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Sponsored by: |
Accuray Incorporated |
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Information provided by: | Accuray Incorporated |
ClinicalTrials.gov Identifier: | NCT00643318 |
The purpose of this study is to assess the short and long-term outcomes after CyberKnife stereotactic radiosurgery for early stage non-small cell lung cancer (NSCLC) in patients who are medically inoperable.
Condition | Intervention | Phase |
---|---|---|
Non-Small Cell Lung Cancer |
Radiation: CyberKnife Stereotactic Radiosurgery |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Efficacy Study |
Official Title: | A Prospective Evaluation of Outcomes of Radiosurgical Treatment of Early Stage Non-Small Cell Lung Cancer (NSCLC) |
Estimated Enrollment: | 156 |
Study Start Date: | April 2006 |
Estimated Study Completion Date: | July 2013 |
Estimated Primary Completion Date: | July 2013 (Final data collection date for primary outcome measure) |
Central tumors defined as < 2 cm from carina and < 2 cm from right and left mainstem bronchus and/or < 2 cms from the right and left upper lobe bronchus, bronchus intermedius, middle lobe bronchus, and the right and left lower lobe bronchus. For central tumors, 4 fractions of 12 Gy will be delivered (12 Gy x 4 fractions = 48 Gy)
Peripheral tumors are defined as being > 2 cms from the carina and > 2 cms from the right and left mainstem bronchus and/or > 2 cms from the right and left upper lobe bronchus, bronchus intermedius, middle lobe bronchus and the right and left lower lobe bronchus. For peripheral tumors, 3 fractions of 20 Gy will be delivered (20 Gy x 3 fractions = 60 Gy)
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
MAJOR CRITERIA:
MINOR CRITERIA:
Exclusion Criteria:
Contact: Joanne N Davis, PhD | 248-719-2998 | jdavis@accuray.com |
Contact: Omar Dawood, MD, MPH | 408-789-4457 | odawood@accuray.com |
United States, Arizona | |
St Joseph's Hospital/Barrow Neurological Institute | Recruiting |
Phoenix, Arizona, United States | |
Contact: Theresa Thomas theresa@azoncology.com | |
United States, California | |
Stanford University | Recruiting |
Palo Alto, California, United States | |
Contact: Lisa Zhou, PhD yaya@stanford.edu | |
Principal Investigator: Richard Whyte, MD | |
Principal Investigator: William Loo, MD | |
Regional Community Hospital | Active, not recruiting |
Fresno, California, United States | |
United States, District of Columbia | |
Georgetown University | Active, not recruiting |
Washington DC, District of Columbia, United States | |
United States, Illinois | |
Northwest Community Hospital | Recruiting |
Arlington Heights, Illinois, United States | |
Contact: Josie Smudde jsmudde@nch.org | |
Principal Investigator: Stephen Nigh, MD | |
United States, Indiana | |
St. Catherine's Hospital | Recruiting |
Munster, Indiana, United States, 46321 | |
Contact: Mindy Mendoza mmendoza@comhs.org | |
Principal Investigator: David Bryant, MD | |
United States, Oklahoma | |
St. Anthony's Hospital | Recruiting |
Oklahoma City, Oklahoma, United States | |
Contact: Vikki Harriott vikki@swrads.org | |
Principal Investigator: Clinton Medbery, MD | |
United States, Pennsylvania | |
James Luketich, MD | Recruiting |
Pittsburgh, Pennsylvania, United States, 15213 | |
Contact: Julie Ward, RN |
Study Chair: | James Luketich, MD | University of Pittsburgh |
Responsible Party: | Accuray Incorporated ( Omar Dawood, MD, MPH ) |
Study ID Numbers: | ACCL001.0 |
Study First Received: | March 20, 2008 |
Last Updated: | January 8, 2009 |
ClinicalTrials.gov Identifier: | NCT00643318 History of Changes |
Health Authority: | United States: Institutional Review Board |
lung cancer lung tumor non-small cell lung cancer NSCLC |
CyberKnife radiosurgery lung surgery |
Thoracic Neoplasms Respiratory Tract Diseases Lung Neoplasms Lung Diseases |
Non-small Cell Lung Cancer Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial Carcinoma |
Thoracic Neoplasms Respiratory Tract Neoplasms Neoplasms Neoplasms by Site Neoplasms by Histologic Type Respiratory Tract Diseases |
Lung Neoplasms Lung Diseases Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial Carcinoma |