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

  • STATUS
    Recruiting
  • participants needed
    120
  • sponsor
    M.D. Anderson Cancer Center
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Updated on 5 August 2020
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cancer
ct scan
lung cancer
sarcoma
microwave ablation
tumor cells
carcinoma
metastatic sarcoma
metastatic colorectal cancer
wedge resection
stage iv colorectal cancer
cancer, metastatic
ct with contrast
colorectal cancer
non-small cell lung cancer
ct scan with contrast
small cell lung cancer
computed tomography with contrast
wedge excision
therapeutic pneumothorax
stage iva colorectal cancer ajcc v8
carcinoma metastatic
stage iva lung cancer ajcc v8
stage iv lung cancer ajcc v8
stage iib lung cancer ajcc v8
stage ib lung cancer ajcc v8
stage ivb lung cancer ajcc v8
stage ia2 lung cancer ajcc v8
stage ivb colorectal cancer ajcc v8
stage iv colorectal cancer ajcc v8
stage iiib lung cancer ajcc v8
stage iii lung cancer ajcc v8
stage ia3 lung cancer ajcc v8
stage i lung cancer ajcc v8
stage iiic lung cancer ajcc v8
stage iiia lung cancer ajcc v8
stage iia lung cancer ajcc v8
stage ii lung cancer ajcc v8
stage ia1 lung cancer ajcc v8

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.

Details
Condition Stage IV 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 IVA Lung Cancer AJCC v8, Stage IVB Lung 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 IIA 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 II Lung Cancer AJCC v8, Stage IIB Lung Cancer AJCC v8, Lung Non-Small Cell Carcinoma, Metastatic Sarcoma
Age 18years - 100years
Treatment Microwave Ablation, Questionnaire Administration, Computed Tomography with Contrast, Wedge Excision
Clinical Study IdentifierNCT04430725
SponsorM.D. Anderson Cancer Center
Last Modified on5 August 2020

Eligibility

 Yes No Not Sure

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
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
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stage iv colorectal cancer
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ct scan with contrast
small cell lung cancer
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therapeutic pneumothorax
stage iva colorectal cancer ajcc v8
carcinoma metastatic
stage iva lung cancer ajcc v8
stage iv lung cancer ajcc v8
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