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

Ablation of Lung Lesions Using Microwave Energy (ALLUME)

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.

Study Overview

• Status: Recruiting
• Conditions: Stage IVA Lung Cancer AJCC v8; Stage IVB Lung Cancer AJCC v8; Lung Non-Small Cell Carcinoma; Stage III Lung Cancer AJCC v8; Stage IV Lung Cancer AJCC v8; Stage II Lung Cancer AJCC v8; Stage IIA Lung Cancer AJCC v8; Stage IIB Lung Cancer AJCC v8; Stage IIIA Lung Cancer AJCC v8; Stage IIIB Lung Cancer AJCC v8; Metastatic Colorectal Carcinoma; Stage IV Colorectal Cancer AJCC v8; Stage IVA Colorectal Cancer AJCC v8; Stage IVB Colorectal Cancer AJCC v8; Stage IVC Colorectal Cancer AJCC v8; 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 IIIC Lung Cancer AJCC v8; Metastatic Sarcoma
• Intervention / Treatment: Other: Questionnaire Administration; Procedure: Computed Tomography with Contrast; Procedure: Microwave Ablation; Procedure: Wedge Excision

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.

• Study Type: Observational
• Enrollment (Estimated): 120

Contacts and Locations

• Study Contact: Name: Wayne L Hofstetter; Phone Number: 713-563-0136; Email: whofstetter@mdanderson.org

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • M D Anderson Cancer Center
      • Contact: Wayne L. Hofstetter; Phone Number: 713-563-0136
      • Principal Investigator: Wayne L. Hofstetter

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with non-small cell lung cancer, metastatic sarcoma, or metastatic colorectal cancer.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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.

Other: Questionnaire Administration; Ancillary studies; Procedure: Computed Tomography with Contrast; Undergo contrast-enhanced CT; Other Names: Contrast Enhanced Computed Tomography; CONTRAST ENHANCED CT SCAN; Contrast-enhanced Computed Tomography; CT Scan With Contrast; CT with Contrast; Procedure: Microwave Ablation; Undergo microwave ablation; Other Names: Ablation, Microwave; Procedure: Wedge Excision; Undergo wedge resection; Other Names: Wedge Resection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to local recurrence per treated nodule	Will be measured from the first date of treatment and characterized according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria and/or biopsy. The local recurrence of each subtype will be adjusted according to the method proposed by Fine and Gray. Will evaluate each basket individually and allow patients to contribute multiple nodules. Therefore, the Bayesian piecewise constant frailty model will be used to account for interdependence in the failure duration of nodules arising from the same patient. Additional posterior summaries will be reported, such as median failure duration. Additionally, will report plots of the full time-to-failure distribution with pointwise 95% Bayesian credible intervals.	Up to 2 years post-ablation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of clinically significant adverse events	The occurrence of significant adverse events will be recorded according to the Common Terminology Criteria for Adverse Events (CTCAE) published by the National Institutes of Health. Grade III or above adverse events within the following categories: cardiac disorders, general disorders and administration site conditions, infections and infestations, injury, poisoning and procedural complications, and respiratory, thoracic and mediastinal disorders. 30-day mortality will also be recorded. Patient adverse events will be tabulated by symptom grade and categories.	Up to 30 days
Time to local recurrence per patient	Contrast-enhanced CT imaging will be used to monitor for local recurrence. Local recurrence will be defined either by a positive biopsy or by radiographic RECIST criteria. Frequentist interference will use the Kaplan-Meier method.	Up to 2 years post-ablation
Regional and distance recurrence	Regional and distant recurrence will be defined either by a positive biopsy or by radiographic RECIST criteria. Frequentist interference will use the Kaplan-Meier method.	Up to 2 years post-ablation
Overall survival per patient	Frequentist interference will use the Kaplan-Meier method.	Up to 2 years post-ablation
Changes in patient reported outcomes per patient	Will be reported as time to symptom recovering using MD Anderson Symptom Inventory-Lung Cancer (MDASI-LC) questionnaires. Frequentist interference will use the Kaplan-Meier method.	Up to 9 months after enrollment

Collaborators and Investigators

• Sponsor: M.D. Anderson Cancer Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Wayne L Hofstetter, M.D. Anderson Cancer Center

Publications and helpful links

Helpful Links

• MD Anderson Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): August 7, 2019
• Primary Completion (Estimated): January 1, 2026
• Study Completion (Estimated): January 1, 2026

Study Registration Dates

• First Submitted: June 10, 2020
• First Submitted That Met QC Criteria: June 10, 2020
• First Posted (Actual): June 12, 2020

Study Record Updates

• Last Update Posted (Estimated): February 15, 2024
• Last Update Submitted That Met QC Criteria: February 14, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Respiratory Tract Diseases; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Lung Diseases; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Sarcoma; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Carcinoma; Colorectal Neoplasms
• Other Study ID Numbers: 2018-0301 (Other Identifier: M D Anderson Cancer Center); NCI-2020-03474 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No