Comparing microwave ablation and wedge resection for treating lung and colorectal cancer
Ablation of Lung Lesions Using Microwave Energy (ALLUME)
This study is testing whether microwave ablation or surgical wedge resection is a safer and more effective treatment for people with certain types of lung and colorectal cancer.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | M.D. Anderson Cancer Center Academic / other |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT04430725 on ClinicalTrials.gov |
What this trial studies
This study compares the safety and outcomes of two treatment options, microwave ablation and surgical wedge resection, for patients with non-small cell lung cancer, metastatic sarcoma, and metastatic colorectal cancer. Microwave ablation uses heat to destroy tumor cells, while wedge resection involves surgically removing a small piece of lung tissue. The study aims to estimate the local recurrence rate of microwave ablation and evaluate its efficacy and safety compared to wedge resection using a contemporaneous database. Patients will undergo imaging and complete questionnaires over a period of 24 months to assess their outcomes.
Who should consider this trial
Good fit: Ideal candidates are patients with biopsy-proven lung lesions or those showing growth on CT imaging, with tumor sizes of 3 cm or less.
Not a fit: Patients with major comorbid conditions that increase the risk for ablation or those who are pregnant or breastfeeding may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help identify the more effective treatment option for patients with specific types of cancer, potentially improving patient outcomes.
How similar studies have performed: Other studies have shown promising results with microwave ablation for similar conditions, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Houston, Texas
- M D Anderson Cancer Center — Houston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Wayne L Hofstetter — M.D. Anderson Cancer Center
- Study coordinator: Wayne L Hofstetter
- Email: whofstetter@mdanderson.org
- Phone: 713-563-0136
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.