Investigating local ablative treatment for colorectal cancer with metastases

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 is testing if adding a local treatment to regular therapy can help adults with hard-to-treat colorectal cancer live longer and have fewer problems.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 75 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Australasian Gastro-Intestinal Trials Group (network)
• Locations: 9 sites (Albury, New South Wales and 8 other locations)
• Trial ID: NCT05862051 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults with unresectable oligometastatic colorectal cancer who have shown a partial response or stable disease after initial systemic treatment.

Not a fit: Patients with resectable metastatic disease or those who have not responded to initial systemic treatment may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could improve survival outcomes for patients with oligometastatic colorectal cancer.

How similar studies have performed: Other studies have shown promising results with local ablative therapies in similar contexts, suggesting potential for success in this approach.

Eligibility criteria

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 this trial is running

Albury, New South Wales and 8 other locations

• Border Medical Oncology — Albury, New South Wales, Australia (RECRUITING)
• Bendigo Hospital — Bendigo, Victoria, Australia (RECRUITING)
• Eastern Health — Box Hill, Victoria, Australia (RECRUITING)
• The Northern Hospital — Epping, Victoria, Australia (NOT_YET_RECRUITING)
• St Vincent's Hospital Melbourne — Fitzroy, Victoria, Australia (RECRUITING)
• Peter MaCallum Cancer Centre — Melbourne, Victoria, Australia (RECRUITING)
• Peninsula Health — Rosebud, Victoria, Australia (NOT_YET_RECRUITING)
• Western Health — Saint Albans, Victoria, Australia (RECRUITING)
• Northeast Health Wangaratta — Wangaratta, Victoria, Australia (RECRUITING)

Study contacts

• Study coordinator: Sukanya Sathyamurthie

Conditions: Colorectal Cancer, Oligometastatic Disease