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

Primary Purpose

Early Lung Cancer, Stereotactic Body Radiotherapy

Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
SBRT
Sponsored by
Peking University Third Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Early Lung Cancer focused on measuring lung cancer, Stereotactic body radiotherapy (SBRT), High dose, Fraction

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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;

Sites / Locations

  • Department of radiation oncology, Peking University Third Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Participants receiving SBRT

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
March 26, 2023
Last Updated
June 20, 2023
Sponsor
Peking University Third Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05802654
Brief Title
Single Ultra-high Dose Stereotactic Body Radiation Therapy for Early Lung Cancer
Acronym
USBRT-1
Official Title
Clinical Study of Single Ultra-high Dose Stereotactic Body Radiation Therapy for Early Lung Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 2023 (Anticipated)
Primary Completion Date
June 2025 (Anticipated)
Study Completion Date
June 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Peking University Third Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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?
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Early Lung Cancer, Stereotactic Body Radiotherapy
Keywords
lung cancer, Stereotactic body radiotherapy (SBRT), High dose, Fraction

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
single fraction of ultra-high dose SBRT
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Participants receiving SBRT
Arm Type
Experimental
Arm Description
The participants enrolled will receive single fraction of ultra-high dose SBRT(30Gy/1F).
Intervention Type
Radiation
Intervention Name(s)
SBRT
Intervention Description
The participants enrolled will receive single fraction of ultra-high dose SBRT(30Gy/1F).
Primary Outcome Measure Information:
Title
PFS
Description
The time from the date of treatment to the date of disease progression or death or last follow-up.
Time Frame
3 years
Secondary Outcome Measure Information:
Title
OS
Description
The time from the date of treatment to the date of death or last follow-up.
Time Frame
3 years
Title
AE
Description
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.
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hongqing Zhuang, M.D.
Phone
+861082264910
Email
hongqingzhuang@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yi Chen, M.D.
Phone
13240774157
Email
yichen@bjmu.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hongqing Zhuang, M.D.
Organizational Affiliation
Department of Peking University Third Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Department of radiation oncology, Peking University Third Hospital
City
Peking
State/Province
Beijing
ZIP/Postal Code
100191
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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

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

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