Stereotactic Radiotherapy With Different Fractionation Modes for the Early Lung Cancer

Study Overview
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Brief Summary
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The goal of this observational study is to study the efficacy and safety of stereotactic body radiotherapy (SBRT) with different fractionation modes for early lung cancer. The main questions it aims to answer are: How effective are different regimens of SBRT for early lung cancer? How safe are different regimens of SBRT of SBRT for early lung cancer?

Detailed Description
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The goal of this observational study is to study the efficacy and safety of stereotactic body radiotherapy (SBRT) with different fractionation modes for early lung cancer.. This study intends to review the patients with early lung cancer receiving SBRT of 30Gy/1f or 36Gy/3f from 2018 to 2024 in our center.

Official Title
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Clinical Study of Stereotactic Radiotherapy With Different Fractionation Modes for Early Lung Cancer

Conditions
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Lung Cancer, Radiotherapy, Stereotactic Body Radiotherapy, Fractionation

Intervention / Treatment
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* Radiation: SBRT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Signed written informed consent; Male or female aged ≥ 18 years and ≤ 75 years; patients with early lung cancer confirmed by pathology or clinical multidisciplinary team (MDT); The ECOG PS was 0 to 1; Survival time ≥3 months; Laboratory results during screening must meet the following requirements: Blood routine: neutrophil absolute count (ANC) ≥ 1.5 × 109/L, platelet count (PLT) ≥ 100 × 109/L, hemoglobin (HGB) ≥ 90 g/L (no blood transfusion or erythropoietin dependence within 7 days); Liver function: total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal value (ULN); Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) were less than 2.5 times ULN in subjects without liver metastasis, and ALT and AST were less than 5 times ULN in subjects with liver metastasis. Renal function: serum creatinine (Cr) ≤1.5 times ULN or Cr clearance ≥60 mL/min (Cockcroft-Gault formula), and urine protein (UPRO) &lt on routine urine test; 2+ or 24 h urinary protein quantification &lt; 1g; International standardized ratio (INR) ≤1.5 times ULN and partial prothrombin time (PTT) or activated partial thrombin time (APTT) ≤1.5 times ULN during the 7 days prior to treatment; Exclusion Criteria: any unstable systemic disease, including but not limited to active infection, congestive heart failure [New York Heart Association (NYHA) class ≥ II], severe arrhythmia requiring medical therapy, liver, kidney, or metabolic disease; Type I and type II respiratory failure; other malignancies within 5 years before randomization, except adequately treated cervical carcinoma in situ, basal cell or squamous skin cancer, local prostate cancer after radical surgery, ductal carcinoma in situ after radical surgery, or papillary thyroid cancer;

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| single fraction of SBRT（30Gy/1f）<br>Participants with early lung cancer receive single fraction of SBRT（30Gy/1f). | Radiation: SBRT<br>* Participants with early lung cancer receive single fraction (30Gy/1f) or multiple fractions of SBRT（36Gy/3f).<br>|
| Multiple fractions of SBRT（36Gy/3f）<br>Participants with early lung cancer receive multiple fractions of SBRT（36Gy/3f). | Radiation: SBRT<br>* Participants with early lung cancer receive single fraction (30Gy/1f) or multiple fractions of SBRT（36Gy/3f).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PFS | The time from the date of treatment to the date of disease progression or death or last follow-up. | 2025-01-01 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| OS | The time from the date of treatment to the date of death or last follow-up. | 2025-01-01 | 
| AE | The incidence of All adverse event (AE), treatment emergent AE (TEAE), treatment-related AE (TRAE), serious AE (SAE) and radiation-related AE(rAE), the relevance and severity related with the study protocol. | 2025-03-21 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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lung cancer, Stereotactic body radiotherapy, Fractionation