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

M.D. Anderson Cancer Center

Status: Active, not recruiting

Conditions: Stage IVC Colorectal Cancer AJCC v8; Stage IIIB Lung Cancer AJCC v8; Stage IIIA Lung Cancer AJCC v8; Stage III Lung Cancer AJCC v8; Stage IA2 Lung Cancer AJCC v8; Stage IVB Lung Cancer AJCC v8; Stage IB Lung Cancer AJCC v8; Stage IVA Colorectal Cancer AJCC v8; Stage IIIC Lung Cancer AJCC v8; Stage IA3 Lung Cancer AJCC v8; Lung Non-Small Cell Carcinoma; Stage IVB Colorectal Cancer AJCC v8; Stage IV Lung Cancer AJCC v8; Stage IA1 Lung Cancer AJCC v8; Stage I Lung Cancer AJCC v8; Stage IVA Lung Cancer AJCC v8; Stage IIB Lung Cancer AJCC v8; Stage IV Colorectal Cancer AJCC v8; Metastatic Sarcoma; Stage IIA Lung Cancer AJCC v8; Stage II Lung Cancer AJCC v8; Metastatic Colorectal Carcinoma

Treatments: Procedure: Wedge Excision; Procedure: Microwave Ablation; Procedure: Computed Tomography with Contrast; Other: Questionnaire Administration

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT04430725

2018-0301 (Other Identifier)

NCI-2020-03474 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 74 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

74 participants in 1 patient group

Observational (microwave ablation, wedge excision, CT)

Description:

Patients undergo standard care microwave ablation or wedge resection followed by contrast-enhanced CT imaging at 1, 6, 12, 18 and 24 months. Patients also complete questionnaires over 10-15 minutes at baseline up to 9 months.

Treatment:

Other: Questionnaire Administration

Procedure: Computed Tomography with Contrast

Procedure: Microwave Ablation

Procedure: Wedge Excision