Trials / Active Not Recruiting
Active Not RecruitingNCT04430725
Microwave Ablation or Wedge Resection for the Treatment of Lung, Sarcoma and Colorectal Lesions, ALLUME Study
Ablation of Lung Lesions Using Microwave Energy (ALLUME)
- Status
- Active Not Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 74 (actual)
- Sponsor
- M.D. Anderson Cancer Center · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
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 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.
Conditions
- Lung Non-Small Cell Carcinoma
- Metastatic Colorectal Carcinoma
- Metastatic Sarcoma
- Stage I Lung Cancer AJCC v8
- Stage IA1 Lung Cancer AJCC v8
- Stage IA2 Lung Cancer AJCC v8
- Stage IA3 Lung Cancer AJCC v8
- Stage IB Lung Cancer AJCC v8
- Stage II Lung Cancer AJCC v8
- Stage IIA Lung Cancer AJCC v8
- Stage IIB Lung Cancer AJCC v8
- Stage III Lung Cancer AJCC v8
- Stage IIIA Lung Cancer AJCC v8
- Stage IIIB Lung Cancer AJCC v8
- Stage IIIC Lung Cancer AJCC v8
- Stage IV Colorectal Cancer AJCC v8
- Stage IV Lung Cancer AJCC v8
- Stage IVA Colorectal Cancer AJCC v8
- Stage IVA Lung Cancer AJCC v8
- Stage IVB Colorectal Cancer AJCC v8
- Stage IVB Lung Cancer AJCC v8
- Stage IVC Colorectal Cancer AJCC v8
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Computed Tomography with Contrast | Undergo contrast-enhanced CT |
| PROCEDURE | Microwave Ablation | Undergo microwave ablation |
| OTHER | Questionnaire Administration | Ancillary studies |
| PROCEDURE | Wedge Excision | Undergo wedge resection |
Timeline
- Start date
- 2019-08-07
- Primary completion
- 2026-01-01
- Completion
- 2026-01-01
- First posted
- 2020-06-12
- Last updated
- 2025-10-22
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT04430725. Inclusion in this directory is not an endorsement.