Lung Cancer Clinical Trial
Microwave Ablation or Wedge Resection for the Treatment of Lung, Sarcoma and Colorectal Lesions, ALLUME Study
Summary
This study compares the outcomes and safety of two standard treatment options called microwave ablation and surgical wedge resection in patients with non-small cell lung cancer, 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 non-small cell lung cancer, metastatic sarcoma, and metastatic colorectal cancer.
Full Description
PRIMARY OBJECTIVE:
I. Estimate the 2-year local recurrence rate for microwave ablation within a basket.
SECONDARY OBJECTIVES:
I. Evaluate whether microwave ablation offers treatment benefit for safety when compared to wedge resection using a contemporaneous database consisting of a commensurate surgical patient population.
II. Evaluate whether microwave ablation offers treatment benefit for efficacy when compared to wedge resection using a contemporaneous database consisting of a commensurate surgical patient population.
III. Evaluate whether microwave ablation offers treatment benefit for changes in patient reported outcomes when compared to wedge resection using a contemporaneous database consisting of a commensurate surgical patient population.
OUTLINE:
Patients undergo standard care microwave ablation or wedge resection followed by contrast-enhanced computed tomography (CT) imaging at 1, 6, 12, 18 and 24 months. Patients also complete questionnaires over 10-15 minutes at baseline up to 9 months.
Eligibility Criteria
Inclusion Criteria:
Patient has a lung lesion(s) that is either biopsy-proven cancer or shows sequential growth on CT imaging with clinical suspicion for non-small cell lung cancer (NSCLC)-stage I; NSCLC-stage > 1; metastatic sarcoma; or metastatic colorectal (CRC) cancer
3 cm or less tumor size
Other sites for cancer are either controlled or there are plans for control
Expected margin at least 1 cm from critical structures, allowing for protective strategies such as induction of therapeutic pneumothorax. Critical structures include the trachea, main bronchi, esophagus, aorta, aortic arch branches, superior vena cava (SVC), main, right or left pulmonary artery, or heart.
Exclusion Criteria:
Patient is considered high risk for ablation due to major comorbid medical conditions
Patient is pregnant or breast feeding
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There is 1 Location for this study
Houston Texas, 77030, United States More Info
Principal Investigator
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