Status:
ENROLLING_BY_INVITATION
Personalized SBRT in Early-Stage Peripheral NSCLC
Lead Sponsor:
Tianjin Medical University Cancer Institute and Hospital
Conditions:
Early-stage Peripheral Non-small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This study aims to learn about the long-term safety and effectiveness of personalized stereotactic body radiotherapy (SBRT) in patients with early-stage peripheral non-small cell lung cancer (NSCLC). ...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Participant or legal guardian provides written informed consent.
- Age ≥18 years; no upper age limit; male or female.
- Pathologically confirmed non-small-cell lung cancer (NSCLC) staged T1-2N0M0 (IA-IIA, AJCC 8th ed.).
- Peripheral tumor location: ≥2 cm from the proximal bronchial tree or any mediastinal structure.
- Medically inoperable (e.g., FEV1 \<40 % predicted, DLCO \<40 % predicted, NYHA class III-IV heart failure) or refusal of surgery.
- ECOG performance status 0-2.
- Life expectancy ≥6 months per investigator judgment.
- Measurable disease by RECIST 1.1.
- Adequate organ function (blood counts, liver and renal indices) per institutional standards.
- Willing and able to comply with all study procedures, imaging schedules, and follow-up visits.
- Effective contraception for women of child-bearing potential and fertile men for 12 months after SBRT completion.
- Exclusion Criteria
- Previous thoracic radiotherapy, chemotherapy, targeted therapy, or surgery for lung cancer.
- Evidence of regional or distant metastases.
- Concurrent or prior malignancy within 5 years (except adequately treated basal-cell carcinoma of skin or carcinoma in situ of cervix).
- Active interstitial pneumonitis, radiation pneumonitis, drug-induced pneumonitis, or clinically significant pulmonary fibrosis.
- Pregnancy, lactation, or planned pregnancy.
- Participation in another interventional clinical trial with an unmet primary endpoint.
- Known psychiatric disorder, substance abuse, or other condition that would impair compliance.
- Contraindication to contrast-enhanced CT or PET-CT imaging.
- Investigator-determined medical, social, or psychological contraindications that could compromise safety or data integrity.
Exclusion
Key Trial Info
Start Date :
August 4 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2029
Estimated Enrollment :
251 Patients enrolled
Trial Details
Trial ID
NCT07167459
Start Date
August 4 2023
End Date
March 1 2029
Last Update
September 11 2025
Active Locations (2)
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1
Tianjin Medical University Cancer Institute and Hospital, Tianjin Key Laboratory of Cancer Prevention and Therapy, Tianjin, Tianjin 300060
Tianjin, Tianjin Municipality, China, 300381
2
Tianjin Medical University Cancer Institute and Hospital, Tianjin Key Laboratory of Cancer Prevention and Therapy, Tianjin, Tianjin 300060
Tianjin, Tianjin Municipality, China