University of Hong Kong Shenzhen Hospital
Shenzhen, Guangdong, 518000, China
Location status: Recruiting
Recruiting
NCT Number: NCT07164885
RAPART in Locally Advanced Non-small Cell Lung Cancer Patients
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.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Adult research participants, aged over 18 years old;
- Non small cell lung cancer that requires pathological confirmation;
- All stage 3 unresectable non-small cell lung cancer, including stage correction after MDT and stage downgrading after treatment (4 → 3), and stage upregulation due to disease progression (2 → 3);
- ECOG physical condition is 0-2;
- In addition to study participants who have not received any treatment, study participants who have undergone surgery, chemotherapy, immunotherapy, and targeted therapy are also eligible for enrollment.
Exclusion criteria
- Prisoners who are not convenient for close clinical follow-up;
- Study participants with contraindications to radiation therapy.
Treatment and study plan
Radiosensitivity-Assisted Personalized Adaptive Radiotherapy Technology（RAPART)）
RadiationRAPART 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
Radiationconventional radiotherapy
Primary outcomes
-
overall survival
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Secondary outcomes
-
progression-free survival
Time frame: From enrollment to 3 years after the end of treatment
-
Toxic events
Time frame: From enrollment to 3 years after treatment
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
Capital Medical University
Other
Registry information
Official study title
Phase II/III Randomized Clinical Trial of Radiosensitivity-Assisted Personalized Adaptive RadioTherapy (RAPART) in Locally Advanced Non-small Cell Lung Cancer Patients
Important dates
- Study start
- 2025
- Primary completion
- 2027
- Study completion
- 2027
- First posted
- Sep 10, 2025
- Registry last updated
- Dec 2, 2025
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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