Идёт набор NCT03810651

Pencil Beam Scanning in Patients With Renal Tumors

Ранняя фаза I С лечением Renal Tumor Wilms Tumor

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 beam radiation using pencil beam scanning.
Кому может быть актуально: Состояния в реестре: Renal Tumor, Wilms Tumor. Базовые параметры: 0 лет — 30 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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Официальное название

Pilot Study of Pencil Beam Scanning Proton Beam Radiation Therapy in Patients With Renal Tumors

Обзор

This is a pilot study to assess acute toxicity in patients receiving flank irradiation using proton therapy for renal tumors.

Подробное описание

Patients with renal tumors including Wilms and clear cell sarcoma of the kidney (CCSK) are treated with multimodality therapy which may include surgery, chemotherapy, and radiation. While long-term disease control is excellent, these patients remain at risk for early and late toxicities partially from radiation. There have been no significant changes to traditional photon radiation fields, which encompass the post-operative bed, anterior abdomen, and vertebral body. Proton beam radiation using pencil beam scanning, which is characterized by Bragg peak dose deposition and high conformality of dose to target regions, is ideally suited to treat the retroperitoneum. This pilot study evaluates pencil beam scanning proton therapy (PBS-PT) to:

* result in low acute gastrointestinal toxicity in patients receiving radiation therapy for renal tumors as measured by laboratory evaluations, clinician-assessed, and patient reported health related quality of life outcomes * decrease the duration of radiation therapy * compare doses to organs at risk (OARs) using PBS-PT as compared to traditional photon fields

Вмешательства

Другое Proton beam radiation using pencil beam scanning
Proton beam radiation using pencil beam scanning, characterized by Bragg peak dose deposition and high conformality of dose to target regions

Первичные конечные точки

Occurrence of any non-hematologic toxicity that occurs within 90 days following the start of proton therapy assessed with with NCI Common toxicity criteria (CTC Version 4.0) grades]. [Срок оценки: 90 days]

Критерии участия

Критерии включения

Less than 30 years of age
Diagnosis

a. Any patient with Wilms tumor or clear cell sarcoma of the kidney who would require radiation therapy as standard of care including

Any patient with favorable histology (FH), stage III disease
Any patient with focal or diffuse anaplasia
Any patient with CCSK
The patient is a candidate for external beam radiotherapy based on standard of care for treatment of Wilms tumor or CCSK