Microwave Ablation or Wedge Resection for the Treatment of Lung, Sarcoma and Colorectal Lesions, ALLUME Study
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Lung Non-Small Cell Carcinoma
- Metastatic Colorectal Carcinoma
- Stage IV Colorectal Cancer AJCC v8
- Stage IVC Colorectal Cancer AJCC v8
- Metastatic Sarcoma
- Stage IVA Colorectal Cancer AJCC v8
- Stage I Lung Cancer AJCC v8
- Stage IA1 Lung Cancer AJCC v8
- Stage III Lung Cancer AJCC v8
- Stage IIIB Lung Cancer AJCC v8
- Stage IVB Lung Cancer AJCC v8
- Stage IA2 Lung Cancer AJCC v8
- Stage IA3 Lung Cancer AJCC v8
- Stage IVA Lung Cancer AJCC v8
- Stage IIIA Lung Cancer AJCC v8
- Stage IB Lung Cancer AJCC v8
- Stage II Lung Cancer AJCC v8
- Stage IIA Lung Cancer AJCC v8
- Stage IV Lung Cancer AJCC v8
- Stage IVB Colorectal Cancer AJCC v8
- Stage IIB Lung Cancer AJCC v8
- Stage IIIC Lung Cancer AJCC v8
- Type
- Observational
- Design
- Observational Model: CohortTime Perspective: Prospective
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
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 surg...
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.
Tracking Information
- NCT #
- NCT04430725
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Principal Investigator: Wayne L Hofstetter M.D. Anderson Cancer Center
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