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| Sponsored by: |
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 |
| MedlinePlus related topics: | Cancer Lung Cancer |
| 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, Pennsylvania | |||||
| James Luketich, MD | Recruiting | ||||
| Pittsburgh, Pennsylvania, United States, 15213 | |||||
| Contact: Julie Ward, RN | |||||
| Accuray Incorporated |
| Study Chair: | James Luketich, MD | University of Pittsburgh |
More Information
Accuray Website 
  |
| Responsible Party: | Accuray Incorporated ( Omar Dawood, MD, MPH ) |
| Study ID Numbers: | ACCL001.0 |
| First Received: | March 20, 2008 |
| Last Updated: | March 20, 2008 |
| ClinicalTrials.gov Identifier: | NCT00643318 |
| Health Authority: | United States: Institutional Review Board |
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