Stereotactic Body Radiation Therapy (SBRT) in Metastatic Non-small Cell Lung Cancer
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|ClinicalTrials.gov Identifier: NCT01185639|
Recruitment Status : Completed
First Posted : August 20, 2010
Results First Posted : November 29, 2019
Last Update Posted : November 29, 2019
|Condition or disease||Intervention/treatment||Phase|
|Non-Small-Cell Lung Carcinoma Liver Cancer Adrenal Cancer||Radiation: stereotactic body radiation therapy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||29 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of Stereotactic Body Radiation Therapy (SBRT) After First-Line Chemotherapy for Metastatic NSCLC|
|Actual Study Start Date :||August 2010|
|Actual Primary Completion Date :||June 27, 2016|
|Actual Study Completion Date :||June 27, 2016|
Experimental: SBRT for metastatic NSCLC
SBRT for lung lesions, liver lesions, adrenal lesions, spinal lesions
Radiation: stereotactic body radiation therapy
For lung, liver, axial skeleton, and adrenal tumors a dose of either 54 Gy in 3 fxs or 5000 cGy in 5 fx using SBRT techniques
- Progression-free Survival [ Time Frame: up to 2 years ]Actuarial progression-free survival will be determined using the product-limit method of Kaplan and Meier and will be reported with an exact 95% confidence interval. Using the RECIST criteria including progression of the protocol treated tumors, non-protocol treated tumors and the development of new metastatic disease. Only protocol treated tumors will be determined by RECIST defined as complete lesion disappearance or <25%or original size; partial >30% decrease of target lesion; stable <30% decreased of target lesion and; local failure increase >20% of target lesion. Non-protocol tumor progression will be determined by the treating physician. Measured by imaging every 3 months.
- To Assess Physical Function for This Cohort of Patients [ Time Frame: up to 3 months after treatment ]Using the Vulnerable Elders Survey (VES-13) A 13-item self-reporting questionnaire includes age, self-rated health, limitations in physical function and disability to assess for deterioration of physical function/health. Scoring for the VES-13 is as follows: Total scores are summed together based on self-rated health (0-1), physical function (0-2), functional disability (0-4), (range from 0 to 7). A total score of 3 or more identifies participants as vulnerable to the risk of decline of physical function.
- Number of Participants With Local Control [ Time Frame: up to 2 years ]Local control (LC) of SBRT-treated lesions will only be assessed in patients with at least 4-months of radiographic follow-up.
- Overall Survival [ Time Frame: up to 4 years ]Overall survival will be reported with an exact 95% confidence interval.
- Impact of Treatment on Quality of Life (FACT-L) [ Time Frame: up to 3 months after treatment ]Using the Functional Assessment of Cancer Therapy - Lung (FACT-L) a 36-item self-administered questionnaire evaluating physical, social/family, emotional, and functional well-being; subscales (symptoms, cognitive function, regret of smoking) on a five-point scale from 0 (not at all) to 4 (very much). Maximum score 136. Subscale scores added to obtain total score. The higher the score the greater the impact on the quality of life.
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): NCT01185639
|United States, North Carolina|
|Coastal Carolina Radiation Oncology|
|Wilmington, North Carolina, United States, 28401|
|Wake Forest University Health Sciences|
|Winston-Salem, North Carolina, United States, 27157|
|Principal Investigator:||William Blackstock, MD||Wake Forest University Health Sciences|