NCT07164885

RAPART in Locally Advanced Non-small Cell Lung Cancer Patients

Phase II/III Randomized Clinical Trial of Radiosensitivity-Assisted Personalized Adaptive RadioTherapy (RAPART) in Locally Advanced Non-small Cell Lung Cancer Patients

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 911 (estimated)
• Sponsor: Capital Medical University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Locally Advanced Non-small Cell Lung Cancer

Interventions

Type	Name	Description
RADIATION	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).
RADIATION	Conventional radiotherapy	conventional radiotherapy

Timeline

• Start date: 2025-02-17
• Primary completion: 2027-12-30
• Completion: 2027-12-30
• First posted: 2025-09-10
• Last updated: 2025-12-02

Locations

1 site across 1 country: China