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Study to Evaluate SBRT for EGFR Mutant NSCLC Patients Receiving Osimertinib (CULTRO)
Sponsor: Centro de Tratamiento e Investigación sobre Cáncer, Luis Carlos Sarmiento Angulo
Summary
Phase II Study to Evaluate the Impact of SBRT (Stereotactic Body Radiation Therapy) and/or SRS (Stereotactic Radiosurgery) on Oligoresidual Disease in EGFR Mutation Patients Treated with Osimertinib as First-Line Systemic Intervention. All candidates must exhibit a partial response after 12 weeks of treatment with the third-generation tyrosine kinase inhibitor (alone or in combination with chemotherapy) and a maximum of five (5) residual lesions in a maximum of two (2) organs. The primary outcome will be progression-free survival (PFS), and secondary outcomes will include overall survival (OS), proportion of patients without progression at months 12 and 36, safety, and overall response rate (ORR). Additionally, an exploratory analysis will be conducted on the prognostic value of liquid biopsy (supplementary information), considering baseline presence of mutations (determined by Next Generation Sequencing tests) and reduction or negativization of allelic fraction (AF).
Official title: Phase II Study to Evaluate the Efficacy and Safety of SBRT as an Adjunctive Intervention for Oligoresidual Disease in EGFR Mutant NSCLC With First-Line Osimertinib Treatment
Key Details
Gender
All
Age Range
18 Years - 99 Years
Study Type
INTERVENTIONAL
Enrollment
35
Start Date
2023-11
Completion Date
2028-11
Last Updated
2023-08-21
Healthy Volunteers
No
Conditions
Interventions
Stereotactic Body Radiation Therapy SBRT
This is a non-randomized Phase II study in which all patients receive the experimental treatment with Stereotactic Ablative Radiotherapy (SABR) to residual tumor lesions (up to 5 residual metastatic lesions in a maximum of 2 organs) following 12 weeks of systemic treatment with Osimertinib. The study aims to enroll 35 patients diagnosed and treated at CTIC Centro de Tratamiento e Investigación Sobre Cáncer Luis Carlos Sarmiento Angulo.
Locations (1)
CTIC - Centro de Tratamiento e Investigación Sobre Cáncer Luis Carlos Sarmiento Angulo
Bogotá, Colombia