Phase I and II Study Of Stereotactic Body Radiotherapy in Medically Unresectable Patients With Stage 1 NSCLC (SBF-NSCLC)
This clinical trial involves a radiation treatment called stereotactic radiotherapy in non-small cell lung cancer patients who have been determined to be ineligible for surgery. This treatment differs from conventional radiotherapy in the number of treatments, the radiation dose given per treatment, and the way the radiation beams are directed toward the cancer.
Non-small Cell Lung Cancer
Procedure: radiation therapy
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase I and II Study Of Stereotactic Body Radiotherapy in Medically Unresectable Patients With Stage 1 NSCLC|
- The purposes of this research study are (1) to find the highest dose of stereotactic radiotherapy that can safely be used for treatment of early stage non-small cell lung cancer. [ Time Frame: 5 years from enrollment completion ] [ Designated as safety issue: Yes ]
- (2) to see what effects (good and bad) stereotactic radiotherapy has on patients and their cancer. [ Time Frame: 5 years from completion enrollment ] [ Designated as safety issue: Yes ]
|Study Start Date:||December 1999|
|Study Completion Date:||August 2012|
|Primary Completion Date:||August 2012 (Final data collection date for primary outcome measure)|
Procedure: radiation therapy
The most common treatment for early stage lung cancers is to remove the cancer with surgery. Patients with serious underlying health problems like emphysema, diabetes, or heart disease who develop an early stage lung cancer may not be eligible for the standard surgical treatment. The most common alternative to surgery is conventional radiation treatment called fractionated radiotherapy. "Fractionated radiotherapy" means several weeks of treatment with daily radiation sessions. While this treatment is sometimes successful at killing the cancer, it is not as effective as surgery and may significantly damage the surrounding lung tissue.
Newer treatments using radiotherapy have been developed and used for patients with metastases (spreading cancer) to the lungs. Stereotactic radiotherapy uses a frame to guide highly focused beams of radiation at the cancer while avoiding the normal surrounding tissue. Stereotactic radiotherapy also uses a higher daily dose of radiation. The higher daily dose may be more effective than conventional radiotherapy at killing cancer cells and may also decrease side effects.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00246181
|United States, Indiana|
|Indiana University, Department of Radiation Oncology|
|Indianapolis, Indiana, United States, 46202|
|Principal Investigator:||Ronald McGarry, MD||Indiana University - Department of Radiation Oncology|
|Principal Investigator:||Achilles Fakiris, MD||Indianan University|