Surgery With or Without Internal Radiation Therapy in Treating Patients With Stage I Non-Small Cell Lung Cancer

Completed · Phase 3

Conditions studied: Lung Cancer

In brief

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.

Key facts

Study ID

NCT00107172

Run by

Alliance for Clinical Trials in Oncology

People needed

224

Starts

2005-07-01

Expected to finish

2019-02-15

Last updated by the study team

2019-10-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

Where it is running

• Cancer Institute at St. Joseph Medical Center — Towson, Maryland, United States
• Boston University Cancer Research Center — Boston, Massachusetts, United States
• University of Michigan Comprehensive Cancer Center — Ann Arbor, Michigan, United States
• Mayo Clinic Cancer Center — Rochester, Minnesota, United States
• Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis — St Louis, Missouri, United States
• Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center — Lebanon, New Hampshire, United States
• Valley Hospital - Ridgewood — Ridgewood, New Jersey, United States
• South Nassau Communities Hospital — Oceanside, New York, United States
• James P. Wilmot Cancer Center at University of Rochester Medical Center — Rochester, New York, United States
• SUNY Upstate Medical University Hospital — Syracuse, New York, United States
• Presbyterian Cancer Center at Presbyterian Hospital — Charlotte, North Carolina, United States
• Charles M. Barrett Cancer Center at University Hospital — Cincinnati, Ohio, United States
• Knight Cancer Institute at Oregon Health and Science University — Portland, Oregon, United States
• Jameson Memorial Hospital - North Campus — New Castle, Pennsylvania, United States
• Abramson Cancer Center of the University of Pennsylvania — Philadelphia, Pennsylvania, United States
• Kimmel Cancer Center at Thomas Jefferson University - Philadelphia — Philadelphia, Pennsylvania, United States
• Fox Chase Cancer Center - Philadelphia — Philadelphia, Pennsylvania, United States
• Allegheny Cancer Center at Allegheny General Hospital — Pittsburgh, Pennsylvania, United States
• UPMC Cancer Centers — Pittsburgh, Pennsylvania, United States
• McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center — Reading, Pennsylvania, United States
• Rhode Island Hospital Comprehensive Cancer Center — Providence, Rhode Island, United States
• Miriam Hospital — Providence, Rhode Island, United States
• U.T. Medical Center Cancer Institute — Knoxville, Tennessee, United States
• Methodist Hospital — Houston, Texas, United States
• Jon and Karen Huntsman Cancer Center at Intermountain Medical Center — Murray, Utah, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.