Stereotactic Radiotherapy With Different Fractionation Modes for the Early Lung Cancer

NCT ID: NCT05802641

Last Updated: 2023-04-06

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-01-07
• Study Completion Date: 2025-01-31

Brief 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?

Detailed 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.

Conditions

Lung Cancer; Radiotherapy; Stereotactic Body Radiotherapy; Fractionation

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: OTHER

Study Groups

single fraction of SBRT（30Gy/1f）

Participants with early lung cancer receive single fraction of SBRT（30Gy/1f).

SBRT

Intervention Type: RADIATION

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

Multiple fractions of SBRT（36Gy/3f）

Participants with early lung cancer receive multiple fractions of SBRT（36Gy/3f).

SBRT

Intervention Type: RADIATION

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

Interventions

SBRT

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

Intervention Type: RADIATION

Eligibility Criteria

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) &lt 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;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking University Third Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hongqing Zhuang, M.D.

Role: PRINCIPAL_INVESTIGATOR

Department of Peking University Third Hospital

Locations

Department of radiation oncology, Peking University Third Hospital

Beijing, Beijing Municipality, China

Countries

China

Other Identifiers

DSBRT-1

Identifier Type: -

Identifier Source: org_study_id