Peter MaCallum Cancer Centre
  Melbourne, Victoria, Australia Recruiting
• Western Health
  Saint Albans, Victoria, Australia Recruiting

Study contacts

• Study coordinator: Sukanya Sathyamurthie
• Email: sukanya@gicancer.org.au
• Phone: +61 2 7208 2719

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.