Stereotactic Radiotherapy With Different Fractionation Modes for the Early Lung Cancer

Lung Cancer Clinical Trial

— DSBRT-1  

Official title:

Clinical Study of Stereotactic Radiotherapy With Different Fractionation Modes for Early Lung Cancer

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05802641
• Other study ID #: DSBRT-1
• Status: Active, not recruiting
• Start date: January 7, 2018
• Est. completion date: January 2025

Study information

• Verified date: March 2023
• Source: Peking University Third Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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?

Description:

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.. 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: January 2025
• Est. primary completion date: January 2024
• 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 lung cancer confirmed by pathology or clinical multidisciplinary team (MDT);

4. The ECOG PS was 0 to 1;

5. 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;

Exclusion Criteria:

1. 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;

2. 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;

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms
• Radiotherapy
• Stereotactic Body Radiotherapy

Intervention

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

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.	2025-01-01
Secondary	OS	The time from the date of treatment to the date of death or last follow-up.	2025-01-01
Secondary	AE	The incidence of All adverse event (AE), treatment emergent AE (TEAE), treatment-related AE (TRAE), serious AE (SAE) and radiation-related AE(rAE), the relevance and severity related with the study protocol.	2025-03-21