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

Primary Purpose

Recurrent Non-small Cell Lung Cancer, Stage IA Non-small Cell Lung Cancer, Stage IB Non-small Cell Lung Cancer

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
stereotactic radiosurgery
therapeutic conventional surgery
laboratory biomarker analysis
quality-of-life assessment
Sponsored by
University of Southern California
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Recurrent Non-small Cell Lung Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • USC Norris Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment (stereotactic radiosurgery, wedge resection)

Arm Description

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.

Outcomes

Primary Outcome Measures

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.
Rates of perioperative complications including blood loss, days in the intensive care unit, and operative time
Feasibility, determined by the number of patients who are able to complete wedge resection as well as receive the full dose of stereotactic radiosurgery

Secondary Outcome Measures

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).
Quality of life assessment
Quality of life assessments will be summarized over time with descriptive statistics.

Full Information

First Posted
September 23, 2014
Last Updated
September 14, 2015
Sponsor
University of Southern California
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT02250378
Brief Title
Stereotactic Radiosurgery Followed by Wedge Resection in Treating Patients With Early Stage Peripheral Non-small Cell Lung Cancer
Official Title
Feasibility Study of Stereotactic Body Radiation Therapy Followed by Wedge Resection for Peripherally Located Early Stage Non-small Cell Lung Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Withdrawn
Why Stopped
No accrual
Study Start Date
October 2014 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
September 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Southern California
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrent Non-small Cell Lung Cancer, Stage IA Non-small Cell Lung Cancer, Stage IB Non-small Cell Lung Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment (stereotactic radiosurgery, wedge resection)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Radiation
Intervention Name(s)
stereotactic radiosurgery
Intervention Description
Undergo stereotactic radiosurgery
Intervention Type
Procedure
Intervention Name(s)
therapeutic conventional surgery
Intervention Description
Undergo wedge resection
Intervention Type
Other
Intervention Name(s)
laboratory biomarker analysis
Intervention Description
Correlative studies
Intervention Type
Other
Intervention Name(s)
quality-of-life assessment
Other Intervention Name(s)
quality of life assessment
Intervention Description
Ancillary studies
Primary Outcome Measure Information:
Title
Rate of grade 3-5 adverse events, graded according to National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03
Description
Treatment related toxicities will be assessed and recorded for each patient receiving treatment.
Time Frame
Up to 12 months after surgery
Title
Rates of perioperative complications including blood loss, days in the intensive care unit, and operative time
Time Frame
Up to 12 months after surgery
Title
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 Outcome Measure Information:
Title
Pathologic response rates
Description
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
Title
Quality of life assessment
Description
Quality of life assessments will be summarized over time with descriptive statistics.
Time Frame
Up to 12 months after surgery
Other Pre-specified Outcome Measures:
Title
Imaging characteristics that may predict response based on DP-CT and PET-CT scans
Description
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
Title
Changes in perfusion using DP-CT scans
Description
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
Title
Changes in FDG uptake
Description
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
Title
Changes in DNA methylation analysis
Description
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
Title
Changes in CTC levels
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eugene Chung
Organizational Affiliation
University of Southern California
Official's Role
Principal Investigator
Facility Information:
Facility Name
USC Norris Comprehensive Cancer Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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