Stereotactic Radiotherapy With Different Fractionation Modes for the Early Lung Cancer

NCT05802641 | Unknown

• 1 other identifier: DSBRT-1
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational study is to study the efficacy and safety of stereotactic body radiotherapy (SBRT) with different fractionation modes for early lung cancer. The main questions it aims to answer are: How effective are different regimens of SBRT for early lung cancer? How safe are different regimens of SBRT of SBRT for early lung cancer?

Conditions

Lung Cancer; Radiotherapy; Stereotactic Body Radiotherapy; Fractionation

Keywords

lung cancer; Stereotactic body radiotherapy; Fractionation

Outcome Measures

Primary Outcomes (1)

• PFS

  The time from the date of treatment to the date of disease progression or death or last follow-up.

  2025-01-01

Secondary Outcomes (2)

• OS

  2025-01-01

• AE

  2025-03-21

Study Arms (2)

single fraction of SBRT（30Gy/1f）

Participants with early lung cancer receive single fraction of SBRT（30Gy/1f).

Radiation: SBRT

Multiple fractions of SBRT（36Gy/3f）

Participants with early lung cancer receive multiple fractions of SBRT（36Gy/3f).

Radiation: SBRT

Interventions

SBRT RADIATION

Participants with early lung cancer receive single fraction (30Gy/1f) or multiple fractions of SBRT（36Gy/3f).

Multiple fractions of SBRT（36Gy/3f）; single fraction of SBRT（30Gy/1f）

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study intends to review the patients with early lung cancer receiving SBRT of 30Gy/1f or 36Gy/3f from 2018 to 2024 in our center.

You may qualify if:

• Signed written informed consent;
• Male or female aged ≥ 18 years and ≤ 75 years;
• patients with early lung cancer confirmed by pathology or clinical multidisciplinary team (MDT);
• The ECOG PS was 0 to 1;
• Survival time ≥3 months;
• Laboratory results during screening must meet the following requirements:
• Blood routine: neutrophil absolute count (ANC) ≥ 1.5 × 109/L, platelet count (PLT) ≥ 100 × 109/L, hemoglobin (HGB) ≥ 90 g/L (no blood transfusion or erythropoietin dependence within 7 days);
• Liver function: total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal value (ULN); Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) were less than 2.5 times ULN in subjects without liver metastasis, and ALT and AST were less than 5 times ULN in subjects with liver metastasis.
• Renal function: serum creatinine (Cr) ≤1.5 times ULN or Cr clearance ≥60 mL/min (Cockcroft-Gault formula), and urine protein (UPRO) \&lt on routine urine test; 2+ or 24 h urinary protein quantification \< 1g;
• International standardized ratio (INR) ≤1.5 times ULN and partial prothrombin time (PTT) or activated partial thrombin time (APTT) ≤1.5 times ULN during the 7 days prior to treatment;

You may not qualify if:

• any unstable systemic disease, including but not limited to active infection, congestive heart failure \[New York Heart Association (NYHA) class ≥ II\], severe arrhythmia requiring medical therapy, liver, kidney, or metabolic disease; Type I and type II respiratory failure;
• other malignancies within 5 years before randomization, except adequately treated cervical carcinoma in situ, basal cell or squamous skin cancer, local prostate cancer after radical surgery, ductal carcinoma in situ after radical surgery, or papillary thyroid cancer;

Sponsors & Collaborators

• Peking University Third Hospital: lead

Study Sites (1)

Department of radiation oncology, Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

Location

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Hongqing Zhuang, M.D.

  Department of Peking University Third Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2023
• First Posted: April 6, 2023
• Study Start: January 7, 2018
• Primary Completion: January 1, 2024
• Study Completion: January 1, 2025
• Last Updated: April 6, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: starting 6 months after publication
• Access Criteria: Only for researchers.

Locations

CN (1)