Stereotactic Radiosurgery Followed by Wedge Resection in Treating Patients With Early Stage Peripheral Non-small Cell Lung Cancer

Recurrent Non-small Cell Lung Cancer Clinical Trial

Official title:

Feasibility Study of Stereotactic Body Radiation Therapy Followed by Wedge Resection for Peripherally Located Early Stage Non-small Cell Lung Cancer

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02250378
• Other study ID #: 2N-14-3
• Secondary ID: NCI-2014-019162N
• Status: Withdrawn
• Phase: N/A
• First received: September 23, 2014
• Last updated: September 14, 2015
• Start date: October 2014
• Est. completion date: September 2015

Study information

• Verified date: September 2015
• Source: University of Southern California
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

• Predicted postoperative forced expiratory volume in one second (FEV1) =< 40%

• Predicted postoperative DLCO =< 40%

• Age >= 72

• Minor criteria

• Predicted postoperative FEV1 41-60%

• Predicted postoperative DLCO 41-60%

• Pulmonary hypertension (defined by a pulmonary artery systolic pressure greater than 40 mm Hg) as estimated by echocardiography or right heart catheterization

• Poor left ventricular function (defined as an ejection fraction 40% or less)

• Resting or exercising arterial partial pressure of oxygen (pO2) =< 55 mmHg or oxygen saturation (SpO2) =< 88%

• Partial pressure of carbon monoxide (pCO2) > 45 mm Hg

• Modified Medical Research Council Dyspnea Scale >= 3

• 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:

• Has not undergone a hysterectomy or bilateral oophorectomy; or

• Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months)

• Ability to understand and the willingness to sign a written informed consent

Exclusion Criteria:

• Pregnant women

• Patients with central tumors within the proximal tree or touching the mediastinal pleura

• Patients with evidence of distant metastatic disease

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Recurrent Non-small Cell Lung Cancer
• Stage IA Non-small Cell Lung Cancer
• Stage IB Non-small Cell Lung Cancer

Intervention

Radiation:
• stereotactic radiosurgery
Undergo stereotactic radiosurgery

Procedure:
• therapeutic conventional surgery
Undergo wedge resection

Other:
• laboratory biomarker analysis
Correlative studies
• quality-of-life assessment
Ancillary studies

Locations

Country	Name	City	State
United States	USC Norris Comprehensive Cancer Center	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
University of Southern California	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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).	Up to 30 days after stereotactic radiosurgery	No
Other	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).	Baseline to up to 30 days after stereotactic radiosurgery	No
Other	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).	Baseline to up to 12 months after surgery	No
Other	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).	Baseline to up to 12 months after surgery	No
Other	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).	Baseline to up to 12 months after surgery	No
Primary	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.	Up to 12 months after surgery	Yes
Primary	Rates of perioperative complications including blood loss, days in the intensive care unit, and operative time		Up to 12 months after surgery	No
Primary	Feasibility, determined by the number of patients who are able to complete wedge resection as well as receive the full dose of stereotactic radiosurgery		Up to 12 months after surgery	No
Secondary	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).	Up to 12 months after surgery	No
Secondary	Quality of life assessment	Quality of life assessments will be summarized over time with descriptive statistics.	Up to 12 months after surgery	No