200 Participants Needed

Thermal Ablation for Colon Cancer Liver Metastases

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Overseen ByEfsevia Vakiani, MD,PhD
Age: 18+
Sex: Any
Trial Phase: Phase 2 & 3
Sponsor: Memorial Sloan Kettering Cancer Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 4 JurisdictionsThis treatment is already approved in other countries

Trial Summary

What is the purpose of this trial?

This study will see whether collecting and analyzing needle biopsy samples from cancer liver metastases after a tumor ablation procedure will be able to identify cancer cells that are still alive. The results of these biopsies could help determine the next treatment for your cancer, but the biopsies could cause side effects.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are on Coumadin, general clinical guidelines for the procedure will be followed, which might involve adjustments.

What data supports the effectiveness of the treatment Thermal Ablation for Colon Cancer Liver Metastases?

Research shows that thermal ablation, including microwave ablation, is an effective treatment for patients with metastatic colon cancer to the liver, especially for those who cannot undergo surgery. It offers a potential cure for patients with multiple liver metastases, and there is growing evidence supporting its use in managing metastatic colorectal liver disease.12345

Is thermal ablation safe for treating liver metastases?

Thermal ablation techniques like microwave ablation (MWA) and radiofrequency ablation (RFA) have been studied for treating liver tumors, including those from colon cancer. While these treatments are generally considered safe, they can have complications such as incomplete tumor cell death and potential spread of cancer cells within the liver or to other parts of the body.24678

How is thermal ablation treatment different from other treatments for colon cancer liver metastases?

Thermal ablation is unique because it uses heat to destroy cancer cells in the liver, offering a treatment option for patients who cannot undergo surgery. It includes various methods like microwave and radiofrequency ablation, which can be performed percutaneously (through the skin) and may provide a curative approach for patients with non-resectable liver metastases.124910

Research Team

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Constantinos Sofocleous, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Eligibility Criteria

This trial is for people with colorectal cancer that has spread to the liver. They should have at least one lesion visible on a PET scan, a sufficient platelet count, and stable liver or limited extrahepatic disease. The study excludes those who don't meet these criteria.

Inclusion Criteria

My cancer lesion is 3 cm or smaller.
I have been diagnosed with liver metastases from colorectal cancer.
Your blood's ability to clot is not too high.
See 4 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Tumor Ablation and Biopsy

Participants undergo a standard of care tumor ablation procedure followed by post-ablation biopsies and PET scans. If PET scans are positive, additional biopsies are performed, and if cancer cells are detected, immediate retreatment with a second ablation is conducted.

4-6 weeks

Follow-up

Participants are monitored for tumor response and safety using CT and PET scans, with the first scans post-ablation serving as the new baseline for comparison.

2 years

Treatment Details

Interventions

  • Thermal ablation (TA)
Trial OverviewThe study tests if analyzing tissue samples after tumor ablation can detect living cancer cells in the liver. This could guide further treatment decisions. Participants will undergo tumor ablation followed by PET/CT scans.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Patients with Liver MetastasesExperimental Treatment3 Interventions
The standard of care tumor ablation procedure, post-ablation biopsies and pre- and post-ablation PET scans. If the PET scan is positive (shows areas of cancer in the treated metastases), study participants will undergo additional needle biopsies of the positive areas on the scan. If the biopsies show areas of cancer cells that are still alive, the participants will be immediately retreated with a second ablation procedure.

Thermal ablation (TA) is already approved in European Union, United States, Canada, Japan for the following indications:

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Approved in European Union as Thermal Ablation for:
  • Liver cancer
  • Liver metastases
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Approved in United States as Thermal Ablation for:
  • Liver cancer
  • Liver metastases
  • Hepatocellular carcinoma
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Approved in Canada as Thermal Ablation for:
  • Liver cancer
  • Liver metastases
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Approved in Japan as Thermal Ablation for:
  • Liver cancer
  • Liver metastases

Find a Clinic Near You

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials
1,998
Recruited
602,000+

Findings from Research

Colorectal cancer (CRC) is a major cause of cancer-related deaths, with liver metastases commonly present at diagnosis, making effective treatment crucial.
Thermal ablation techniques, particularly microwave ablation (MWA), are emerging as important options for managing CRC liver metastases, offering potential benefits for patients who are not candidates for surgical resection.
Thermal Ablation of Metastatic Colon Cancer to the Liver.Camacho, JC., Petre, EN., Sofocleous, CT.[2020]
In a study of 10 patients with five or more colorectal liver metastases treated with microwave ablation (MWA), the procedure demonstrated a median overall survival of 3 years and a disease-free survival of 7.1 months, indicating its efficacy even in high-volume metastatic cases.
The study reported a low per-lesion recurrence rate of 4% at the ablation site, suggesting that MWA can effectively control local disease, although intrahepatic recurrence occurred in 60% of patients, highlighting the need for careful patient selection and follow-up.
Surgical microwave ablation for multifocal non-resectable liver metastases: a single institution experience treating five or more liver lesions.Wothe, JK., McEachron, KR., Marmor, S., et al.[2022]
Percutaneous thermal ablation techniques, including radiofrequency ablation, microwave ablation, cryoablation, and MR-guided focused ultrasound, effectively reduced pain in patients with bone metastases, achieving pain relief in up to 91% of patients at 1 month and 95% at 3 months based on a review of 11 studies involving 364 patients.
Microwave ablation demonstrated a negligible complication rate, making it a safer option, while MR-guided focused ultrasound had a higher rate of complications, indicating a need for careful consideration of treatment choice based on safety profiles.
Thermal ablation to relieve pain from metastatic bone disease: a systematic review.Gennaro, N., Sconfienza, LM., Ambrogi, F., et al.[2023]

References

Thermal Ablation of Metastatic Colon Cancer to the Liver. [2020]
Surgical microwave ablation for multifocal non-resectable liver metastases: a single institution experience treating five or more liver lesions. [2022]
Thermal ablation to relieve pain from metastatic bone disease: a systematic review. [2023]
Intraoperative thermal ablation therapy for small colorectal metastases to the liver. [2008]
Predictive Factors of Local Recurrence after Colorectal Cancer Liver Metastases Thermal Ablation. [2023]
The safety and efficacy of microwave ablation for the treatment of CRC pulmonary metastases. [2019]
Image-guided microwave ablation of hepatic tumours: preliminary experience. [2021]
Complications of thermal ablation of hepatic tumours: comparison of radiofrequency and microwave ablative techniques. [2013]
Biopsy and Margins Optimize Outcomes after Thermal Ablation of Colorectal Liver Metastases. [2022]
Thermal ablation may improve outcomes in patients with colorectal liver metastasis: a case-control study. [2019]