Status:
ACTIVE_NOT_RECRUITING
Microwave Ablation or Wedge Resection for the Treatment of Lung, Sarcoma and Colorectal Lesions, ALLUME Study
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Lung Non-Small Cell Carcinoma
Metastatic Colorectal Carcinoma
Eligibility:
All Genders
18+ years
Brief 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...
Detailed 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 saf...
Eligibility Criteria
Inclusion
- 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
- Patient is considered high risk for ablation due to major comorbid medical conditions
- Patient is pregnant or breast feeding
Key Trial Info
Start Date :
August 7 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 1 2026
Estimated Enrollment :
74 Patients enrolled
Trial Details
Trial ID
NCT04430725
Start Date
August 7 2019
End Date
January 1 2026
Last Update
October 22 2025
Active Locations (1)
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1
M D Anderson Cancer Center
Houston, Texas, United States, 77030