Single Ultra-high Dose Stereotactic Body Radiation Therapy for Early Lung Cancer (USBRT-1)

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

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?

Study Overview

• Status: Not yet recruiting
• Conditions: Stereotactic Body Radiotherapy; Early Lung Cancer
• Intervention / Treatment: Radiation: SBRT

Detailed Description

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. This study intends to enroll 100 participants in 2 years. The participants enrolled will receive single fraction of ultra-high dose stereotactic body radiotherapy (SBRT) (30Gy/1F).

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hongqing Zhuang, M.D.; Phone Number: +861082264910; Email: hongqingzhuang@163.com
• Study Contact Backup: Name: Yi Chen, M.D.; Phone Number: 13240774157; Email: yichen@bjmu.edu.cn

Study Locations

• China
  • Beijing
    • Peking, Beijing, China, 100191
      • Department of Radiation Oncology, Peking University Third Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Signed written informed consent;
2. Male or female aged ≥ 18 years and ≤ 75 years;
3. patients with early stage lung cancer confirmed by pathology or clinical MDT;
4. The physical state score (ECOG PS) of the eastern tumor cooperative group was 0 ~ 1;
5. Expected survival time ≥3 months;

6. Laboratory results during screening must meet the following requirements:

   1. 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);
   2. 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.
   3. Renal function: serum creatinine (Cr) ≤1.5 times ULN or Cr clearance ≥60 mL/min (Cockcroft-Gault formula), and urine protein (UPRO) < on routine urine test; 2+ or 24 h urinary protein quantification < 1g;
   4. 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;
7. 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;
8. Compliance with the research protocol is expected to be good.

Exclusion Criteria:

1. currently participating in an interventional clinical trial;
2. 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;
3. 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;
4. women who are pregnant or breastfeeding or who plan to become pregnant or breastfeeding during the study period;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Participants receiving SBRT; The participants enrolled will receive single fraction of ultra-high dose SBRT(30Gy/1F).	Radiation: SBRT; The participants enrolled will receive single fraction of ultra-high dose SBRT(30Gy/1F).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PFS	The time from the date of treatment to the date of disease progression or death or last follow-up.	3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
OS	The time from the date of treatment to the date of death or last follow-up.	3 years
AE	The incidence of All adverse event (AE), treatment emergent AE (TEAE), treatment-related AE (TRAE), immune-related AE (irAE), serious AE (SAE) and radiation-related AE(rAE), the relevance and severity related with the study protocol.	3 years

Collaborators and Investigators

• Sponsor: Peking University Third Hospital
• Investigators: Study Chair: Hongqing Zhuang, M.D., Department of Peking University Third Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2023
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): June 1, 2028

Study Registration Dates

• First Submitted: March 26, 2023
• First Submitted That Met QC Criteria: March 26, 2023
• First Posted (Actual): April 6, 2023

Study Record Updates

• Last Update Posted (Actual): June 22, 2023
• Last Update Submitted That Met QC Criteria: June 20, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: lung cancer; Fraction; Stereotactic body radiotherapy (SBRT); High dose
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: USBRT-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Study Protocol, Statistical Analysis Plan, and Clinical Study Report will be shared with researchers for research use after permission was obtained from the study institution.
• IPD Sharing Time Frame: starting 6 months after publication
• IPD Sharing Access Criteria: Researchers
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No