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Sponsors and Collaborators: |
Radiation Therapy Oncology Group National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00750269 |
RATIONALE: Stereotactic body radiation therapy may be able to send x-rays directly to the tumor and cause less damage to normal tissue.
PURPOSE: This phase I/II trial is studying the side effects and best dose of stereotactic body radiation therapy and to see how well it works in treating patients with stage I non-small cell lung cancer.
Condition | Intervention | Phase |
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Lung Cancer |
Radiation: stereotactic body radiation therapy |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Seamless Phase I/II Study of Stereotactic Lung Radiotherapy (SBRT) for Early Stage, Centrally Located, Non-Small Cell Lung Cancer (NSCLC) in Medically Inoperable Patients |
Estimated Enrollment: | 94 |
Study Start Date: | February 2009 |
Estimated Primary Completion Date: | May 2012 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study.
Patients undergo stereotactic body radiotherapy every 2 days over 1½-2 weeks (total of 5 fractions) in the absence of disease progression or unacceptable toxicity.
After completion of study therapy, patients are followed periodically.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed non-small cell lung cancer (NSCLC)
Stage T1-2, N0, M0 disease
Hilar or mediastinal lymph nodes ≤ 1 cm AND no abnormal hilar or mediastinal uptake on PET scan are considered N0
Patient deemed "medically inoperable" due to severe underlying physiological medical problems that would prohibit a PCR, including any of the following:
Measurable disease as documented by CT scan or whole-body PET scan within the past 8 weeks
Pleural effusion allowed provided it is deemed too small to tap under CT guidance and is not evident on chest x-ray
PATIENT CHARACTERISTICS:
No other invasive malignancy within the past 2 years except nonmelanomatous skin cancer or carcinoma in situ of the breast, oral cavity, or cervix
PRIOR CONCURRENT THERAPY:
No other concurrent local therapy (including standard-fractionated radiotherapy and/or surgery) or systemic therapy (including standard chemotherapy or biologic targeted agents) specifically intended as treatment for study cancer
Study Chair: | Andrea Bezjak, MD, MSC, FRCPC | Princess Margaret Hospital, Canada |
Investigator: | Jeffrey Bradley, MD | Mallinckrodt Institute of Radiology at Washington University Medical Center |
Investigator: | Laurie E. Gaspar, MD, MBA | University of Colorado at Denver and Health Sciences Center |
Responsible Party: | Radiation Therapy Oncology Group ( Walter John Curran, Jr ) |
Study ID Numbers: | CDR0000613524, RTOG-0813 |
Study First Received: | September 9, 2008 |
Last Updated: | April 14, 2009 |
ClinicalTrials.gov Identifier: | NCT00750269 History of Changes |
Health Authority: | Unspecified |
stage I non-small cell lung cancer |
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 |