Prospective Phase II Clinical Study of Stereotactic Body Proton Therapy (SBPT) for Lung Cancer

Official title

A Single-Center, Prospective Phase II Clinical Study of Stereotactic Body Proton Therapy (SBPT) for Early-Stage Non-Small Cell Lung Cancer

Overview

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.

Interventions

• Radiation Stereotactic Body Proton Therapy
  They were divided into peripheral type and central type according to the tumor location and received radical SBPT for Early-Stage Non-Small Cell Lung Cancer. . The prescribed dose for patients with peripheral lung cancer is 48-60Gy(RBE)/4-6 fractions, and for patients with central lung cancer, the prescribed dose is 50-70Gy(RBE)/10-15 fractions.

Primary outcome measures

• Progression-free Survival [Time frame: Up to 3 years]

Secondary outcome measures (5)

• Overall Survival [Time frame: UP to 3 years]
• Local Control Rate [Time frame: Up to 3 years]
• Quality of life scores [Time frame: Up to 3 years]
• Quality of life scores [Time frame: Up to 3 years]
• Rate of grade 3-5 adverse events [Time frame: Up to 3 years]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

China · 1 center

• Guangzhou Concord Cancer Center — Guangzhou

Identifiers

NCT: NCT07412327 · 2025-IIT-002

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗