Stereotactic Radiotherapy With Different Fractionation Modes for the Early Lung Cancer

Active, not recruiting

• Conditions: Fractionation; Lung Cancer; Stereotactic Body Radiotherapy; Radiotherapy
• Interventions: Radiation: SBRT

• Registration Number: NCT05802641
• Lead Sponsor: Peking University Third Hospital

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.

Study Timeline

• Study Start: 2018-01-07
• Status Verified: 2023-03
• Study First Submitted: 2023-03-26
• Study First Submitted QC: 2023-03-26
• Last Update Submitted: 2023-03-26
• Study First Posted: 2023-04-06
• Last Update Posted: 2023-04-06
• Primary Completion: 2024-01
• Study Completion: 2025-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 100

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;

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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;

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
PFS	2025-01-01	The time from the date of treatment to the date of disease progression or death or last follow-up.

Secondary Outcome Measures

Name	Time	Method
AE	2025-03-21	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.
OS	2025-01-01	The time from the date of treatment to the date of death or last follow-up.

Trial Locations

Locations (1)

Department of radiation oncology, Peking University Third Hospital; 🇨🇳 Peking, Beijing, China