Feasibility Study of Stereotactic Body Radiation Therapy Followed by Wedge Resection for Peripherally Located Early Stage Non-small Cell Lung Cancer
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Recurrent Non-small Cell Lung Cancer
- Sponsor
- University of Southern California
- Locations
- 1
- Primary Endpoint
- Rate of grade 3-5 adverse events, graded according to National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03
- Status
- Withdrawn
- Last Updated
- 10 years ago
Overview
Brief Summary
This pilot clinical trial studies the side effects and how well stereotactic radiosurgery followed by wedge resection works in treating patients with early stage non-small cell lung cancer that is located in the outer, or peripheral, areas of the lung. Stereotactic radiosurgery, also known as stereotactic body radiation therapy, is a specialized radiation therapy that delivers a single, high dose of radiation directly to the tumor and may kill more tumor cells and cause less damage to normal tissue. Wedge resection is a less invasive type of surgery for removal of the tumor and a small amount of normal tissue around it. Giving stereotactic radiosurgery followed by wedge resection may be a safe treatment option for patients who cannot receive standard treatment with lobectomy.
Detailed Description
PRIMARY OBJECTIVES: I. To assess the safety and feasibility of a wedge resection following stereotactic body radiation therapy (SBRT) for early stage peripheral non-small cell lung cancer (NSCLC). SECONDARY OBJECTIVES: I. To assess pathologic response rates to SBRT as determined by pathologic examination of resected tumors. II. To prospectively assess patient quality of life when treated with SBRT and wedge resection. TERTIARY OBJECTIVES: I. To describe the location of viable tumor and to correlate pathologic response rates with radiation dose, size of tumor, and tumor histology. II. To correlate pathologic response rates and functional imaging with pre- and post-treatment dual-input perfusion (DP)-computed tomography (CT) and positron emission tomography (PET)-CT. III. To correlate changes in serum levels of deoxyribonucleic acid (DNA) methylation and circulating tumor cells (CTC) with pathologic response rates. OUTLINE: Patients undergo stereotactic radiosurgery every other day for 3 or 5 fractions (depending on the size tumor and proximity to the chest wall). Within 4-6 weeks after completion of stereotactic radiosurgery, patients undergo wedge resection. After completion of study treatment, patients are followed up at 1, 3, 6, and 12 months.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2
- •Biopsy proven non-small cell lung cancer
- •Maximum tumor dimension =\< 5 cm
- •No clinical evidence of N1, N2 or N3 lymph nodes as assessed by CT and/or PET-CT
- •No evidence of distant metastatic disease
- •Tumor verified by a thoracic surgeon to be in a location that will permit a sublobar resection
- •Tumor located peripherally within the lung (peripheral defined as not touching any surface within 2 cm of the proximal bronchial tree in all directions) and not touching the mediastinal pleura
- •Pulmonary function tests (PFTs) with diffusing capacity of the lung for carbon monoxide (DLCO) within 90 days prior to registration
- •Patient at high-risk of complications from lobectomy meeting a minimum of one major criteria or two minor criteria as described below:
- •Major criteria
Exclusion Criteria
- •Pregnant women
- •Patients with central tumors within the proximal tree or touching the mediastinal pleura
- •Patients with evidence of distant metastatic disease
Outcomes
Primary Outcomes
Rate of grade 3-5 adverse events, graded according to National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03
Time Frame: Up to 12 months after surgery
Treatment related toxicities will be assessed and recorded for each patient receiving treatment.
Rates of perioperative complications including blood loss, days in the intensive care unit, and operative time
Time Frame: Up to 12 months after surgery
Feasibility, determined by the number of patients who are able to complete wedge resection as well as receive the full dose of stereotactic radiosurgery
Time Frame: Up to 12 months after surgery
Secondary Outcomes
- Pathologic response rates(Up to 12 months after surgery)
- Quality of life assessment(Up to 12 months after surgery)