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RAPART in Locally Advanced Non-small Cell Lung Cancer Patients
Sponsor: Capital Medical University
Summary
This is a Phase II/III randomized clinical trial of Radiosensitivity-Assisted Personalized Adaptive Radiotherapy Technology (RAPART) in locally advanced non-small cell lung cancer patients. The main objective is to test the overall improvement of overall survival (OS), progression free survival (PFS), and local progression free survival (LPFS) of unresectable stage III NSCLC under standard and non-standard mixed treatment conditions compared to conventional 60Gy radiotherapy.
Official title: Phase II/III Randomized Clinical Trial of Radiosensitivity-Assisted Personalized Adaptive RadioTherapy (RAPART) in Locally Advanced Non-small Cell Lung Cancer Patients
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
911
Start Date
2025-02-17
Completion Date
2027-12-30
Last Updated
2025-12-02
Healthy Volunteers
No
Interventions
Radiosensitivity-Assisted Personalized Adaptive Radiotherapy Technology（RAPART)）
RAPART technology is a special combination of ART and RAPRT, with a total course limit of no more than 30 exposures. The entire course of treatment can be divided into two stages: the first stage is completely the same as the conventional radiotherapy group, with a total of 23 doses of 2 Gy per session. The second stage is the combination of ART and PAPRT. ART uses a CT or PET/CT localization simulation to be performed again during the course of treatment (usually after completing the first part of 17-19 exposures) to generate a new adaptive plan, and after completing the first stage of 23 exposures, treatment is carried out according to the new adaptive plan. RAPAT uses ERCC1/2 biomarkers to predict the patient's radiation sensitivity and determine individualized radiation dose accordingly. ERCC1/2 biomarkers divided patients into 5 different radiosensitivity groups, corresponding to 5 different radiation doses (74, 66, 62, 54, and 50 Gy).
Conventional radiotherapy
conventional radiotherapy
Locations (1)
University of Hong Kong Shenzhen Hospital
Shenzhen, Guangdong, China