Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:41 PM
Ignite Modification Date:
2025-12-24 @ 2:41 PM
NCT ID:
NCT07167459
Eligibility Criteria:
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07167459
Study Brief:
Protocol Section:
NCT07167459