Status:
COMPLETED
Surgery With or Without Internal Radiation Therapy in Treating Patients With Stage I Non-Small Cell Lung Cancer
Lead Sponsor:
Alliance for Clinical Trials in Oncology
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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...
Detailed Description
PRIMARY OBJECTIVES: I. To ascertain whether patients treated by sublobar resection (SR) + brachytherhapy (BX) have longer time to local recurrence as compared to the patients treated by SR (local rec...
Eligibility Criteria
Inclusion
- 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)
Exclusion
Key Trial Info
Start Date :
July 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 15 2019
Estimated Enrollment :
224 Patients enrolled
Trial Details
Trial ID
NCT00107172
Start Date
July 1 2005
End Date
February 15 2019
Last Update
October 18 2019
Active Locations (38)
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1
Mayo Clinic Scottsdale
Scottsdale, Arizona, United States, 85259-5499
2
University of California Davis Cancer Center
Sacramento, California, United States, 95817
3
Mayo Clinic - Jacksonville
Jacksonville, Florida, United States, 32224
4
Winship Cancer Institute of Emory University
Atlanta, Georgia, United States, 30322