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Trial Title:
Stereotactic Radiotherapy With Different Fractionation Modes for the Early Lung Cancer
NCT ID:
NCT05802641
Condition:
Lung Cancer
Radiotherapy
Stereotactic Body Radiotherapy
Fractionation
Conditions: Official terms:
Lung Neoplasms
Conditions: Keywords:
lung cancer
Stereotactic body radiotherapy
Fractionation
Study type:
Observational [Patient Registry]
Overall status:
Active, not recruiting
Study design:
Time perspective:
Other
Intervention:
Intervention type:
Radiation
Intervention name:
SBRT
Description:
Participants with early lung cancer receive single fraction (30Gy/1f) or multiple
fractions of SBRT（36Gy/3f).
Arm group label:
Multiple fractions of SBRT（36Gy/3f）
Arm group label:
single fraction of SBRT（30Gy/1f）
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.
Criteria for eligibility:
Study pop:
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.
Sampling method:
Non-Probability Sample
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) < on routine urine test;
2+ or 24 h urinary protein quantification < 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;
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Locations:
Facility:
Name:
Department of radiation oncology, Peking University Third Hospital
Address:
City:
Peking
Zip:
100191
Country:
China
Start date:
January 7, 2018
Completion date:
January 2025
Lead sponsor:
Agency:
Peking University Third Hospital
Agency class:
Other
Source:
Peking University Third Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05802641
