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Closed study as requested by PI due to lack of accruals
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This phase I trial studies the side effects and best dose of stereotactic body radiation therapy when given together with ablation therapy in treating patients with non-small cell lung cancer or lung metastases. Ablation therapy, such as radiofrequency ablation uses a high-frequency, electric current to kill tumor cells. Ablation therapy, such as microwave ablation kills tumor cells by heating them to several degrees above normal body temperature. Stereotactic body radiation therapy may be able to send x-rays directly to the tumor and cause less damage to normal tissue. Giving ablation therapy together with stereotactic body radiation therapy may kill more tumor cells.
This is a dose-escalation study of stereotactic body radiation therapy.
Patients undergo stereotactic body radiation therapy once daily (QD) for a total of 5 fractions and then undergo IRGA (either radiofrequency ablation or microwave ablation) 1 week later.
After completion of study treatment, patients are followed up at 4 weeks, every 3 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stereotactic Body RT and IRGA | Experimental | Patients undergo stereotactic body radiation therapy QD for a total of 5 fractions and then undergo IRGA (either radiofrequency ablation or microwave ablation) 1 week later. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stereotactic body RT and IRGA | Radiation | SABR Treatment with Dose escalation: Group 1: 40 Gy/5 fractions Group 2: 45 Gy/5 fractions Group 3: 50 Gy/5 fractions then IRGA procedure 1 week later with repeat lung biopsies, serum studies |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Tolerated Dose (MTD) | The MTD will be defined as the highest dose level where less than or equal to 33% patients incurred a dose-limiting toxicity (DLT). A DLT will be defined as an acute (within 30 days) or subacute (31-90 days) irreversible grade 3 or any grade 4-5 toxicity (using National Cancer Institute [NCI]-Common Toxicity Criteria [CTC] version 4.0 criteria) that is possibly, probably, and definitely attributed to the therapy. | 30 to 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| Survival | Rates of local control, disease-free survival, and overall survival | Up to 6 years |
| Biomarker testing | Size of tissue samples sufficient for DNA analyses |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas Schroeder, MD | UNM Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of New Mexico Cancer Center | Albuquerque | New Mexico | 87131 | United States |
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| Label | URL |
|---|---|
| UNM Cancer Center | View source |
| New Mexico Cancer Care Alliance | View source |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D009362 | Neoplasm Metastasis |
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
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| ID | Term |
|---|---|
| D000078703 | Radiofrequency Ablation |
| ID | Term |
|---|---|
| D000078702 | Radiofrequency Therapy |
| D013812 | Therapeutics |
| D055011 | Ablation Techniques |
| D013514 | Surgical Procedures, Operative |
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|
| 2 weeks |
| Pathological Response | Pathological response, changes in protein expression, and biomarker correlations with clinical outcome | Up to 6 years |
| Quality of Life | Quality of life (European Organization for the Research and Treatment of Cancer [EORTC]) | Up to 6 years |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |