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

NCT05411809 | Not Yet Recruiting DMC

• 1 other identifier: M-SBRT
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

Stereotactic Body Radiation Therapy

Outcome Measures

Primary Outcomes (1)

• PFS

  progression-free survival

  3-year

Secondary Outcomes (3)

• PFS

  5-year

• OS

  3-year

• OS

  5-year

Study Arms (3)

Arm1

NO INTERVENTION

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

Arm 2

EXPERIMENTAL

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

Drug: drug adjuvant therapy

Arm 3

NO INTERVENTION

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

Interventions

drug adjuvant therapy 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 2

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients pathologically diagnosed as non-small cell lung cancer, and was early stage（AJCC 8th）;
• Patients aged between 18 -80 years; with expected survival time\>3 months.
• Patients with normal organ function within 30 days prior to treatment, the following criteria are met:
• 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;

You may not qualify if:

• Patients with small cell lung cancer (including small cell carcinoma and non-small cell carcinoma mixed lung cancer);
• Patients with factors that affect oral medication (such as cannot swallow, chronic diarrhea and intestinal obstruction, etc.) or intravenous medication;
• Patients with any other severe and/or uncontrolled disease;
• Patients with a history of psychotropic medicine abuse and cannot quit or have mental disorders;
• Patients with disease which will severely endanger their security and could not complete this study, according to the judgement of researchers；

Sponsors & Collaborators

• Peking University Third Hospital: lead

Study Sites (1)

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

Beijing, Beijing Municipality, 100191, China

Location

MeSH Terms

Interventions

Chemotherapy, Adjuvant

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Drug Therapy

Central Study Contacts

Hongqing Zhuang

CONTACT

82264910; hongqingzhuang@163.com

Yuxia Wang

CONTACT

82264910; Lily31415926@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 25, 2022
• First Posted: June 9, 2022
• Study Start: June 15, 2022
• Primary Completion: June 15, 2024
• Study Completion (Estimated): May 15, 2027
• Last Updated: June 9, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)