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NCT Number: NCT07412327

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Guangzhou Concord Cancer Center

Guangzhou, Guangdong, China

Location status: Recruiting

Location contact

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: proton hypofractionated radiotherapy

Primary outcomes

  1. Progression-free Survival

    Time frame: Up to 3 years

    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

Secondary outcomes

  1. Overall Survival

    Time frame: UP to 3 years

    Overall Survival (OS) is defined as time from initiation of SBPT to patient death from any cause. Estimated by the Kaplan-Meier method.

  2. Local Control Rate

    Time frame: Up to 3 years

    Local control rate is defined as the proportion of participants with the absence of local failure among patients evaluable for efficacy in three years.

  3. Quality of life scores

    Time frame: Up to 3 years

    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

  4. Quality of life scores

    Time frame: Up to 3 years

    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

  5. Rate of grade 3-5 adverse events

    Time frame: Up to 3 years

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Taize Yuan Professor, Doctor

CONTACT

[email protected]

8620-32506160

Sponsors and collaborators

Lead sponsor

Guangzhou Concord Cancer Center

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Feb 17, 2026
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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