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Идёт набор NCT07412327

Prospective Phase II Clinical Study of Stereotactic Body Proton Therapy (SBPT) for Lung Cancer

Без фазы С лечением Early-Stage Lung Cancer Lung Cancer

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Stereotactic Body Proton Therapy.
Кому может быть актуально
Состояния в реестре: Early-Stage Lung Cancer, Lung Cancer. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Китай
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

A Single-Center, Prospective Phase II Clinical Study of Stereotactic Body Proton Therapy (SBPT) for Early-Stage Non-Small Cell Lung Cancer

Обзор

This study included patients with early-stage lung cancer cT1-3N0M0, stage IA-IIB (American Joint Committee on Cancer eighth edition staging, AJCC 8th ) who were inoperable or refused surgery. They were divided into peripheral type and central type according to the tumor location and received radical Stereotactic Body Proton Therapy (SBPT) for Early-Stage Non-Small Cell Lung Cancer. The prescribed dose for patients with peripheral lung cancer is 48-60Gray(Gy) (Relative Biological Effectiveness, RBE)/4-6 fractions, and for patients with central lung cancer, the prescribed dose is 50-70Gy(RBE)/10-15 fractions. After treatment, follow-up visits will be conducted to observe short-term and long-term efficacy, adverse reactions and patient quality of life.

Вмешательства

  • Лучевая терапия Stereotactic Body Proton Therapy
    They were divided into peripheral type and central type according to the tumor location and received radical SBPT for Early-Stage Non-Small Cell Lung Cancer. . The prescribed dose for patients with peripheral lung cancer is 48-60Gy(RBE)/4-6 fractions, and for patients with central lung cancer, the prescribed dose is 50-70Gy(RBE)/10-15 fractions.

Первичные конечные точки

  • Progression-free Survival [Срок оценки: Up to 3 years]
Вторичные конечные точки (5)
  • Overall Survival [Срок оценки: UP to 3 years]
  • Local Control Rate [Срок оценки: Up to 3 years]
  • Quality of life scores [Срок оценки: Up to 3 years]
  • Quality of life scores [Срок оценки: Up to 3 years]
  • Rate of grade 3-5 adverse events [Срок оценки: Up to 3 years]

Критерии участия

Критерии включения

  • .Lung cancer confirmed by histology and/or cytology; and in the absence of pathological diagnosis, patients who meet the following conditions can also be included: diagnosed by more than 2 imaging modalities, and the clinical diagnosis of lung cancer is confirmed after multidisciplinary team (MDT) discussion.
  • The clinical staging based on positron emission tomography(PET)-computer tomography(CT) examination is: cT1\~3 N0M0, stage IA-IIB (AJCC eighth edition).
  • Age: 18 years and above.
  • Karnofsky(KPS) score ≥60.
  • The doctor assesses that surgical treatment is not suitable or the patient refuses surgery.
  • Relatively good organ function:
  • Normal bone marrow function: white blood cell (WBC)≥3×109/L, Platelet ≥80×109/L, Hemoglobin(HGB)≥90g/L
  • Normal liver and kidney function:
  • Total bilirubin, Aspartate Aminotransferase(AST), and ALT(Alanine Aminotransferase)≤2.0×upper limit of normal values;
  • Creatinine clearance ≥60ml/min or creatinine ≤1.5×upper limit of normal value
  • The patient has signed an informed consent form and is willing and able to comply with planned study visits, treatment plans, laboratory tests, and other study procedures.

Критерии исключения

  • Patients with other malignant tumors.
  • Poorly controlled heart failure, respiratory failure, heart function, and lung function below grade 3 (including grade 3).
  • Those whose laboratory test values do not meet relevant standards before enrollment.
  • Patients who cannot cooperate with regular follow-up due to psychological, social, family and geographical reasons.
  • Women of childbearing age who have a positive pregnancy test and women who are breastfeeding.
  • Patients considered inappropriate for inclusion by other investigators.

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
  • Guangzhou Concord Cancer Center — Гуанчжоу

Идентификаторы

NCT: NCT07412327 · 2025-IIT-002

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗