Clinical trial NCT05802641: Stereotactic Radiotherapy With Different Fractionation Modes for the Early Lung Cancer
Official title: Clinical Study of Stereotactic Radiotherapy With Different Fractionation Modes for Early Lung Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Lung Cancer
Radiotherapy
Stereotactic Body Radiotherapy
Fractionation
Keywords: lung cancer
Stereotactic body radiotherapy
Fractionation
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2023-04-06
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief summary: 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: 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.

Eligibility criteria: Inclusion Criteria:

1. Signed written informed consent;
2. Male or female aged ≥ 18 years and ≤ 75 years;
3. patients with early lung cancer confirmed by pathology or clinical multidisciplinary team (MDT);
4. The ECOG PS was 0 to 1;
5. Survival time ≥3 months;
6. Laboratory results during screening must meet the following requirements:

   1. 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);
   2. 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.
   3. 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;
   4. 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:

1. 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;
2. 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;

Primary outcomes:
measure: PFS
timeFrame: 2025-01-01
Secondary outcomes:
measure: OS
timeFrame: 2025-01-01
measure: AE
timeFrame: 2025-03-21
Other outcomes:
Locations:
city: Peking
country: China
facility: Department of radiation oncology, Peking University Third Hospital
state: Beijing
Study officials:
affiliation: Department of Peking University Third Hospital
name: Hongqing Zhuang, M.D.
role: PRINCIPAL_INVESTIGATOR
References: