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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2020-03474 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 2018-0301 | Other Identifier | M D Anderson Cancer Center |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Computed Tomography with Contrast | Procedure | Undergo contrast-enhanced CT |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with non-small cell lung cancer, metastatic sarcoma, or metastatic colorectal cancer.
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| Name | Affiliation | Role |
|---|---|---|
| Wayne L Hofstetter | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| M D Anderson Cancer Center | Houston | Texas | 77030 | United States |
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| Label | URL |
|---|---|
| MD Anderson Cancer Center | View source |
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Tissue
| Microwave Ablation | Procedure | Undergo microwave ablation |
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| Questionnaire Administration | Other | Ancillary studies |
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| Wedge Excision | Procedure | Undergo wedge resection |
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| 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. | 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. | Up to 2 years post-ablation |
| Overall survival per patient | Frequentist interference will use the Kaplan-Meier method. | 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. | Up to 9 months after enrollment |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D015179 | Colorectal Neoplasms |
| D012509 | Sarcoma |
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D003287 | Contrast Media |
| D008872 | Microwaves |
| ID | Term |
|---|---|
| D064907 | Diagnostic Uses of Chemicals |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D020313 | Specialty Uses of Chemicals |
| D011846 | Radio Waves |
| D060733 | Electromagnetic Radiation |
| D055590 | Electromagnetic Phenomena |
| D060328 | Magnetic Phenomena |
| D055585 | Physical Phenomena |
| D011827 | Radiation |
| D011840 | Radiation, Nonionizing |
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