Clinical trial NCT04430725: Microwave Ablation or Wedge Resection for the Treatment of Lung, Sarcoma and Colorectal Lesions, ALLUME Study
Official title: Ablation of Lung Lesions Using Microwave Energy (ALLUME)
Study type: OBSERVATIONAL
Overall status: RECRUITING
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
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
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2020-06-12
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with non-small cell lung cancer, metastatic sarcoma, or metastatic colorectal cancer.

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Time to local recurrence per treated nodule
timeFrame: Up to 2 years post-ablation
Secondary outcomes:
measure: Incidence of clinically significant adverse events
timeFrame: Up to 30 days
measure: Time to local recurrence per patient
timeFrame: Up to 2 years post-ablation
measure: Regional and distance recurrence
timeFrame: Up to 2 years post-ablation
measure: Overall survival per patient
timeFrame: Up to 2 years post-ablation
measure: Changes in patient reported outcomes per patient
timeFrame: Up to 9 months after enrollment
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Wayne L Hofstetter
role: PRINCIPAL_INVESTIGATOR
References: