Меню
Идёт набор NCT06376669

Stereotactic Body Proton Therapy for Treatment of Primary Renal Cell Carcinoma

Фаза II С лечением Renal Cell Carcinoma

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: Proton Stereotactic Body Radiation therapy (SBRT).
Кому может быть актуально
Состояния в реестре: Renal Cell Carcinoma. 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 →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

Prospective Phase II Study of Stereotactic Body Proton Therapy for Treatment of PrimAry Renal Cell Carcinoma (SPARE)

Обзор

This study examines the impact of proton based stereotactic radiation therapy (SBRT) on kidney function as well as other oncologic outcomes including local control, locoregional and systemic failure, progression free and overall survival.

Подробное описание

The incidence of kidney cancer diagnosis has been increasing over the last years. Surgical resection represents the mainstay treatment. However, many patients are deemed unfit for surgery due to medical comorbidities or technical limitations. There are non-surgical options including active surveillance, cryotherapy, microwave ablation, radiofrequency and stereotactic radiation therapy (SBRT). SBRT using conventional x-rays has recently been shown to improve outcomes for patients with primary renal cell carcinoma (RCC) in terms of local control and toxicity. However, this treatment was associated with a significant decline in kidney function that necessitates additional intervention including dialysis in some patients. Proton therapy represents an emerging technique with unique properties that allow the bulk of the proton cancer fighting energy to be released at the tumor (Bragg peak) while sparing nearby healthy tissues and organs, particularly the remaining healthy kidney, ipsilateral kidney, bowels, spine and liver. With this technology, both kidneys, the remaining ipsilateral and contralateral, could be spared and thus less damage is expected. This study aims to study the impact of proton based SBRT on the kidney function.

Вмешательства

  • Лучевая терапия Proton Stereotactic Body Radiation therapy (SBRT)
    Radiation therapy will consist of 3-5 treatments over 1.5 - 2 weeks

Первичные конечные точки

  • Change in kidney function after PROTON-BASED SBRT treatment as assessed by serum creatine levels [Срок оценки: Baseline and every 3-6 months up to 2 years post treatment]
  • Change in kidney function after PROTON-BASED SBRT treatment as assessed by estimated glomerular rate (eGFR) values [Срок оценки: Baseline and every 3-6 months up to 2 years post treatment]
Вторичные конечные точки (5)
  • Number of PROTON-BASED SBRT treatment Adverse Events [Срок оценки: 24 months post treatment]
  • Local progression of disease after PROTON-BASED SBRT treatment as assessed by size or appearance of lesions [Срок оценки: Baseline and every 3-6 months up to 2 years post treatment]
  • Systemic progression of disease after PROTON-BASED SBRT treatment as assessed by appearance of lesions [Срок оценки: Baseline and every 3-6 months up to 2 years post treatment]
  • Time to locoregional progression [Срок оценки: Baseline and every 3-6 months up to 2 years post treatment]
  • Overall survival [Срок оценки: 24 months post treatment]

Критерии участия

Критерии включения

  • Age ≥ 18 years
  • Biopsy proven renal cell carcinoma.
  • No clinical or radiographic evidence of metastatic disease.
  • Not a candidate for surgical treatment or local ablative procedures.
  • Subjects are able to undergo either an MRI or administration of contrast agent for CT.

Критерии исключения

  • Prior history of radiation treatment with overlapping fields.
  • Patients with proven metastatic disease.
  • Female subjects who are pregnant or planning to become pregnant during the treatment.

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

США · 1 центр
  • Sibley Memorial Hospital — Washington D.C.

Публикации

  • Shaaban SG, Chen H, Singla N, Tran A, Hu C, Ke S, Jarrett TW, Deville C. Prospective phase II study of stereotactic body proton therapy for treatment of primary renal cell carcinoma (SPARE): clinical trial protocol. BMC Cancer. 2025 Jul 1;25(1):1107. doi: 10.1186/s12885-025-14486-1. PMID 40597914

Идентификаторы

NCT: NCT06376669 · J2421 · IRB00427823

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗