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Proton Radiation Therapy for Early-Stage Non-Small Cell Lung Cancer

Tests focused proton radiation in adults with early lung cancer who cannot or decline surgery.

Key facts

Who runs it
Guangzhou Concord Cancer Center
Where
Guangzhou, ChinaSee the site
Trial code
Registry title
Prospective Phase II Clinical Study of Stereotactic Body Proton Therapy (SBPT) for Lung Cancer
Status
Recruiting
People taking part
65 people, planned
Started
24 Feb 2026
Expected to end
1 Jul 2029
Type of study
Interventional
Treatments tested
  • Stereotactic Body Proton Therapy
Record updated
22 May 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with early-stage lung cancer who cannot have surgery or refuse it. They would receive proton radiation therapy.

Age
18 years and above
Sex
All sexes
Disease stage
Early-stage lung cancer, cT1-3 N0M0, stage IA-IIB (AJCC eighth edition), confirmed by tissue tests or by imaging and a team discussion
Earlier treatment
The doctor judges that surgery is not possible, or the patient refuses surgery

Main reasons for not taking part

  • Other malignant tumors
  • Poorly controlled heart failure or respiratory failure, or heart or lung function at grade 3 or below
  • Laboratory test values that do not meet the study standards
  • Cannot attend regular follow-up for psychological, social, family or geographical reasons
  • Positive pregnancy test or breastfeeding

The registry criteria, word for word

Show all 17 criteriaShow less

Who can take part

  • .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

Who cannot take part

  • 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
  • Women of childbearing age who have a positive pregnancy test and women who are breastfeeding
  • Patients who cannot cooperate with regular follow-up due to psychological, social, family and geographical reasons
  • Patients considered inappropriate for inclusion by other investigators

Where in China

  • Guangzhou Concord Cancer CenterGuangzhou, ChinaContact: Juan NieTaking people

About the trial

What the trial wants to find out

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.

The group in the trial

  • Stereotactic Body Proton TherapyTreatment being tested

    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.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
A Single-Center, Prospective Phase II Clinical Study of Stereotactic Body Proton Therapy (SBPT) for Early-Stage Non-Small Cell Lung Cancer
Plain-language title
Proton Radiation Therapy for Early-Stage Non-Small Cell Lung CancerGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
22 May 2026