Actively Recruiting
Phase II/III Randomized Clinical Trial of Radiosensitivity-Assisted Personalized Adaptive Radiotherapy (RAPART) in Locally Advanced Non-small Cell Lung Cancer Patients
Led by Capital Medical University · Updated on 2025-12-02
911
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating Radiosensitivity-Assisted Personalized Adaptive Radiotherapy Technology (RAPART) in patients with locally advanced non-small cell lung cancer (NSCLC) that cannot be removed by surgery. This Phase II/III randomized clinical trial aims to compare overall survival, progression-free survival, and local progression-free survival between RAPART and conventional 60 Gy radiotherapy. The study focuses on unresectable stage III NSCLC and explores how personalized radiation doses based on biomarker sensitivity may improve outcomes. The trial includes two treatment groups: one receiving RAPART technology and the other receiving conventional radiotherapy with 2 Gy per fraction. RAPART combines adaptive radiotherapy (ART) and radiosensitivity-assisted personalized radiotherapy (RAPRT) over no more than 30 treatment sessions. The first stage matches conventional radiotherapy with 23 doses of 2 Gy each. After 17-19 doses, imaging is repeated to create a new adaptive plan for the second stage. RAPRT uses ERCC1/2 biomarkers to categorize patients into five radiosensitivity groups, each receiving a different radiation dose (74, 66, 62, 54, or 50 Gy). Participants will be monitored from randomization up to 100 months for overall survival and for three years after treatment for progression-free survival and toxic events. The study involves regular imaging and clinical assessments to track disease progression and side effects. Researchers will evaluate how personalized radiation dosing affects survival and safety compared to standard radiotherapy. The trial is sponsored by Capital Medical University and includes adults aged 18 and older with stage III unresectable NSCLC.
CONDITIONS
Brief Title
RAPART in Locally Advanced Non-small Cell Lung Cancer Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult research participants, aged over 18 years old
- Pathologically confirmed non-small cell lung cancer
- Unresectable stage III non-small cell lung cancer, including stage changes after multidisciplinary team review or treatment
- ECOG physical condition score between 0 and 2
- Participants may be treatment-naive or have undergone surgery, chemotherapy, immunotherapy, or targeted therapy
You will not qualify if you...
- Prisoners who cannot be closely followed clinically
- Participants with contraindications to radiation therapy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Duration of radiotherapy course with up to 30 exposures
Participants receive personalized adaptive radiotherapy or conventional radiotherapy based on their assigned group. Treatment involves up to 30 exposures divided into two stages, including adaptive planning and dosing based on radiosensitivity.
Approximately 30 treatment visits
Trial Site Locations
Total: 1 location
1
University of Hong Kong Shenzhen Hospital
Shenzhen, Guangdong, China, 518000
Actively Recruiting
Research Team
F
Feng-Ming (Spring) Kong
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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