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Идёт набор NCT04676828

Functional Lung Avoidance SPECT-guided Radiation Therapy of Lung Cancer

Без фазы С лечением Lung Cancer Radiation-Induced Disorder Radiation Pneumonitis Pulmonary Disease

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: Single-photon-emission CT scan.
Кому может быть актуально
Состояния в реестре: Lung Cancer, Radiation-Induced Disorder, Radiation Pneumonitis, Pulmonary Disease. 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
Австралия, Дания
Следующий шаг
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Официальное название

Functional Lung Avoidance SPECT-guided (ASPECT) Radiation Therapy for Lung Cancer Patients: Phase II Randomised Clinical Trial

Обзор

Study aims to determine if functional lung avoidance based on perfusion single photon emission (SPECT)/CT scan, improves toxicity outcomes for patients with advanced lung cancer undergoing chemo-radiotherapy. Functional avoidance implies a dose plan that takes functional distribution in the lung into account, and avoids highly functional lung volumes sparing them from radiation.

Подробное описание

In this project, a novel method of safe radiotherapy delivery shall be tested for patients with lung cancer in a clinical setting. Functional avoidance radiotherapy is a new method that protect highly functional lung tissue from radiation, while delivering high dose radiotherapy to the lung tumour. Radiotherapy is usually based on a CT scan that does not account for functional variations in the lungs. Therefore, I hypothesize that using functional distribution in the lungs and avoiding irradiation of highly functional lung will improve treatment outcome for individual patients with lung cancer.

The objective of my project is to determine if functional image guided radiotherapy (functional avoidance radiotherapy) improves toxicity outcomes for patients with lung cancer undergoing curative chemo-radiotherapy in a prospective clinical trial.

To reach this objective, the impact of functional avoidance radiotherapy on pulmonary toxicity measured by the incidence and severity of radiation-induced lung disease shall be assessed. Additionally, loco-regional control, time to progression, overall survival, quality of life and radiation-induced molecular response in patients treated with functional avoidance radiotherapy shall be assessed and compared to patients receiving standard treatment.

Вмешательства

  • Диагностический тест Single-photon-emission CT scan
    SPECT/CT scan is an established functional modality used in the diagnosis and monitoring of lung disease. SPECT/CT scan images pulmonary circulation, where perfused areas equate with normal functional lung

Первичные конечные точки

  • Radiation-induced lung toxicity [Срок оценки: Measured serially from 1 to 12 months after treatment completion]
Вторичные конечные точки (5)
  • Quality of life [Срок оценки: Measured serially from 1 to 12 months after treatment completion]
  • Patient reported lung symptoms [Срок оценки: Measured serially from 1 to 12 months after treatment completion]
  • Progression-free survival [Срок оценки: at 12 months]
  • Overall survival [Срок оценки: at 12 months]
  • Loco-regional control rate [Срок оценки: at 12 months]

Критерии участия

Критерии включения

  • histologically verified lung cancer (small-cell and non-small cell lung cancer)
  • referred for radiotherapy with curative intent
  • radiation dose of 60-66 Gy given in 2-Gy fractions, other dose levels and fractionation schedules accepted, as per site standard
  • concurrent chemotherapy is accepted
  • patients with oligometastatic disease are allowed, where metastasis have been ablated with surgery or radiotherapy
  • receiving (chemo)-radiotherapy to the thoracic disease with curative intent
  • adults over 18, that have given oral and written informed consent before patient registration.

Критерии исключения

  • concurrent immunotherapy
  • previous radiotherapy to the thorax
  • other uncontrolled malignancies; any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Тройное слепое
Основная цель
Лечение

Центры проведения

Австралия · 1 центр
  • Sydney West Radiation Oncology Network Westmead and Blacktown Hospitals — Sydney
Дания · 1 центр
  • Department of Oncology, Aarhus University Hospital — Aarhus

Публикации

  • Khalil AA, Hau E, Gebski V, Grau C, Gee H, Nyeng TB, West K, Kramer S, Farlow D, Knap M, Moller DS, Hoffmann L, Farr KP. Personal innovative approach in radiation therapy of lung cancer- functional lung avoidance SPECT-guided (ASPECT) radiation therapy: a study protocol for phase II randomised double-blind clinical trial. BMC Cancer. 2021 Aug 21;21(1):940. doi: 10.1186/s12885-021-08663-1. PMID 34418994

Идентификаторы

NCT: NCT04676828 · KFE-1930

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗