Single Ultra-high Dose Stereotactic Body Radiation Therapy for Early Lung Cancer

NCT05802654 | Not Yet Recruiting DMC

• 1 other identifier: USBRT-1
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this prospective single-arm phase II study is to study the efficacy and safety of stereotactic body radiotherapy (SBRT) for early lung cancer. The main questions it aims to answer are: How effective is this regimen of SBRT for early lung cancer? How safe is this regimen of SBRT for early lung cancer?

Conditions

Early Lung Cancer; Stereotactic Body Radiotherapy

Keywords

lung cancer; Stereotactic body radiotherapy (SBRT); High dose; Fraction

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.

  3 years

Secondary Outcomes (2)

• OS

  3 years

• AE

  3 years

Study Arms (1)

Participants receiving SBRT

EXPERIMENTAL

The participants enrolled will receive single fraction of ultra-high dose SBRT(30Gy/1F).

Radiation: SBRT

Interventions

SBRT RADIATION

The participants enrolled will receive single fraction of ultra-high dose SBRT(30Gy/1F).

Participants receiving SBRT

Eligibility Criteria

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

You may qualify if:

• Signed written informed consent;
• Male or female aged ≥ 18 years and ≤ 75 years;
• patients with early stage lung cancer confirmed by pathology or clinical MDT;
• The physical state score (ECOG PS) of the eastern tumor cooperative group was 0 \~ 1;
• Expected 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;
• For female subjects of reproductive age, urine or serum pregnancy tests should be negative within 3 days prior to receiving the first fraction of SBRT. If the urine pregnancy test results cannot be confirmed negative, a blood pregnancy test is requested;
• Compliance with the research protocol is expected to be good.

You may not qualify if:

• currently participating in an interventional clinical trial;
• 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;
• women who are pregnant or breastfeeding or who plan to become pregnant or breastfeeding during the study period;

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

  STUDY CHAIR

Central Study Contacts

Hongqing Zhuang, M.D.

CONTACT

+861082264910; hongqingzhuang@163.com

Yi Chen, M.D.

CONTACT

13240774157; yichen@bjmu.edu.cn

Study Design

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

Model Details: single fraction of ultra-high dose SBRT

Study Record Dates

• First Submitted: March 26, 2023
• First Posted: April 6, 2023
• Study Start: June 1, 2023
• Primary Completion: June 1, 2025
• Study Completion (Estimated): June 1, 2028
• Last Updated: June 22, 2023

Record last verified: 2023-06

Data Sharing

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

Locations

CN (1)