Набор скоро начнётся NCT07679607

GCC 2545- Improving Post-Radiotherapy Respiratory Function Through Sparing Serial and Parallel Components in the Lung

Фаза II С лечением Lung Cancer (NSCLC) Radiation

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: SOC Radiation Treatment Planning, INSPIRE Radiation Treatment Planning.
Кому может быть актуально: Состояния в реестре: Lung Cancer (NSCLC), Radiation. 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: США
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

Decreased respiratory function is a common side effect experienced by non-small cell lung cancer (NSCLC) patients who receive radiation therapy. In current clinical practice when treating cancerous lesions in the lung, it is not standard to explicitly try and avoid excessive radiation dose and therefore radiation injury to smaller airways. However, because of this patients may obtain damage to an airway segment can cause downstream regions in the lung to lose their "supply line" and, therefore, cause patients to lose the ability to exchange oxygen with the blood. The purpose of this clinical trial is to systematically compare post-treatment lung function of those who receive regular clinical radiation therapy (standard of care \[SoC\]) versus those who receive the airway-sparing radiation therapy regimen. The investigators hope to show that, by preserving airways and connected lung regions, participants will be able to retain a larger amount of their lung function, which will have a direct, positive impact on their post-treatment quality of life.

Вмешательства

Лучевая терапия SOC Radiation Treatment Planning
Two treatment plans will be created for each patient - an SOC RT plan and an INSPIRE RT plan. Both plans will fulfill clinical dosimetric objectives for tumor target and OARs, and will need to be reviewed and approved by the Radiation Oncologist. The trial will allow intensity modulated radiotherapy (IMRT) or volumetric modulated arc therapy (VMAT). Both techniques have been validated for INSPIRE RT previously. Both plans meet clinical dosimetric objectives. The INSPIRE plan achieves the additio
Лучевая терапия INSPIRE Radiation Treatment Planning
Two treatment plans will be created for each patient - an SOC RT plan and an INSPIRE RT plan. Both plans will fulfill clinical dosimetric objectives for tumor target and OARs, and will need to be reviewed and approved by the Radiation Oncologist. The trial will allow intensity modulated radiotherapy (IMRT) or volumetric modulated arc therapy (VMAT). Both techniques have been validated for INSPIRE RT previously. Both plans meet clinical dosimetric objectives. The INSPIRE plan achieves the additio

Первичные конечные точки

Measurement of Post-Radiation retention of ventilation at 12 months through imaging. [Срок оценки: 12 months]

Вторичные конечные точки (1)

Number of patients with Grade 2 or higher toxicities defined by Common Terminology Criteria for Adverse Events (CTCAE) v5 [Срок оценки: 12 months]

Критерии участия

Критерии включения

Step 1- Inclusion Criteria

Adult (≥18 years) patients (both sexes) with histologically diagnosed Stage III NSCLC per AJCC ver 9
Patients to be treated with definitive external beam photon radiotherapy with or without systemic therapy (e.g., chemothrapy, immunotherapy).
No restrictions on number radiotherapy fractions, or location/number of lesions
ECOG performance status ≤ 3
Ability to hold breath for ≥ 15 seconds
Patient has signed informed consent document and agreed to study procedures

Step 2- Inclusion Criteria 1. Patient has completed 4DCT and BHCT with subsequent plans created and Radiation Oncologist has determined that patient would benefit from INSPIRE RT.

Критерии исключения

Step 1- Exclusion Criteria

Prior lung cancer-directed radiotherapy
Recent (< 12 mo) or planned lung surgery (which would confound pre- and post-RT lung function measures)
Patients with metal implants or metal stents in the thoracic region
Known severe chronic obstructive pulmonary disease or interstitial lung disease
Women who are pregnant or trying to get pregnant

Step 2- Exclusion Criteria

1\. Patient found to not benefit from INSPIRE RT after comparison of treatment plans.

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

Здоровые добровольцы: Нет