Status:
WITHDRAWN
Stereotactic Radiosurgery Followed by Wedge Resection in Treating Patients With Early Stage Peripheral Non-small Cell Lung Cancer
Lead Sponsor:
University of Southern California
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Recurrent Non-small Cell Lung Cancer
Stage IA Non-small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
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 loc...
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). S...
Eligibility Criteria
Inclusion
- 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
- Pregnant women
- Patients with central tumors within the proximal tree or touching the mediastinal pleura
- Patients with evidence of distant metastatic disease
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2015
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT02250378
Start Date
October 1 2014
End Date
September 1 2015
Last Update
September 16 2015
Active Locations (1)
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1
USC Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033