Stereotactic Body Proton Therapy for Early-Stage Lung Cancer in Inoperable or Surgery-Refusing Patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This prospective interventional study uses hypofractionated stereotactic body proton therapy (SBPT) to treat patients with early-stage NSCLC (cT1-3 N0M0, stage IA-IIB) who are inoperable or refuse surgery. Patients are categorized as peripheral or central tumor types and receive SBPT with dose regimens of 48-60 Gy(RBE) in 4-6 fractions for peripheral tumors or 50-70 Gy(RBE) in 10-15 fractions for central tumors. The trial aims to observe short-term and long-term efficacy, adverse events, and quality of life through post-treatment follow-up. Outcomes will inform feasibility, safety, and potential benefits of SBPT in this patient population.

Why it matters

Who can join: the full rules

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.

Where it's running

• Guangzhou Concord Cancer Center
  Guangzhou, Guangdong, China Recruiting

Study contacts

• Study coordinator: Taize Yuan Professor, Doctor
• Email: taize.yuan@ccm.cn
• Phone: 8620-32506160

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Zipalertinib vs placebo after surgery for uncommon EGFR-mutant NSCLC

  This study tests whether zipalertinib can help people with early-stage, surgically removed NSCLC that has uncommon EGFR mutations-by comparing it to placebo.

  Recruiting at 108 sites Phase 3 Taiho Oncology, Inc. · Anchorage, Alaska and 252 other locations · NCT07128199

• ePRO in advanced lung cancer: emotional distress, brain metastasis, and symptom burden

  This study tests how patients with advanced lung cancer—some with brain metastases—report emotional distress and symptoms over time using electronic questionnaires.

  Recruiting Tongji Hospital · Hubei, Wuhan · NCT07912190

• Urine VOC Test to Detect Lung Cancer in Never Smokers

  A urine test that looks for volatile compounds is tested to see if it can help detect lung cancer in adults who have never smoked.

  Recruiting Thomas Jefferson University · Philadelphia, Pennsylvania · NCT07871656

• SI-B036 safety test in advanced and metastatic solid tumors

  This early-phase study checks whether SI-B036 is safe and tolerable in adults with advanced or metastatic solid cancers who have had prior therapy.

  Recruiting at 4 sites Phase 1 SystImmune Inc. · New Haven, Connecticut and 6 other locations · NCT07857616

• Guaraná Supplement for Cancer-Related Fatigue in People Undergoing Treatment

  This study tests whether taking guaraná capsules helps reduce cancer-related fatigue and improve quality of life in adults with breast, lung, colorectal, or gastric cancer who are actively receiving treatment.

  Recruiting Centro de Tratamiento e Investigación sobre Cáncer, Luis Carlos Sarmiento Angulo · Bogotá, Bogota D.C. · NCT07816263

• ENPP1/cGAS and FAP in Solid Tumors in Vietnamese Patients

  This Vietnam-based study will test ENPP1, cGAS, and FAP expression in archived tumor samples from Vietnamese adults with solid cancers using immunohistochemistry.

  Recruiting at 2 sites Tam Anh Research Institute · Hanoi, Hanoi and 1 other locations · NCT07808164

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.