This phase IB/II trial studies the safety and effectiveness of dose de-escalated (lower than standard dose) stereotactic body radiation therapy (SBRT) in treating patients with centrally located lung cancer. Stereotactic body radiation therapy is a type of radiation therapy that administers high doses of radiation using several beams of various intensities aimed at different angles to precisely target the tumor. This method may kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. Commonly for patients with centrally located lung tumors, 5 treatment sessions (fractions) of SBRT are required. However, a dose de-escalated regimen (3-fractions) of SBRT may improve patient convenience and quality-of-life.
Additional locations may be listed on ClinicalTrials.gov for NCT04210492.
Locations matching your search criteria
United States
Connecticut
Greenwich
Smilow Cancer Hospital Care Center at GreenwichStatus: Active
Contact: Henry S. Park
Phone: 203-785-2971
Guilford
Smilow Cancer Hospital Care Center - GuilfordStatus: Active
Contact: Henry S. Park
Phone: 203-785-2971
Hamden
Smilow Cancer Hospital-Hamden Care CenterStatus: Active
Contact: Henry S. Park
Phone: 203-785-2971
New Haven
Yale UniversityStatus: Active
Contact: Henry S. Park
Phone: 203-200-2100
Trumbull
Smilow Cancer Hospital Care Center-TrumbullStatus: Active
Contact: Henry S. Park
Phone: 203-785-2971
Waterford
Smilow Cancer Hospital Care Center - WaterfordStatus: Active
Contact: Henry S. Park
Phone: 203-785-2971
PRIMARY OBJECTIVE:
I. To assess the co-primary endpoints of safety and efficacy (defined as local control [LC]) of the proposed 3-fraction regimen.
SECONDARY OBJECTIVES:
I. Lobar control.
II. Regional control.
III. Distant control.
IV. Progression-free survival.
V. Cancer-specific survival.
VI. Overall survival.
EXPLORATORY OBJECTIVES:
I. Investigate the changes in circulating tumor deoxyribonucleic acid (ctDNA) in patient blood.
II. Investigate organs at risk (OAR) dosimetry.
III. Investigate patient-reported-toxicity.
IV. Investigate quality-of-life while receiving radiation and in follow-up.
OUTLINE:
Patients undergo SBRT 2-3 times per week on non-consecutive days for a total of 3 fractions. Treatment is completed within a maximum of 10 days in the absence of disease progression or unacceptable toxicity. Patients also undergo computed tomography (CT) and collection of blood samples prior to SBRT and during follow up.
After completion of study treatment, patients are followed up at 1 month, every 4 months for 1 year, every 6 months up to 5 years, and then annually thereafter.
Lead OrganizationYale University
Principal InvestigatorHenry S. Park