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

• Sponsor: Peking University Third Hospital (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05411809
• Collaborator: (none)
• Enrollment: 180
• Location: 1
• Arms: 3
• Anticipated Duration (Months): 59
• Patients Per Site Per Month: 3.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Stereotactic Body Radiation Therapy	Drug: drug adjuvant therapy	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 180 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: The ctDNA for Evaluating Whether to Use Adjuvant Therapy After SBRT in Patients With Early Lung Cancer
• Anticipated Study Start Date: Jun 15, 2022
• Anticipated Primary Completion Date: Jun 15, 2024
• Anticipated Study Completion Date: May 15, 2027

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. PFS [3-year]

   progression-free survival

Secondary Outcome Measures

1. PFS [5-year]

   progression-free survival

2. OS [3-year]

   overall survival

3. OS [5-year]

   overall survival

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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:

4. 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；

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Radiation Oncology Cancer Center, Peking University Third Hospital 49# North Garden Rd.,Haidian Dist.	Beijing	Beijing	China	100191

Sponsors and Collaborators

• Peking University Third Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Peking University Third Hospital
• ClinicalTrials.gov Identifier: NCT05411809
• Other Study ID Numbers: M-SBRT
• First Posted: Jun 9, 2022
• Last Update Posted: Jun 9, 2022
• Last Verified: May 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Jun 9, 2022