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

Stereotactic Body Radiotherapy Clinical Trial

— USBRT-1  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05802654
• Other study ID #: USBRT-1
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2023
• Est. completion date: June 2028

Study information

• Verified date: June 2023
• Source: Peking University Third Hospital
• Contact: Hongqing Zhuang, M.D.
• Phone: +861082264910
• Email: hongqingzhuang[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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?

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: June 2028
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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;

Related Conditions & MeSH terms

• Early Lung Cancer
• Lung Neoplasms
• Stereotactic Body Radiotherapy

Intervention

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

Locations

Country	Name	City	State
China	Department of radiation oncology, Peking University Third Hospital	Peking	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University Third Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PFS	The time from the date of treatment to the date of disease progression or death or last follow-up.	3 years
Secondary	OS	The time from the date of treatment to the date of death or last follow-up.	3 years
Secondary	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