Lung Non-Small Cell CarcinomaNCT04430725

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

An observational study of Lung Non-Small Cell Carcinoma and Metastatic Colorectal Carcinoma, run by M.D. Anderson Cancer Center at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Lung Non-Small Cell Carcinoma, Metastatic Colorectal Carcinoma, Metastatic Sarcoma
What is being tested?: Computed Tomography with Contrast, Microwave Ablation and Questionnaire Administration
Type of treatment: Surgery or procedure
How many people: 74 participants
Where: 1 siteUnited States
Study dates: 7 Aug 2019to 1 Jan 2028
Phase: Observational

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

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

Who may be able to join

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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

M D Anderson Cancer Center
Houston, Texas, 77030

Other trials in United States

About this study

Official title: 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.

Read the detailed description

PRIMARY OBJECTIVE:

Estimate the 2-year local recurrence rate for microwave ablation within a basket.

SECONDARY OBJECTIVES:

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: 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
Being tested: Computed Tomography with Contrast, Microwave Ablation, Questionnaire Administration, Wedge Excision
Medical subject headings: Carcinoma, Non-Small-Cell Lung, Colorectal Neoplasms, Sarcoma, Lung Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Computed Tomography with ContrastProcedure or surgery
Also called Contrast Enhanced Computed Tomography, CONTRAST ENHANCED CT SCAN, Contrast-enhanced Computed Tomography, CT Scan With Contrast
Undergo contrast-enhanced CT
Microwave AblationProcedure or surgery
Also called Ablation, Microwave
Undergo microwave ablation
Questionnaire AdministrationOther
Ancillary studies
Wedge ExcisionProcedure or surgery
Also called Wedge Resection
Undergo wedge resection

Study groups in NCT04430725
Study group	Role	What they receive
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. Receives: Procedure: Computed Tomography with Contrast; Procedure: Microwave Ablation; Other: Questionnaire Administration; Procedure: Wedge Excision

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Up to 2 years post-ablation

Secondary outcomes (5)

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.
Measured: 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.
Measured: 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.
Measured: Up to 2 years post-ablation
Overall survival per patient
Frequentist interference will use the Kaplan-Meier method.
Measured: 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.
Measured: Up to 9 months after enrollment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

7 Aug 20191 Jan 2028

First posted12 Jun 2020
Study start7 Aug 2019
Primary completion1 Jan 2028 (estimated)
Study completion1 Jan 2028 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Lung Non-Small Cell CarcinomaStudies of the same condition, open and under way.
More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 74 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04430725
Sponsor's protocol ID: 2018-0301
Other IDs: NCI-2020-03474, 2018-0301
Status last verified: Oct 2026
First submitted: 10 Jun 2020
Last updated: 7 Oct 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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