A Single-Center, Prospective Phase II Clinical Study of Stereotactic Body Proton Therapy (SBPT) for Early-Stage Non-Small Cell Lung Cancer
This study included patients with early-stage lung cancer cT1-3N0M0, stage IA-IIB (American Joint Committee on Cancer eighth edition staging, AJCC 8th ) who were inoperable or refused surgery. They were divided into peripheral type and central type according to the tumor location and received radical Stereotactic Body Proton Therapy (SBPT) for Early-Stage Non-Small Cell Lung Cancer. The prescribed dose for patients with peripheral lung cancer is 48-60Gray(Gy) (Relative Biological Effectiveness, RBE)/4-6 fractions, and for patients with central lung cancer, the prescribed dose is 50-70Gy(RBE)/10-15 fractions. After treatment, follow-up visits will be conducted to observe short-term and long-term efficacy, adverse reactions and patient quality of life.
• .Lung cancer confirmed by histology and/or cytology; and in the absence of pathological diagnosis, patients who meet the following conditions can also be included: diagnosed by more than 2 imaging modalities, and the clinical diagnosis of lung cancer is confirmed after multidisciplinary team (MDT) discussion.
• The clinical staging based on positron emission tomography(PET)-computer tomography(CT) examination is: cT1\
‣ 3 N0M0, stage IA-IIB (AJCC eighth edition).
• Age: 18 years and above.
• Karnofsky(KPS) score ≥60.
• The doctor assesses that surgical treatment is not suitable or the patient refuses surgery.
• Relatively good organ function:
• Normal bone marrow function: white blood cell (WBC)≥3×109/L, Platelet ≥80×109/L, Hemoglobin(HGB)≥90g/L
• Normal liver and kidney function:
• Total bilirubin, Aspartate Aminotransferase(AST), and ALT(Alanine Aminotransferase)≤2.0×upper limit of normal values;
⁃ Creatinine clearance ≥60ml/min or creatinine ≤1.5×upper limit of normal value
⁃ The patient has signed an informed consent form and is willing and able to comply with planned study visits, treatment plans, laboratory tests, and other study procedures.