NCT07412327Recruiting
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
Source: ClinicalTrials.gov · Last updated 22 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 65 (estimated)
- First submitted
- 9 Feb 2026
- Start date
- 24 Feb 2026
- Primary completion date
- 1 Jul 2029
- Lead sponsor
- Guangzhou Concord Cancer Center
- Diseases
- Lung cancer
- NCT number
- NCT07412327
What you commit to
- Study type: Interventional
- Planned participants: 65
- From 24 Feb 2026 to the primary completion date, 1 Jul 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Patients with other malignant tumors.
- Poorly controlled heart failure, respiratory failure, heart function, and lung function below grade 3 (including grade 3).
Lab values
- Those whose laboratory test values do not meet relevant standards before enrollment.
Age
- Women of childbearing age who have a positive pregnancy test and women who are breastfeeding.
Other
- Patients who cannot cooperate with regular follow-up due to psychological, social, family and geographical reasons.
- Patients considered inappropriate for inclusion by other investigators.
Who the study is looking for
- .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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Guangzhou Concord Cancer Center Coordinator of this site? Confirm its status | Guangzhou | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.