Phase IB/II Trial Of Dose-Deescalated 3-Fraction Stereotactic Body Radiotherapy For Centrally Located Lung Cancer
Summary
The purpose of this trial is to test a deescalated 3-fraction stereotactic body radiotherapy (SBRT) regimen to 45 Gray (Gy) in 3 fractions for centrally located thoracic tumors.
Detailed description
The purpose of this trial is to test a deescalated 3-fraction SBRT regimen to 45 Gy in 3 fractions for centrally located thoracic tumors in a phase II trial. This will provide prospectively collected data on the safety and efficacy of a three-fraction regimen in the previously defined "No Fly Zone" for both primary non-small cell lung cancer (NSCLC) and for lung metastases of any histology. This registration describes the design and eligibility criteria for the 36 NSCLC subjects the investigators plan to enroll. Local control, cancer-specific survival, and overall survival results from the NSCLC patients will be compared to both 3- and 5-fraction historical controls, specifically RTOG 0236 and 0813 results. The outcomes of the metastatic patients will also be reported. There will also be a quality-of-life component to the study to assess the impact of a shorter overall treatment time and the clinical impact of radiation side effects.
Arms & interventions
- Radiation45 Gray (Gy) regimen
Deescalated 3-fraction stereotactic body radiotherapy regimen to 45 Gy in 3 fractions.
Outcome measures
Primary
Safety of the stereotactic body radiotherapy regimen (SBRT)
Safety will be assessed by acute (defined as within 90 days of stereotactic body radiotherapy (SBRT)) and late (from 91 days through 2 years post-SBRT) toxicities. Toxicities are based on (Common Terminology Criteria for adverse events) CTCAE v. 5 criteria
Time frame: From administration of SBRT up to 2 years post-SBRT
local control (LC) of 3-fraction stereotactic body radiotherapy
The absence of primary tumor failure. Primary tumor failure is defined as Increase in tumor dimension of 20%.
Time frame: Up to 10 years post-enrollment.
Secondary
lobar control
Time frame: Up to 10 years post-enrollment.
regional control
Time frame: Up to 10 years post-enrollment.
distant control
Time frame: Up to 10 years post-enrollment.
overall survival
Time frame: Up to 10 years post-enrollment.
progression-free survival
Time frame: Up to 10 years post-enrollment.
Eligibility criteria
Study locations (6)
Smilow Cancer Hospital Care Center at Greenwich
Greenwich, Connecticut, 06830
Smilow Cancer Hospital Care Center - Guilford
Guilford, Connecticut, 06437
Smilow Cancer Hospital - Hamden Care Center
Hamden, Connecticut, 06518
Smilow Cancer Hospital
New Haven, Connecticut, 06511
Smilow Cancer Hospital Care Center - Trumbull
Trumbull, Connecticut, 06611
Smilow Cancer Hospital Care Center - Waterford
Waterford, Connecticut, 06385