Early-Stage Lung Cancer, Lung Cancer
Conditions
Keywords
Proton therapy, hypofractionated radiotherapy, radiotherapy, Early-Stage Lung Cancer, lung cancer, SBPT
Brief summary
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.
Interventions
RADIATIONStereotactic Body Proton Therapy
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.
Sponsors
Guangzhou Concord Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free Survival | 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
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival | 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. |
| Local Control Rate | 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. |
| Quality of life scores | 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 |
| Rate of grade 3-5 adverse events | 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 |
Countries
China
Contacts
CONTACTTaize Yuan Professor, Doctor
STUDY_CHAIRTaize Yuan, Doctor
Guangzhou Concord Cancer Center,Guangzhou, Guangdong
Outcome results
None listed