Surgery With or Without Internal Radiation Therapy in Treating Patients With Stage I Non-Small Cell Lung Cancer
This randomized phase III trial studies surgery and internal radiation therapy to see how well they work compared to surgery alone in treating patients with stage I non-small cell lung cancer. Surgery may be an effective treatment for non-small cell lung cancer. Internal radiation uses radioactive material placed directly into or near a tumor to kill tumor cells. It is not yet known whether surgery and internal radiation therapy are more effective than surgery alone in treating non-small cell lung cancer.
Checked against the public recordLast updated Oct 18, 2019 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 3
- Sponsor
- Alliance for Clinical Trials in Oncology
- Interventions being studied
- Procedure: surgery; Radiation: brachytherapy
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: * PART I: PRE-OPERATIVE CRITERIA (PRE-REGISTRATION/RANDOMIZATION) * Patients must have a suspicious lung nodule for clinical stage I non-small cell lung cancer (NSCLC) * Patient must have a mass =\< 3 cm maximum diameter by computed tomography (CT) size estimate: clinical stage Ia or selected Ib (i.e., with visceral pleural involvement) * Patient must have a CT scan of the chest with upper abdomen within 60 days prior to date of pre-registration * Eastern Cooperative Oncology Group (ECOG)/Zubrod performance status 0, 1, or 2 * Patient must meet at least one major criteria or meet a minimum of two minor criteria as described below: * Major criteria * Forced expiratory volume in 1 second (FEV1) =\< 50% predicted * Diffusing capacity of the lungs for carbon monoxide (DLCO) =\< 50% predicted * Minor criteria * Age \>= 75 * FEV1 51-60% predicted * DLCO 51-60% predicted * Pulmonary hypertension (defined as a pulmonary artery systolic pressure greater than 40 mmHg) as estimated by echocardiography or right heart catheterization * Poor left ventricular function (defined as an ejection fraction of 40% or less) * Resting or exercise partial pressure of oxygen (pO2) =\< 55 mm Hg or peripheral capillary oxygen saturation (SpO2) =\< 88% * Partial pressure of carbon dioxide (pCO2) \> 45 mm Hg * Modified Medical Research Council (MMRC) Dyspnea Scale \>= 3 * Patient must not have had previous intra-thoracic radiation therapy * Women of child-bearing potential must have negative serum or urine pregnancy test * No prior invasive malignancy, unless disease-free for \>= 5 years prior to pre-registration (exceptions: non-melanoma skin cancer, in-situ cancers) * PART II: INTRA-OPERATIVE CRITERIA (REGISTRATION) * Patient must have biopsy-proven NSCLC * Patient must have all suspicious mediastinal lymph nodes (\> 1 cm short-axis dimension on CT scan or positive on positron emission tomography \[PET\] scan) assessed by one of the following methods to confirm negative involvement with NSCLC (mediastinoscopy, endo-esophageal ultrasound guided needle aspiration, CT-guided, video-assisted thoracoscopic or open lymph node biopsy)
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Mayo Clinic ScottsdaleScottsdale, Arizona
- University of California Davis Cancer CenterSacramento, California
- Mayo Clinic - JacksonvilleJacksonville, Florida
- Winship Cancer Institute of Emory UniversityAtlanta, Georgia
- Evanston HospitalEvanston, Illinois
- Cancer Institute at St. John's HospitalSpringfield, Illinois
- Regional Cancer Center at Memorial Medical CenterSpringfield, Illinois
- Simmons Cooper Cancer InstituteSpringfield, Illinois
- Cancer Institute at St. Joseph Medical CenterTowson, Maryland
- Boston University Cancer Research CenterBoston, Massachusetts
- University of Michigan Comprehensive Cancer CenterAnn Arbor, Michigan
- Mayo Clinic Cancer CenterRochester, Minnesota
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Oct 18, 2019. Always confirm current availability with the study team.