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

NCT07412327 | Recruiting

• 1 other identifier: 2025-IIT-002
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Early-Stage Lung Cancer; Lung Cancer

Keywords

Proton therapy; hypofractionated radiotherapy; radiotherapy; Early-Stage Lung Cancer; lung cancer; SBPT

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Overall Survival

  UP to 3 years

• Local Control Rate

  Up to 3 years

• Quality of life scores

  Up to 3 years

• Quality of life scores

  Up to 3 years

• Rate of grade 3-5 adverse events

  Up to 3 years

Study Arms (1)

Stereotactic Body Proton Therapy

EXPERIMENTAL

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

Interventions

Stereotactic Body Proton Therapy RADIATION

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.

Also known as: proton hypofractionated radiotherapy

Stereotactic Body Proton Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Guangzhou Concord Cancer Center: lead

Study Sites (1)

Guangzhou Concord Cancer Center

Guangzhou, Guangdong, China

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Taize Yuan, Doctor

  Guangzhou Concord Cancer Center,Guangzhou, Guangdong

  STUDY CHAIR

Central Study Contacts

Taize Yuan Professor, Doctor

CONTACT

8620-32506160; taize.yuan@ccm.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2026
• First Posted: February 17, 2026
• Study Start: February 24, 2026
• Primary Completion (Estimated): July 1, 2029
• Study Completion (Estimated): July 1, 2029
• Last Updated: May 22, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)