Single Ultra-high Dose Stereotactic Body Radiation Therapy for Early Lung Cancer

Launched by PEKING UNIVERSITY THIRD HOSPITAL · Mar 26, 2023

Keywords

ClinConnect Summary

This clinical trial is exploring a treatment called stereotactic body radiation therapy (SBRT) for patients with early lung cancer. The main goal is to find out how effective and safe this high-dose radiation therapy is for treating this type of cancer. The trial is looking for participants aged between 18 and 75 who have been diagnosed with early-stage lung cancer. To join, patients must be in generally good health, have a good chance of surviving at least three months, and meet certain health criteria related to their blood, liver, and kidney function.

Participants in this trial will receive the SBRT treatment and will be monitored for the effects of the therapy to see how well it works and how it affects their health. It’s important for potential participants to know that they cannot be pregnant, breastfeeding, or currently involved in another clinical trial. This study is currently not recruiting, so it’s a good idea to check back later if someone is interested in participating.

Gender

ALL

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 \< 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;