Clinical trial NCT05802654: Single Ultra-high Dose Stereotactic Body Radiation Therapy for Early Lung Cancer
Official title: Clinical Study of Single Ultra-high Dose Stereotactic Body Radiation Therapy for Early Lung Cancer
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Early Lung Cancer
Stereotactic Body Radiotherapy
Keywords: lung cancer
Stereotactic body radiotherapy (SBRT)
High dose
Fraction
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
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: single fraction of ultra-high dose SBRT
Primary purpose: TREATMENT

Brief summary: The goal of this prospective single-arm phase II study is to study the efficacy and safety of stereotactic body radiotherapy (SBRT) for early lung cancer. The main questions it aims to answer are:

How effective is this regimen of SBRT for early lung cancer? How safe is this regimen of SBRT for early lung cancer?

Detailed description: The goal of this prospective single-arm phase II study is to study the efficacy and safety of stereotactic body radiotherapy (SBRT) for early lung cancer. This study intends to enroll 100 participants in 2 years. The participants enrolled will receive single fraction of ultra-high dose stereotactic body radiotherapy (SBRT) (30Gy/1F).

Eligibility criteria: Inclusion Criteria:

1. Signed written informed consent;
2. Male or female aged ≥ 18 years and ≤ 75 years;
3. patients with early stage lung cancer confirmed by pathology or clinical MDT;
4. The physical state score (ECOG PS) of the eastern tumor cooperative group was 0 \~ 1;
5. Expected 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;
7. For female subjects of reproductive age, urine or serum pregnancy tests should be negative within 3 days prior to receiving the first fraction of SBRT. If the urine pregnancy test results cannot be confirmed negative, a blood pregnancy test is requested;
8. Compliance with the research protocol is expected to be good.

Exclusion Criteria:

1. currently participating in an interventional clinical trial;
2. 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;
3. 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;
4. women who are pregnant or breastfeeding or who plan to become pregnant or breastfeeding during the study period;

Primary outcomes:
measure: PFS
timeFrame: 3 years
Secondary outcomes:
measure: OS
timeFrame: 3 years
measure: AE
timeFrame: 3 years
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: STUDY_CHAIR
References: