Идёт набор NCT06644846

Spatially Fractionated Radiation Treatment for Gynaecological Cancers

Без фазы С лечением Cervical Cancer Gynecologic Cancer Recurrent 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: Spatially fractionated radiation therapy.
Кому может быть актуально: Состояния в реестре: Cervical Cancer, Gynecologic Cancer, Recurrent Cancer. Базовые параметры: 18 лет — 70 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: Индия
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

A Prospective Study of Spatially Fractionated Radiation Treatment Using Rapid Rod Technique for Gynaecological Cancers

Обзор

This is a prospective study to evaluate in-field disease control, survival and late toxicity in patients with cervical cancer or pelvic recurrence treated with spatially fractionated RT. The study will include patients with primary cervical cancer or pelvic recurrence not suitable for brachytherapy in view of anticipated or actual suboptimal target coverage due to aberrant anatomy or large residual disease at the time of brachytherapy.

Подробное описание

Patients will be treated with spatially fractionated radiation therapy (SFRT) after EBRT completion to a dose of 25-30 Gy in 5-6 fractions in the primary setting. For patients receiving re-irradiation, 20-25 Gy in 4-5 fractions will be delivered with SFRT, which however may be individualised to match with clinical practice in the re-RT setting. Total EQD2 Gy for organs at risk will be matched to brachytherapy.

The study will be conducted at Tata Memorial Hospital, Mumbai and Advanced Centre for Treatment, Research and Education In Cancer (ACTREC), Navi Mumbai.

Вмешательства

Лучевая терапия Spatially fractionated radiation therapy
Spatially fractionated" radiation therapy (SFRT) enables delivery of high-dose radiation to discrete sub-volumes inside a tumour target while restricting the remainder of the target to a safer lower dose. This technique results in generation of intentionally heterogeneous dose distribution with spatial areas of "hot" and "cold" spots within the tumour, thereby sparing nearby organs at risk.

Первичные конечные точки

In-field control [Срок оценки: 1-year]

Вторичные конечные точки (5)

Progression-free and overall survival [Срок оценки: 2-years]
Late grade 2 or higher genitourinary and gastrointestinal toxicities. [Срок оценки: > 90 days]
To compare SFRT in-silico dose volume parameters with proton beam plans [Срок оценки: 1-year]
To obtain biopsy tissue for translational research before and after SFRT [Срок оценки: 1-year]
To study overall response in reference to PET FDG and Hypoxia imaging at baseline and before SFRT [Срок оценки: 1-year]

Критерии участия

Критерии включения

Patients with cervical cancer post EBRT, with expected suboptimal brachytherapy dose coverage due to-

Aberrant uterine or pelvic anatomy leading to difficulty in localization of the cervical OS or negotiation of the uterine canal accurately by two independent clinicians in up to two procedures.
Large residual disease at the time of brachytherapy with anticipated suboptimal target coverage either determined in clinic based on pre-brachytherapy imaging or at dose planning (e.g. figure 2).
Very narrow vaginal canal not accommodating even the smallest intracavitary or vaginal cylinder applicators.
Patients with inoperable endometrial cancer not suitable for anaesthesia or have anticipated suboptimal coverage of target volume at brachytherapy as identified on pre-brachytherapy imaging obtained after EBRT.
Patients with large pelvic recurrences after surgery and/or (chemo) radiation, not amenable to surgical salvage or brachytherapy after salvage EBRT due to reasons specified in item 1.
Patients with contraindications to anaesthesia for brachytherapy with sufficient risk of on-table or post procedure adverse events.