Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Digestive System Diseases

Rare Diseases

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Carcinoma

Sarcoma

Colorectal Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Neoplasms, Connective and Soft Tissue

Carcinoma, Bronchogenic

Bronchial Neoplasms

Soft Tissue Sarcoma

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.

Computed Tomography with Contrast

Microwave Ablation

Questionnaire Administration

Wedge Excision

Wayne L Hofstetter

Wayne L. Hofstetter

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.

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.

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

Ablation of Lung Lesions Using Microwave Energy (ALLUME)

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.

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.

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.

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.

Frequentist interference will use the Kaplan-Meier method.

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.

National Cancer Institute (NCI)

M.D. Anderson Cancer Center

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Microwave Ablation or Wedge Resection for the Treatment of Lung, Sarcoma and Colorectal Lesions, ALLUME Study	NCT04430725	Lung Non-Small ... Metastatic Colo... Metastatic Sarc... Stage I Lung Ca... Stage IA1 Lung ... Stage IA2 Lung ... Stage IA3 Lung ... Stage IB Lung C... Stage II Lung C... Stage IIA Lung ... Stage IIB Lung ... Stage III Lung ... Stage IIIA Lung... Stage IIIB Lung... Stage IIIC Lung... Stage IV Colore... Stage IV Lung C... Stage IVA Color... Stage IVA Lung ... Stage IVB Color... Stage IVB Lung ... Stage IVC Color...	Computed Tomogr... Microwave Ablat... Questionnaire A... Wedge Excision	18 Years -	M.D. Anderson Cancer Center
Microwave Ablation or Wedge Resection for the Treatment of Lung, Sarcoma and Colorectal Lesions, ALLUME Study	NCT04430725	Lung Non-Small ... Metastatic Colo... Metastatic Sarc... Stage I Lung Ca... Stage IA1 Lung ... Stage IA2 Lung ... Stage IA3 Lung ... Stage IB Lung C... Stage II Lung C... Stage IIA Lung ... Stage IIB Lung ... Stage III Lung ... Stage IIIA Lung... Stage IIIB Lung... Stage IIIC Lung... Stage IV Colore... Stage IV Lung C... Stage IVA Color... Stage IVA Lung ... Stage IVB Color... Stage IVB Lung ... Stage IVC Color...	Computed Tomogr... Microwave Ablat... Questionnaire A... Wedge Excision	18 Years -	M.D. Anderson Cancer Center

Spots Global Cancer Trial Database for wedge excision