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

NCT ID: NCT05411809

Last Updated: 2022-06-09

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 180 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-15
• Study Completion Date: 2027-05-15

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.

Conditions

Stereotactic Body Radiation Therapy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm1

The ctDNA is positive after SBRT and no adjuvant therapy is used after SBRT.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Arm 2

The ctDNA is positive after SBRT and adjuvant therapy is used after SBRT.

Group Type: EXPERIMENTAL

drug adjuvant therapy

Intervention Type: DRUG

The adjuvant treatment regimens depend on the judgment of oncology physicians according to pathological type, molecular characteristics and other details of the tumor.

Arm 3

The ctDNA is negative after SBRT and no adjuvant therapy is used after SBRT.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DRUG

Eligibility Criteria

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；

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking University Third Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Beijing, Beijing Municipality, China

Countries

China

Central Contacts

Hongqing Zhuang

Role: CONTACT

hongqingzhuang@163.com

82264910

Yuxia Wang

Role: CONTACT

Lily31415926@126.com

82264910

Other Identifiers

M-SBRT

Identifier Type: -

Identifier Source: org_study_id