Radiosensitivity-guided personalized adaptive radiotherapy for locally advanced non-small cell lung cancer
Phase II/III Randomized Clinical Trial of Radiosensitivity-Assisted Personalized Adaptive RadioTherapy (RAPART) in Locally Advanced Non-small Cell Lung Cancer Patients
This trial will test whether a radiosensitivity-guided personalized adaptive radiotherapy approach (RAPART) can improve survival for adults with unresectable locally advanced non-small cell lung cancer compared with standard 60 Gy radiotherapy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 911 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Capital Medical University Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy, radiation |
| Locations | 1 site (Shenzhen, Guangdong) |
| Trial ID | NCT07164885 on ClinicalTrials.gov |
What this trial studies
This is a randomized Phase II/III trial comparing Radiosensitivity-Assisted Personalized Adaptive Radiotherapy Technology (RAPART) against conventional 60 Gy radiotherapy in unresectable stage III non-small cell lung cancer. RAPART uses radiosensitivity information to tailor radiation planning and adapt treatment over time, and participants may receive standard or mixed treatment combinations according to protocol. Primary outcomes include overall survival, progression-free survival, and local progression-free survival, with inclusion of patients who have had prior surgery, chemotherapy, immunotherapy, or targeted therapy. The trial is conducted at University of Hong Kong Shenzhen Hospital and enrolls adults with ECOG 0-2.
Who should consider this trial
Good fit: Adults aged 18 or older with pathologically confirmed unresectable stage III non-small cell lung cancer and ECOG performance status 0–2, including those who have received prior surgery, chemotherapy, immunotherapy, or targeted therapy, are eligible.
Not a fit: Patients with contraindications to radiation therapy, those not suitable for close clinical follow-up (such as incarcerated individuals), or those with resectable disease or ECOG >2 are not expected to benefit from participation.
Why it matters
Potential benefit: If successful, RAPART could increase overall and progression-free survival and improve local tumor control by tailoring radiation to tumor radiosensitivity while potentially limiting normal-tissue toxicity.
How similar studies have performed: Adaptive and biologically guided radiotherapy approaches have shown promising signals in early-phase studies, but large randomized phase III evidence for radiosensitivity-guided personalization in stage III NSCLC is still limited.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Shenzhen, Guangdong
- University of Hong Kong Shenzhen Hospital — Shenzhen, Guangdong, China (Recruiting)
Study contacts
- Study coordinator: Feng-Ming (Spring) Kong
- Email: kong0001@hku.hk
- Phone: +86 188 0755 0703
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.