The ctDNA for Evaluating Whether to Use Adjuvant Therapy After SBRT in Patients With Early Lung Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: drug adjuvant therapy.
- Who it may be relevant to
- Registry conditions: Stereotactic Body Radiation Therapy. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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 was detected for early stage lung cancer patients before and after SBRT. If a high level of ctDNA was detected after SBRT, the patients were randomly divided into observation group and adjuvant treatment group.
Interventions
- Drug drug adjuvant therapy
The adjuvant treatment regimens depend on the judgment of oncology physicians according to pathological type, molecular characteristics and other details of the tumor.
Primary outcome measures
- PFS [Time frame: 3-year]
Secondary outcome measures (3)
- PFS [Time frame: 5-year]
- OS [Time frame: 3-year]
- OS [Time frame: 5-year]
Eligibility criteria
Inclusion criteria
- 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 criteria
- 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；
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Department of Radiation Oncology Cancer Center, Peking University Third Hospital 49# North — Beijing
Identifiers
NCT: NCT05411809 · M-SBRT