RecruitingNot ApplicableNCT07164885

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

Sponsor

Capital Medical University

Enrollment

911 participants

Start Date

Feb 17, 2025

Study Type

INTERVENTIONAL

Conditions

Locally Advanced Non-Small Cell Lung Cancer

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This is a registry study collecting real-world data on patients with stage III unresectable non-small cell lung cancer (NSCLC) — the most common type of lung cancer that cannot be removed surgically — to better understand how these patients are treated and how they fare over time. **You may be eligible if...** - You are 18 or older - You have non-small cell lung cancer requiring pathological confirmation - Your cancer is stage III and unresectable (cannot be surgically removed), including cases where the stage was downgraded after treatment or upgraded due to progression - Your physical health level is ECOG 0–2 - Previous surgery, chemotherapy, immunotherapy, or targeted therapy does not disqualify you **You may NOT be eligible if...** - You are unable to attend regular clinical follow-up (e.g., incarcerated) - You have a medical reason you cannot receive radiation therapy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONRadiosensitivity-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).

RADIATIONConventional radiotherapy

conventional radiotherapy