The ctDNA for Evaluating Whether to Use Adjuvant Therapy After SBRT in Patients With Early Lung Cancer

Not Applicable

Not yet recruiting

• Conditions: Stereotactic Body Radiation Therapy
• Interventions: Drug: drug adjuvant therapy

• Registration Number: NCT05411809
• Lead Sponsor: Peking University Third Hospital

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 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.

Study Timeline

• Status Verified: 2022-05
• Study First Submitted: 2022-05-25
• Study First Submitted QC: 2022-06-06
• Last Update Submitted: 2022-06-06
• Study First Posted: 2022-06-09
• Last Update Posted: 2022-06-09
• Study Start: 2022-06-15
• Primary Completion: 2024-06-15
• Study Completion: 2027-05-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 180

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；

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 2	drug adjuvant therapy	The ctDNA is positive after SBRT and adjuvant therapy is used after SBRT.

Primary Outcome Measures

Name	Time	Method
PFS	3-year	progression-free survival

Secondary Outcome Measures

Name	Time	Method
PFS	5-year	progression-free survival
OS	5-year	overall survival

Trial Locations

Locations (1)

Department of Radiation Oncology Cancer Center, Peking University Third Hospital 49# North Garden Rd.,Haidian Dist.; 🇨🇳 Beijing, Beijing, China