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

Peking University Third Hospital1 site in 1 country100 target enrollmentJanuary 7, 2018

ConditionsLung Cancer Radiotherapy Stereotactic Body Radiotherapy Fractionation

Overview

Phase: N/A
Intervention: Not specified
Conditions: Lung Cancer
Sponsor: Peking University Third Hospital
Enrollment: 100
Locations: 1
Primary Endpoint: PFS
Status: Active, Not Recruiting
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

January 7, 2018

End Date

January 2025

Last Updated

3 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Peking University Third Hospital

Responsible Party

Sponsor

Eligibility Criteria

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 \< 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;