Seamless Study Of Stereotactic Lung Radiotherapy (SBRT) For Early Stage, Centrally Located, Non-Small Cell Lung Cancer (NSCLC) In Medically Inoperable Patients
| Status: | Archived |
|---|---|
| Conditions: | Lung Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 7/1/2011 |
| Start Date: | January 2009 |
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
The purpose of this study is to test the safety of stereotactic body radiation therapy
(SBRT) at different dose levels with patients who have a centrally located early stage lung
cancer. The usual treatment for early stage lung cancer is to remove the cancer with
surgery. However, some patients cannot have surgery because of medical conditions that deem
them "medically inoperable." These conditions would include (but are not limited to)
emphysema, diabetes or heart disease. This study would use SBRT on this patient population.
The higher dose technique may work more efficiently to kill cancer cells with potentially
fewer side effects than standard radiation therapy.
Patients will receive SBRT for 1.5 to 2 weeks to a centrally-located Non-Small Cell Lung
Cancer tumor. Approximately 1-2 weeks prior to beginning SBRT the patient will require the
placement of 3-6 gold seeds in the tumor area. The first subjects enrolled will begin with
10 Gy/fraction of SBRT every 2 days for a total of 5 fractions. If any dose-limiting
toxicity is reported in any of the subjects receiving this dose, subsequent subjects will
receive the next lowest dose level (9.5 Gy/fraction). If initial subjects tolerate the 10
Gy/fraction dose, subsequent subjects will receive the next highest dose level (10.5
Gy/fraction). After SBRT is completed, the study doctor will ask the patient to visit the
office for follow-up exams at 6 weeks from the start of radiation treatment, every 3 months
in years 1-2, every 6 months in years 3-4, and then once a years for their lifetime.
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