Идёт набор NCT05758688

PROton Therapy for Post Surgical Treatment of GYNecologic Cancer

Фаза II С лечением Cervical Cancer Uterine Cancer Endometrial 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: Whole Pelvis (WP) Pencil Beam Scanning Proton Radiation (PBS PRT).
Кому может быть актуально: Состояния в реестре: Cervical Cancer, Uterine Cancer, Endometrial Cancer. Базовые параметры: от 18 лет · Женщины.
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

Adjuvant Proton Whole Pelvis Radiation Therapy for Treatment of Post-Surgical Gynecologic Cancers

Обзор

This is a single institution, multi-center, Phase II, single-arm study, using Whole Pelvis (WP) Pencil Beam Scanning Proton Radiation (PBS PRT) in the post-surgical, adjuvant setting for definitive treatment of gynecologic cancers. The purpose of this study is to estimate rate of acute clinician-reported gastrointestinal (GI) toxicity using WP PBS PRT in the definitive treatment of gynecologic cancers in the post-surgical, adjuvant setting.

Подробное описание

This is a single institution, multi-site study, and thus will include patients from geographic locations with Penn proton centers in the Philadelphia, Lancaster and South New Jersey area. The study will be conducted at the University of Pennsylvania Department of Radiation Oncology and associated Clinical facilities.

The study intervention is Whole Pelvis (WP) Pencil Beam Scanning Proton Radiation (PBS PRT) as part of the definitive treatment of gynecologic cancers in the post-hysterectomy, adjuvant setting. Patients will be treated with doses of 45 or 50.4 Gy in 1.8 Gy daily fractions.

Вмешательства

Лучевая терапия Whole Pelvis (WP) Pencil Beam Scanning Proton Radiation (PBS PRT)
The study intervention is Whole Pelvis (WP) Pencil Beam Scanning Proton Radiation (PBS PRT) as part of the definitive treatment of gynecologic cancers in the post-hysterectomy, adjuvant setting. Patients will be treated with doses of 45 or 50.4 Gy in 1.8 Gy daily fractions. The volume treated will include the whole pelvis according to Radiation Therapy Oncology Group post-hysterectomy pelvis guidelines.

Первичные конечные точки

Acute clinician-reported gastrointestinal (GI) toxicity. [Срок оценки: Up to 6 months after end of treatment at follow up visits]

Вторичные конечные точки (3)

Acute clinician-reported genitourinary (GU) toxicity. [Срок оценки: Up to 6 months after end of treatment at follow up visits]
Acute patient-reported gastrointestinal (GI) and genitourinary (GU) toxicity and quality of life. [Срок оценки: Up to 6 months after end of treatment at follow up visits]
Loco-regional recurrence free survival, disease free survival, and overall survival. [Срок оценки: Up to 2 years]

Критерии участия

Критерии включения

Histologically confirmed cervical or endometrial cancer
Indication for adjuvant whole pelvic radiation therapy, with or without systemic therapy
Age of 18 years or older
Written informed consent
ECOG of 0-2 within 3 months of enrolling