Prospective Phase II Clinical Study of Stereotactic Body Proton Therapy (SBPT) for Lung Cancer
Recruiting · NCT07412327 · Interventional (participants receive a specific treatment) · Lead sponsor: Guangzhou Concord Cancer Center
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- .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.
Exclusion criteria
- Patients with other malignant tumors.
- Poorly controlled heart failure, respiratory failure, heart function, and lung function below grade 3 (including grade 3).
- Those whose laboratory test values do not meet relevant standards before enrollment.
- Patients who cannot cooperate with regular follow-up due to psychological, social, family and geographical reasons.
- Women of childbearing age who have a positive pregnancy test and women who are breastfeeding.
- Patients considered inappropriate for inclusion by other investigators.
Where it is running
1 location listed.
- Guangzhou Concord Cancer Center - Guangzhou, Guangdong, China