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Sponsored by: |
Washington University School of Medicine |
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Information provided by: | Washington University School of Medicine |
ClinicalTrials.gov Identifier: | NCT00591838 |
The purpose of this study is to use SBRT in patients with early stage lung cancer and find out what effects (good and bad) SBRT has on their cancer. This research is being done because SBRT has not been used very often in patients with early stage lung cancer or in patients with other serious health problems. In addition, this study also will gather information about patient's health and hospitalization history. This information will be used to find out if there are any factors that can help predict recovery or outcome of patients with lung cancer.
Condition | Intervention | Phase |
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Inoperable Stage I/II Non-Small Cell Lung Cancer |
Radiation: Stereotactic Body Radiation Therapy (SBRT) |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase I/II Trial of Stereotactic Body Radiation Therapy (SBRT) Dose Escalation in the Treatment of Patients With Inoperable Stage I/II Non-Small Cell Lung Cancer Arising Within the Zone of the Proximal Bronchial Tree |
Estimated Enrollment: | 75 |
Study Start Date: | August 2006 |
Estimated Study Completion Date: | August 2015 |
Estimated Primary Completion Date: | August 2015 (Final data collection date for primary outcome measure) |
Phase I Dose level A - 9GYx5 Dose level B - 10GYx5 Dose level C - 11GYX5 Dose Level D - 12GYX5
Phase II Deliver maximum tolerated dose from Phase I portion to 43 patients with objective of determining local control rate and patterns of recurrence disease-free and overall survival rates at two years.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Staging studies must identify patient as AJCC Stage I or II based on only 1 of following combinations of TNM staging:
Primary tumor must be arising in one of the following central chest locations:
PRESTUDY REQUIREMENTS:
Exclusion Criteria:
There is no exclusion criteria associated with this protocol. Please see the above inclusion criteria.-
Contact: Jeffrey D. Bradley, MD | (314) 362-8525 | bradley@radonc.wustl.edu |
United States, Missouri | |
Washington University School | Recruiting |
St. Louis, Missouri, United States, 63110 | |
Contact: Jeffrey D Bradley, MD 314-362-8525 bradley@radonc.wustl.edu | |
Contact: Linda M Brockman (314) 454-7986 brockmal@ccadmin.wustl.edu | |
Principal Investigator: Jeffrey D Bradley, MD |
Principal Investigator: | Jeffrey D Bradley, MD | Washington University School of Medicine |
Responsible Party: | Washington University School of Medicine ( Jeffrey Bradley, M.D. ) |
Study ID Numbers: | 06-0691 |
Study First Received: | December 31, 2007 |
Last Updated: | February 3, 2009 |
ClinicalTrials.gov Identifier: | NCT00591838 History of Changes |
Health Authority: | United States: Institutional Review Board |
SBRT |
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 |