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

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.

Study Overview

• Status: Recruiting
• Conditions: Lung Cancer; Early-Stage Lung Cancer
• Intervention / Treatment: Radiation: Stereotactic Body Proton Therapy

• Study Type: Interventional
• Enrollment (Estimated): 65
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Taize Yuan Professor, Doctor; Phone Number: 8620-32506160; Email: taize.yuan@ccm.cn

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China
      • Recruiting
      • Guangzhou Concord Cancer Center
      • Contact: Juan Nie; Phone Number: 8620-32506195; Email: juan.nie@ccm.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. .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.
2. The clinical staging based on positron emission tomography(PET)-computer tomography(CT) examination is: cT1~3 N0M0, stage IA-IIB (AJCC eighth edition).
3. Age: 18 years and above.
4. Karnofsky(KPS) score ≥60.
5. The doctor assesses that surgical treatment is not suitable or the patient refuses surgery.
6. Relatively good organ function:
7. Normal bone marrow function: white blood cell (WBC)≥3×109/L, Platelet ≥80×109/L, Hemoglobin(HGB)≥90g/L
8. Normal liver and kidney function:
9. Total bilirubin, Aspartate Aminotransferase(AST), and ALT(Alanine Aminotransferase)≤2.0×upper limit of normal values;
10. Creatinine clearance ≥60ml/min or creatinine ≤1.5×upper limit of normal value
11. 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:

1. Patients with other malignant tumors.
2. Poorly controlled heart failure, respiratory failure, heart function, and lung function below grade 3 (including grade 3).
3. Those whose laboratory test values do not meet relevant standards before enrollment.
4. Patients who cannot cooperate with regular follow-up due to psychological, social, family and geographical reasons.
5. Women of childbearing age who have a positive pregnancy test and women who are breastfeeding.
6. Patients considered inappropriate for inclusion by other investigators.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Stereotactic Body Proton Therapy; 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.

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.; Other Names: proton hypofractionated radiotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-free Survival	Progression Free Survival(PFS) is defined as time from initiation of SBPT to disease progression or death from any cause. Estimated by the Kaplan-Meier method	Up to 3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Local Control Rate	Local control rate is defined as the proportion of participants with the absence of local failure among patients evaluable for efficacy in three years.	Up to 3 years
Overall Survival	Overall Survival (OS) is defined as time from initiation of SBPT to patient death from any cause. Estimated by the Kaplan-Meier method.	UP to 3 years
Quality of life scores	European Organisation for Research and Treatment of Cancer quality of life questionnaire-core 30 (EORTC QLQ-C30) (V3.0) scores before treatment, weekly during treatment, at the end of treatment, and at each follow-up visit	Up to 3 years
Quality of life scores	European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Lung Cancer Module 29(EORTC QLQ-LC29) scores before treatment, weekly during treatment, at the end of treatment, and at each follow-up visit	Up to 3 years
Rate of grade 3-5 adverse events	The proportion of subjects with toxic reactions of levels 3, 4 and 5 during the clinical trial period.The researchers record adverse events(AE) that appeared during the clinical trial cycle and grade it according to Common Terminology Criteria for Adverse Events (CTCAE) 5.0	Up to 3 years

Collaborators and Investigators

• Sponsor: Guangzhou Concord Cancer Center
• Investigators: Study Chair: Taize Yuan, Doctor, Guangzhou Concord Cancer Center,Guangzhou, Guangdong

Study record dates

Study Major Dates

• Study Start (Actual): February 24, 2026
• Primary Completion (Estimated): July 1, 2029
• Study Completion (Estimated): July 1, 2029

Study Registration Dates

• First Submitted: February 9, 2026
• First Submitted That Met QC Criteria: February 9, 2026
• First Posted (Actual): February 17, 2026

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: May 19, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: lung cancer; radiotherapy; hypofractionated radiotherapy; Proton therapy; Early-Stage Lung Cancer; SBPT
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: 2025-IIT-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Yes. I plan to share relevant non-confidential research progress and academic achievements of this IPD with peer researchers through academic exchanges and academic conferences, while strictly keeping core confidential data undisclosed to comply with clinical research confidentiality rules.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No