Stereotactic Radiosurgery Followed by Wedge Resection in Treating Patients With Early Stage Peripheral Non-small Cell Lung Cancer
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.
Checked against the public recordLast updated Sep 16, 2015 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Not applicable
- Sponsor
- University of Southern California
- Interventions being studied
- Radiation: stereotactic radiosurgery; Procedure: therapeutic conventional surgery; Other: laboratory biomarker analysis; Other: quality-of-life assessment
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
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
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- USC Norris Comprehensive Cancer CenterLos Angeles, California
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Sep 16, 2015. Always confirm current availability with the study team.