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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

74 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-08-07

Study Completion Date

2026-01-01

Brief Summary

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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.

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Detailed Description

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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

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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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Observational (microwave ablation, wedge excision, CT)

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.

Computed Tomography with Contrast

Intervention Type PROCEDURE

Undergo contrast-enhanced CT

Microwave Ablation

Intervention Type PROCEDURE

Undergo microwave ablation

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Wedge Excision

Intervention Type PROCEDURE

Undergo wedge resection

Interventions

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Computed Tomography with Contrast

Undergo contrast-enhanced CT

Intervention Type PROCEDURE

Microwave Ablation

Undergo microwave ablation

Intervention Type PROCEDURE

Questionnaire Administration

Ancillary studies

Intervention Type OTHER

Wedge Excision

Undergo wedge resection

Intervention Type PROCEDURE

Other Intervention Names

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Contrast Enhanced Computed Tomography CONTRAST ENHANCED CT SCAN Contrast-enhanced Computed Tomography CT Scan With Contrast CT with Contrast Ablation, Microwave Wedge Resection

Eligibility Criteria

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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.