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

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05411809
• Other study ID #: M-SBRT
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 15, 2022
• Est. completion date: May 15, 2027

Study information

• Verified date: May 2022
• Source: Peking University Third Hospital
• Contact: Hongqing Zhuang
• Phone: 82264910
• Email: hongqingzhuang[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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;

Related Conditions & MeSH terms

• Stereotactic Body Radiation Therapy

Intervention

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.

Locations

Country	Name	City	State
China	Department of Radiation Oncology Cancer Center, Peking University Third Hospital 49# North Garden Rd.,Haidian Dist.	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University Third Hospital

Country where clinical trial is conducted

China, 

Outcome

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