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Dose-Deescalated 3-Fraction Stereotactic Body Radiotherapy For Centrally Located Lung Cancer

Non-small Cell Lung Cancer Clinical Trial

Official title:
Phase IB/II Trial Of Dose-Deescalated 3-Fraction Stereotactic Body Radiotherapy For Centrally Located Lung Cancer

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04210492
Study type Interventional
Source Yale University
Contact Henry S. Park, MD, MPH
Phone 203-200-2100
Email henry.park@yale.edu
Status Recruiting
Phase Phase 1/Phase 2
Start date March 2, 2020
Completion date January 2030
View Details
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