Locally Advanced Non-small Cell Lung Cancer
Conditions
Brief 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.
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
Sponsors
Capital Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| overall survival | 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
| Measure | Time frame |
|---|---|
| progression-free survival | From enrollment to 3 years after the end of treatment |
| Toxic events | From enrollment to 3 years after treatment |
Countries
China
Contacts
Primary ContactFeng-Ming (Spring) Kong
Outcome results
None listed