RAPART in Locally Advanced Non-small Cell Lung Cancer Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Radiosensitivity-Assisted Personalized Adaptive Radiotherapy Technology（RAPART)）, Conventional radiotherapy.
- Who it may be relevant to
- Registry conditions: Locally Advanced Non-small Cell Lung Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Phase II/III Randomized Clinical Trial of Radiosensitivity-Assisted Personalized Adaptive RadioTherapy (RAPART) in Locally Advanced Non-small Cell Lung Cancer Patients
Overview
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
- 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 - Radiation Conventional radiotherapy
conventional radiotherapy
Primary outcome measures
- 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 outcome measures (2)
- 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]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- University of Hong Kong Shenzhen Hospital — Shenzhen
Identifiers
NCT: NCT07164885 · GCOG0058