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| Sponsor: | Accuray Incorporated |
|---|---|
| Information provided by: | Accuray Incorporated |
| ClinicalTrials.gov Identifier: | NCT00643318 |
Purpose
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)
Eligibility| 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:
Contacts and Locations| 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 |
More Information
| 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 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 |