Clinical trial · Interventional
The ctDNA for Evaluating Whether to Use Adjuvant Therapy After SBRT in Patients With Early Lung Cancer
NCT05411809CI-TRIAL-00058999not yet recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Stereotactic Body Radiation Therapy | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| drug adjuvant therapy | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- NO_INTERVENTION
- label
- Arm1
- description
- The ctDNA is positive after SBRT and no adjuvant therapy is used after SBRT.
- type
- EXPERIMENTAL
- label
- Arm 2
- description
- The ctDNA is positive after SBRT and adjuvant therapy is used after SBRT.
- interventionNames
- Drug: drug adjuvant therapy
- type
- NO_INTERVENTION
- label
- Arm 3
- description
- The ctDNA is negative after SBRT and no adjuvant therapy is used after SBRT.
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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;
References
Publications (0)
Data not yet available
No reference posted for this study.