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

Официальное название

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

Обзор

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?

Подробное описание

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).

Вмешательства

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

Первичные конечные точки

• PFS [Срок оценки: 3 years]

Вторичные конечные точки (2)

• OS [Срок оценки: 3 years]
• AE [Срок оценки: 3 years]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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;

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Department of radiation oncology, Peking University Third Hospital — Пекин

Идентификаторы

NCT: NCT05802654 · USBRT-1

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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