Status:
NOT_YET_RECRUITING
The ctDNA for Evaluating Whether to Use Adjuvant Therapy After SBRT in Patients With Early Lung Cancer
Lead Sponsor:
Peking University Third Hospital
Conditions:
Stereotactic Body Radiation Therapy
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
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.
Detailed Description
This is a prospective study. The purpose of this study is to determine whether MRD could help to evaluate whether to use drug adjuvant therapy after SBRT in patients with early lung cancer. The ctDNA ...
Eligibility Criteria
Inclusion
- Patients pathologically diagnosed as non-small cell lung cancer, and was early stage（AJCC 8th）;
- Patients aged between 18 -80 years; with expected survival time\>3 months.
- Patients with normal organ function within 30 days prior to treatment, the following criteria are met:
- 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
- Patients with small cell lung cancer (including small cell carcinoma and non-small cell carcinoma mixed lung cancer);
- Patients with factors that affect oral medication (such as cannot swallow, chronic diarrhea and intestinal obstruction, etc.) or intravenous medication;
- Patients with any other severe and/or uncontrolled disease;
- Patients with a history of psychotropic medicine abuse and cannot quit or have mental disorders;
- Patients with disease which will severely endanger their security and could not complete this study, according to the judgement of researchers；
Key Trial Info
Start Date :
June 15 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 15 2027
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT05411809
Start Date
June 15 2022
End Date
May 15 2027
Last Update
June 9 2022
Active Locations (1)
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1
Department of Radiation Oncology Cancer Center, Peking University Third Hospital 49# North Garden Rd.,Haidian Dist.
Beijing, Beijing Municipality, China, 100191