Stereotactic Body Radiation Therapy in Treating Patients With Inoperable Stage I or Stage II Non-Small Cell Lung Cancer
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Stereotactic body radiation therapy may be able to deliver x-rays directly to the tumor and cause less damage to normal tissue.
PURPOSE: This phase II trial is studying how well stereotactic body radiation therapy works in treating patients with inoperable stage I or stage II non-small cell lung cancer.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Trial of Stereotactic Body Radiation Therapy (SBRT) in the Treatment of Patients With Medically Inoperable Stage I/II Non-Small Cell Lung Cancer|
- Local Control at 2 Years [ Time Frame: From the start of treatment to 2 years ] [ Designated as safety issue: No ]Local control is defined as absence of local failure. (Detailed criteria for local failure is too long to include here.)
- Treatment-related Grade 3 or 4 Toxicity [ Time Frame: From the start of treatment to end of follow-up ] [ Designated as safety issue: Yes ]
- Rates of Local Recurrence, Regional Recurrence, Disseminated Recurrence, Disease-free and Overall Survival at 2 Years [ Time Frame: From the start of treatment to 2 years ] [ Designated as safety issue: No ]
|Study Start Date:||May 2004|
|Primary Completion Date:||March 2010 (Final data collection date for primary outcome measure)|
Experimental: Stereotactic body radiation therapy (SBRT)
20 Gy per fraction for 3 fractions over 1.5-2 weeks, for a total of 60 Gy
|Radiation: stereotactic body radiation therapy|
- Determine whether treatment with stereotactic body radiotherapy results in acceptable local control (i.e., ≥ 80%) in patients with medically inoperable stage I or II non-small cell lung cancer.
- Determine treatment-related toxicity in patients treated with this therapy.
- Determine disease-free survival, overall survival, and patterns of failure in patients treated with this therapy.
OUTLINE: This is a multicenter study.
Patients receive 3 fractions of stereotactic body radiotherapy over 8-14 days in the absence of disease progression or unacceptable toxicity.
Patients are followed up at 6 and 12 weeks, every 3 months for 2 years, every 6 months for 2 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 52 patients will be accrued for this study within 26 months.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00087438
|United States, New York|
|James P. Wilmot Cancer Center at University of Rochester Medical Center|
|Rochester, New York, United States, 14642|
|United States, Texas|
|M.D. Anderson Cancer Center at University of Texas|
|Houston, Texas, United States, 77030-4009|
|Principal Investigator:||Robert D. Timmerman, MD||Simmons Cancer Center|