Stage IV Lung Cancer AJCC v8 Clinical Trial
Official title:
Ablation of Lung Lesions Using Microwave Energy (ALLUME)
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.
Status | Recruiting |
Enrollment | 120 |
Est. completion date | January 1, 2026 |
Est. primary completion date | January 1, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | M D Anderson Cancer Center | Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
M.D. Anderson Cancer Center | National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Time to local recurrence per treated nodule | Will be measured from the first date of treatment and characterized according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria and/or biopsy. The local recurrence of each subtype will be adjusted according to the method proposed by Fine and Gray. Will evaluate each basket individually and allow patients to contribute multiple nodules. Therefore, the Bayesian piecewise constant frailty model will be used to account for interdependence in the failure duration of nodules arising from the same patient. Additional posterior summaries will be reported, such as median failure duration. Additionally, will report plots of the full time-to-failure distribution with pointwise 95% Bayesian credible intervals. | Up to 2 years post-ablation | |
Secondary | Incidence of clinically significant adverse events | The occurrence of significant adverse events will be recorded according to the Common Terminology Criteria for Adverse Events (CTCAE) published by the National Institutes of Health. Grade III or above adverse events within the following categories: cardiac disorders, general disorders and administration site conditions, infections and infestations, injury, poisoning and procedural complications, and respiratory, thoracic and mediastinal disorders. 30-day mortality will also be recorded. Patient adverse events will be tabulated by symptom grade and categories. | Up to 30 days | |
Secondary | Time to local recurrence per patient | Contrast-enhanced CT imaging will be used to monitor for local recurrence. Local recurrence will be defined either by a positive biopsy or by radiographic RECIST criteria. Frequentist interference will use the Kaplan-Meier method. | Up to 2 years post-ablation | |
Secondary | Regional and distance recurrence | Regional and distant recurrence will be defined either by a positive biopsy or by radiographic RECIST criteria. Frequentist interference will use the Kaplan-Meier method. | Up to 2 years post-ablation | |
Secondary | Overall survival per patient | Frequentist interference will use the Kaplan-Meier method. | Up to 2 years post-ablation | |
Secondary | Changes in patient reported outcomes per patient | Will be reported as time to symptom recovering using MD Anderson Symptom Inventory-Lung Cancer (MDASI-LC) questionnaires. Frequentist interference will use the Kaplan-Meier method. | Up to 9 months after enrollment |
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