Stereotactic Body Radiation Therapy Clinical Trial
Official title:
The ctDNA for Evaluating Whether to Use Adjuvant Therapy After SBRT in Patients With Early Lung Cancer
The purpose of this study is to determine whether ctDNA could help to evaluate whether to use drug adjuvant therapy after SBRT in patients with early lung cancer.
Status | Not yet recruiting |
Enrollment | 180 |
Est. completion date | May 15, 2027 |
Est. primary completion date | June 15, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | Inclusion Criteria: 1. Patients pathologically diagnosed as non-small cell lung cancer, and was early stage(AJCC 8th); 2. Patients aged between 18 -80 years; with expected survival time>3 months. 3. Patients with normal organ function within 30 days prior to treatment, the following criteria are met: 1. blood routine examination criteria : i) hemoglobin (HB) =90g/L; ii) absolute neutrophil count (ANC) =1.5×10e9/L; iii) platelet (PLT) =80×10e9/L; b) biochemical tests meet the following criteria: i) total bilirubin (TBIL) =1.5 times of upper limit of normal (ULN); ii) alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =2.5 ULN; iii) serum creatinine (Cr) =1.5 ULN or creatinine clearance (CCr) =60mL/min; Exclusion Criteria: 1. Patients with small cell lung cancer (including small cell carcinoma and non-small cell carcinoma mixed lung cancer); 2. Patients with factors that affect oral medication (such as cannot swallow, chronic diarrhea and intestinal obstruction, etc.) or intravenous medication; 3. Patients with any other severe and/or uncontrolled disease; 4. Patients with a history of psychotropic medicine abuse and cannot quit or have mental disorders; 5. Patients with disease which will severely endanger their security and could not complete this study, according to the judgement of researchers; |
Country | Name | City | State |
---|---|---|---|
China | Department of Radiation Oncology Cancer Center, Peking University Third Hospital 49# North Garden Rd.,Haidian Dist. | Beijing | Beijing |
Lead Sponsor | Collaborator |
---|---|
Peking University Third Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | PFS | progression-free survival | 3-year | |
Secondary | PFS | progression-free survival | 5-year | |
Secondary | OS | overall survival | 3-year | |
Secondary | OS | overall survival | 5-year |
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