Microwave Ablation or Wedge Resection for the Treatment of Lung, Sarcoma and Colorectal Lesions, ALLUME Study

Phase

N/A

Condition

Metastatic Cancer

Sarcoma

Carcinoma

Treatment

Wedge Excision

Computed Tomography with Contrast

Questionnaire Administration

Clinical Study ID

NCT04430725

2018-0301

NCI-2020-03474

Ages > 18
All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Patient has a lung lesion(s) that is either biopsy-proven cancer or shows sequentialgrowth 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 protectivestrategies such as induction of therapeutic pneumothorax. Critical structuresinclude the trachea, main bronchi, esophagus, aorta, aortic arch branches, superiorvena cava (SVC), main, right or left pulmonary artery, or heart.

Exclusion

Exclusion Criteria:

Patient is considered high risk for ablation due to major comorbid medicalconditions
Patient is pregnant or breast feeding

Study Design

Wedge Excision

August 07, 2019

January 01, 2026

Study 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.

Connect with a study center

M D Anderson Cancer Center
Houston, Texas 77030
United States
Site Not Available
M D Anderson Cancer Center
Houston 4699066, Texas 4736286 77030
United States
Site Not Available

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