This study is being done to compare the outcomes and safety of two standard treatment options called microwave ablation and surgical wedge resection in patients with lung lesions that are suspicious for or known to be non-small cell lung cancer or sarcoma and colorectal cancer that has spread to other parts of the body (metastatic). Microwave ablation is designed to kill tumor cells by heating the tumor until the tumor cells die. A wedge resection is a procedure that involves the surgical removal of a small, wedge-shaped piece of lung tissue to remove a small tumor or to diagnose lung cancer. Comparing these two treatment options may help researchers learn which method works better for the treatment of patients with lung lesions that are suspicious for or known to be non-small cell lung cancer, metastatic sarcoma, and metastatic colorectal cancer.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04430725.
PRIMARY OBJECTIVE:
I. Estimate the 2-year local recurrence rate for microwave ablation within each basket.
SECONDARY OBJECTIVE:
I. Evaluate whether microwave ablation offers treatment benefit for safety, efficacy, or changes in patient reported outcomes when compared to wedge resection using a contemporaneous database consisting of a commensurate surgical patient population.
OUTLINE: This is an observational study.
Patients undergo computed tomography (CT) and may undergo magnetic resonance imaging (MRI) as clinically indicated during screening. Patients undergo standard care microwave ablation or wedge resection on study. Patients may undergo biopsy as clinically indicated and complete questionnaires throughout the study. Patients also undergo contrast-enhanced CT or positron emission tomography (PET)/CT during follow up.
Trial PhaseNo phase specified
Trial TypeNot provided by clinicaltrials.gov
Lead OrganizationM D Anderson Cancer Center
Principal InvestigatorWayne Lewis Hofstetter
