Stereotactic Body Radiation Therapy in Treating Patients With Inoperable Stage I or Stage II Non-Small Cell Lung Cancer
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|ClinicalTrials.gov Identifier: NCT00087438|
Recruitment Status : Completed
First Posted : July 12, 2004
Results First Posted : April 7, 2014
Last Update Posted : February 17, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Lung Cancer||Radiation: stereotactic body radiation therapy||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||59 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||May 2004|
|Actual Primary Completion Date :||March 2010|
|Actual Study Completion Date :||December 2016|
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|
- Local Control at 2 Years [ Time Frame: From the start of treatment to 2 years ]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 ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|