Colon Cancer Clinical Trial

Tissue Analysis After Thermal Ablation for Colon Cancer Liver Metastases Leading to Immediate Retreatment

Summary

This study will see whether collecting and analyzing needle biopsy samples from colon cancer liver metastases (CLM) after a thermal 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.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Diagnosis of colorectal cancer liver metastases (CLM)
Confined liver disease or limited extrahepatic disease stable/controlled for at least 4 months (extrahepatic disease amenable to treatment is allowed)
Lesions of ≤3 cm in maximum diameter
At least one FDG-avid lesion to be treated***
Any patient with CLM treated with Microwave ablation (as per clinical IR Guidelines)*
INR < 1.5*
Platelet count ≥ 50,000

Exclusion Criteria:

Age < 18
Less than 5 mm distance to a structure (GI or biliary tract), that cannot be protected from ablation injury with technical modifications such as hydro or air dissection
INR > 1.5 that cannot be corrected with fresh frozen plasma **
Platelet count of <50,000 that cannot be corrected with transfusion
More than 3 tumors in the liver
More than 5 tumors of extrahepatic disease (including mediastinal nodes and pulmonary nodules, abdominal or other lymph nodes, and bone metastasis)

Presence of any peritoneal Carcinomatosis

Institutional IR guidelines:

https://one.mskcc.org/sites/pub/radiology/lptestapp/Split%20Dose%20PET%20Ablation%20Liver%20tumors.pdf

For patients on Coumadin, general clinical guidelines for IR ablation will be followed.

For patients with no FDG-PET avid tumors aim 2 of the protocol will not be assessed

Study is for people with:

Colon Cancer

Phase:

Phase 2

Estimated Enrollment:

100

Study ID:

NCT04143516

Recruitment Status:

Recruiting

Sponsor:

Memorial Sloan Kettering Cancer Center

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There is 1 Location for this study

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Memorial Sloan Kettering Cancer Center
New York New York, 10065, United States More Info
Constantinos Sofocleous, MD
Contact
212-639-3379
Efsevia Vakiani, MD
Contact
646-888-3060
Constantinos Sofocleous, MD
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Colon Cancer

Phase:

Phase 2

Estimated Enrollment:

100

Study ID:

NCT04143516

Recruitment Status:

Recruiting

Sponsor:


Memorial Sloan Kettering Cancer Center

How clear is this clinincal trial information?

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