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

Stage IV Lung Cancer AJCC v8 Clinical Trial

Official title:

Ablation of Lung Lesions Using Microwave Energy (ALLUME)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04430725
• Other study ID #: 2018-0301
• Secondary ID: NCI-2020-0347420
• Status: Recruiting
• Start date: August 7, 2019
• Est. completion date: January 1, 2026

Study information

• Verified date: February 2024
• Source: M.D. Anderson Cancer Center
• Contact: Wayne L Hofstetter
• Phone: 713-563-0136
• Email: whofstetter[@]mdanderson.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: January 1, 2026
• Est. primary completion date: January 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Non-Small-Cell Lung
• Colorectal Neoplasms
• Lung Neoplasms
• Lung Non-Small Cell Carcinoma
• Metastatic Colorectal Carcinoma
• Metastatic Sarcoma
• 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

Intervention

Procedure:
• Computed Tomography with Contrast
Undergo contrast-enhanced CT
• Microwave Ablation
Undergo microwave ablation

Other:
• Questionnaire Administration
Ancillary studies

Procedure:
• Wedge Excision
Undergo wedge resection

Locations

Country	Name	City	State
United States	M D Anderson Cancer Center	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Overall survival per patient	Frequentist interference will use the Kaplan-Meier method.	Up to 2 years post-ablation
Secondary	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

External Links

•   MD Anderson Cancer Center