A Phase 2 interventional study of Stereotactic Body Radiation Therapy (SBRT) in Lung Cancer, sponsored by M.D. Anderson Cancer Center. Completed at 1 site in United States. Per ClinicalTrials.gov, last updated 2020-03-30.
Sponsored by M.D. Anderson Cancer Center · Phase 2, Interventional, and Treatment
The goal of this clinical research study is to learn if stereotactic body radiotherapy (SBRT) can help to control NSCLC. The safety of SBRT will also be studied.
Objectives:
To assess therapeutic efficacy and toxicities of stereotactic body radiotherapy (SBRT) for patients with medically inoperable stage I (T1-2, N0,M0), selective stage II (chest wall T3, N0M0) or isolated peripheral lung recurrent non-small cell lung cancer (NSCLC).
Primary goal: Improve 2 years progression free survival at the treated primary tumor site.
Secondary goals:
Stereotactic body radiotherapy is designed to provide an image guided, more focused, dose escalated radiotherapy over a shorter time frame (1 week rather than 7 weeks) than conventional radiation therapy. The goal of SBRT is to improve tumor control while reducing the side effects.
If you are found to be eligible to take part in this study, you will receive daily SBRT for 4 days in a row over a 45 minute time period. During the treatment, you will lie still on a table for about 45 minutes per day in the same position. The machine will deliver the dose according to the plan developed by the doctor and the dose will be controlled by a computer.
During the treatment, you will be seen by a doctor and research nurse once a week to evaluate possible side effects. A physical exam and a medical history will be done at these visits.
You will be taken off study early if the disease gets worse or intolerable side effects occur.
You will have a follow-up visit 6 weeks after completion of radiotherapy to check for side effects. You will continue to have follow-up visits that will decrease in frequency over time. You will have imaging tests (chest CT or positron emission computed tomography (PET) scan) and routine blood tests (about 2 teaspoons) at these follow-up visits.
This is an investigational study. SBRT is FDA approved for the treatment of lung cancer. About 138 patients will take part in this study. All will be enrolled at MD Anderson.
7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.
This study's enrollment of 141 is above the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.
Browse Lung Neoplasms studies →M.D. Anderson Cancer Center is the lead sponsor of 2,999 studies on the registry; 581 are open to participants now.
Of its 599 completed or terminated interventional studies of FDA-regulated products, 402 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Stereotactic Body Radiation Therapy (SBRT) Stage I NSCLC
Procedure: Stereotactic Body Radiation Therapy (SBRT)
Stereotactic Body Radiation Therapy (SBRT) Selective Stage II NSCLC
Procedure: Stereotactic Body Radiation Therapy (SBRT)
Stereotactic Body Radiation Therapy (SBRT) Isolated Peripheral Lung Recurrent NSCLC
Procedure: Stereotactic Body Radiation Therapy (SBRT)
Cohorts 1 \& 2: 50 gray (GY) with 12.5 GY per Fraction for 4 treatments Cohort 3: 40 GY with 10 GY per Fraction for 4 treatments
Progression Free Survival (PFS) at Treated Primary Tumor Site
Progression free survival at the primary site evaluated by series CT of chest with contrast for every follow up (except 6 weeks after radiotherapy) for two years. PET information considered for calculation of PFS particularly for distant metastasis and/or additional lesions. Population proportion for two-year PFS estimated using Clopper-Pearson 95% confidence intervals.
Time frame: 2 Years
This study is completed, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
M.D. Anderson Cancer Center