An interventional study of stereotactic radiosurgery and therapeutic conventional surgery in Recurrent Non-small Cell Lung Cancer, Stage IA Non-small Cell Lung Cancer and Stage IB Non-small Cell Lung Cancer, sponsored by University of Southern California. Withdrawn at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-09-16.
Sponsored by University of Southern California · Not applicable, Interventional, and Treatment
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.
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.
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Patient at high-risk of complications from lobectomy meeting a minimum of one major criteria or two minor criteria as described below:
Major criteria
Minor criteria
Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:
Exclusion Criteria:
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.
Radiation: stereotactic radiosurgery · Procedure: therapeutic conventional surgery · Other: laboratory biomarker analysis · Other: quality-of-life assessment
Undergo stereotactic radiosurgery
Undergo wedge resection
Correlative studies
Ancillary studies
Also known as: quality of life assessment
Rate of grade 3-5 adverse events, graded according to National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03
Treatment related toxicities will be assessed and recorded for each patient receiving treatment.
Time frame: Up to 12 months after surgery
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
Pathologic response rates
The pathologic response rates will be determined by measuring the percent of viable cells in the resected specimen. Associations (e.g. between pathologic response rates and DP-CT, fludeoxyglucose \[FDG\] uptake, DNA methylation, and CTC levels) will be displayed visually with scatterplots or contingency tables and appropriate measure of association (Wilcoxon test, Fisher's exact test, Spearman correlation coefficient, and McNemar's test).
Time frame: Up to 12 months after surgery
Quality of life assessment
Quality of life assessments will be summarized over time with descriptive statistics.
Time frame: Up to 12 months after surgery
Imaging characteristics that may predict response based on DP-CT and PET-CT scans
Associations (e.g. between pathologic response rates and DP-CT, FDG uptake, DNA methylation, and CTC levels) will be displayed visually with scatterplots or contingency tables and appropriate measure of association (Wilcoxon test, Fisher's exact test, Spearman correlation coefficient, and McNemar's test).
Time frame: Up to 30 days after stereotactic radiosurgery
Changes in perfusion using DP-CT scans
Changes in DP-CT will be compared between pre- and post-stereotactic radiosurgery scans to determine if changes in perfusion correlates with pathologic response. Associations (e.g. between pathologic response rates and DP-CT, FDG uptake, DNA methylation, and CTC levels) will be displayed visually with scatterplots or contingency tables and appropriate measure of association (Wilcoxon test, Fisher's exact test, Spearman correlation coefficient, and McNemar's test).
Time frame: Baseline to up to 30 days after stereotactic radiosurgery
Changes in FDG uptake
Changes in FDG uptake will be compared between pre- and post-SBRT scans to determine if changes in FDG uptake correlates with pathologic response. Associations (e.g. between pathologic response rates and DP-CT, FDG uptake, DNA methylation, and CTC levels) will be displayed visually with scatterplots or contingency tables and appropriate measure of association (Wilcoxon test, Fisher's exact test, Spearman correlation coefficient, and McNemar's test).
Time frame: Baseline to up to 12 months after surgery
Changes in DNA methylation analysis
The amount of DNA methylation in the blood as well as relative changes in counts will be correlated with pathologic outcomes. DNA methylation will be summarized over time with descriptive statistics. Associations (e.g. between pathologic response rates and DP-CT, FDG uptake, DNA methylation, and CTC levels) will be displayed visually with scatterplots or contingency tables and appropriate measure of association (Wilcoxon test, Fisher's exact test, Spearman correlation coefficient, and McNemar's test).
Time frame: Baseline to up to 12 months after surgery
Changes in CTC levels
The amount of CTC in the blood as well as relative changes in counts will be correlated with pathologic outcomes. CTC levels will be summarized over time with descriptive statistics. Associations (e.g. between pathologic response rates and DP-CT, FDG uptake, DNA methylation, and CTC levels) will be displayed visually with scatterplots or contingency tables and appropriate measure of association (Wilcoxon test, Fisher's exact test, Spearman correlation coefficient, and McNemar's test).
Time frame: Baseline to up to 12 months after surgery
This study is withdrawn, as verified in Sep 2015. You cannot join it, but the record below documents what was studied.
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