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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Stereotactic Body Radiation Therapy
• Intervention / Treatment: Drug: drug adjuvant therapy

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 Type: Interventional
• Enrollment (Anticipated): 180
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hongqing zhuang; Phone Number: 82264910; Email: hongqingzhuang@163.com
• Study Contact Backup: Name: Yuxia Wang; Phone Number: 82264910; Email: Lily31415926@126.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100191
      • Department of Radiation Oncology Cancer Center, Peking University Third Hospital 49# North Garden Rd.,Haidian Dist.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Arm1; The ctDNA is positive after SBRT and no adjuvant therapy is used after SBRT.
Experimental: Arm 2; The ctDNA is positive after SBRT and adjuvant therapy is used after SBRT.	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.
No Intervention: Arm 3; The ctDNA is negative after SBRT and no adjuvant therapy is used after SBRT.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PFS	progression-free survival	3-year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PFS	progression-free survival	5-year
OS	overall survival	3-year
OS	overall survival	5-year

Collaborators and Investigators

• Sponsor: Peking University Third Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): June 15, 2022
• Primary Completion (Anticipated): June 15, 2024
• Study Completion (Anticipated): May 15, 2027

Study Registration Dates

• First Submitted: May 25, 2022
• First Submitted That Met QC Criteria: June 6, 2022
• First Posted (Actual): June 9, 2022

Study Record Updates

• Last Update Posted (Actual): June 9, 2022
• Last Update Submitted That Met QC Criteria: June 6, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: M-SBRT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No