Image

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

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

Recruiting
18 years and older
All
Phase N/A

Powered by AI

Overview

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.

Eligibility

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 details
    Early-Stage Lung Cancer
    Lung Cancer

NCT07412327

Guangzhou Concord Cancer Center

27 June 2026

Step 1 Get in touch with the nearest study center
We have submitted the contact information you provided to the research team at {{SITE_NAME}}. A copy of the message has been sent to your email for your records.
Would you like to be notified about other trials? Sign up for Patient Notification Services.
Sign up

Send a message

Enter your contact details to connect with study team

Investigator Avatar

Primary Contact

  Other languages supported:

First name*
Last name*
Email*
Phone number*
Other language

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.