Идёт набор NCT05640999

Adjuvant Therapy in POLE-Mutated and p53-Wildtype/NSMP Early Stage Endometrial Cancer RAINBO BLUE & TAPER

Фаза II С лечением 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: Vaginal brachytherapy, Adjuvant radiotherapy (EBRT +/- brachytherapy), Observation.
Кому может быть актуально: Состояния в реестре: 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, Австралия, Канада, Франция, Италия +3
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 Phase II Study of Tailored Adjuvant Therapy in POLE-Mutated and p53-Wildtype/NSMP Early Stage Endormetrial Cancer (RAINBO BLUE & TAPER)

Обзор

This protocol tests de-escalated adjuvant treatment in patients with POLE-mutated or p53wt/NSMP (p53 wildtype/no specific molecular profile) early-stage endometrial cancer (EC). Patients may be enrolled in one of two sub-studies * EN10.A/RAINBO BLUE: POLE-mutated EC * EN10.B/TAPER: p53 wildtype / NSMP EC

Подробное описание

This study is being done in order to find out if this new approach is better or worse than the usual approach for early-stage endometrial cancer. The usual approach is defined as the care most people get for early-stage endometrial cancer.

The usual approach for patients who are not in a study is treatment with surgery. Tissue that is removed as part of this procedure is analyzed in the pathology laboratory to guide the doctor to decide whether or not additional treatment such as radiation and or chemotherapy should be recommended.

Вмешательства

Лучевая терапия Vaginal brachytherapy
Vaginal brachytherapy should be delivered using a vaginal cylinder, or alternatively ovoids
Лучевая терапия Adjuvant radiotherapy (EBRT +/- brachytherapy)
Treatment is to be delivered using 4-18 MV photons. MV, kV or CBCT imaging capabilities are required. Planning systems with capability for DICOM data transfer must be used.
Другое Observation
Observation

Первичные конечные точки

Estimate the rate of pelvic recurrence at 3 years in patients who are treated with de-escalated adjuvant treatment directed by tumour molecular status [Срок оценки: 3 years]

Вторичные конечные точки (7)

Estimate the rate of isolated vaginal recurrence at 3 years [Срок оценки: 3 years]
Estimate the rate of para-aortic recurrence at 3 years [Срок оценки: 3 years]
Estimate the rate of distant metastasis at 3 years [Срок оценки: 3 years]
Estimate recurrence-free survival [Срок оценки: 9 years]
Estimate endometrial cancer-specific survival [Срок оценки: 9 years]
Estimate overall survival [Срок оценки: 9 years]
Describe the impact of molecular classification on fear of recurrence by Fear of Recurrence Inventory [Срок оценки: 9 years]

Критерии участия

Критерии включения

Patients must have had surgery consisting of hysterectomy and bilateral salpingo-oophorectomy. Lymph node dissection can be performed as per institutional standards. There must be no macroscopic residual disease after surgery.
Patients must have histologically confirmed Stage I to III endometrial carcinoma which can be endometrioid, serous, clear cell, un/dedifferentiated, carcinosarcoma or mixed.
Patients' Eastern Cooperative Group (ECOG) performance status must be 0, 1, or 2.
HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.
Patients' age must be ≥ 18 years.
Patient consent must be appropriately obtained in accordance with applicable local and regulatory requirements.
Patient is able (i.e. sufficiently fluent) and willing to complete the patient-reported outcomes (PRO) questionnaires in either English, French or a validated language
Patients must be accessible for treatment and follow-up. Patients enrolled on this trial must be treated and followed at the participating centre
Protocol treatment is to begin within 10 weeks of hysterectomy/bilateral salpingo-oophorectomy

Критерии исключения

Prior Neoadjuvant chemotherapy for current endometrial cancer diagnosis.
Prior pelvic radiation.
Patients with a history of other malignancies, except: carcinoma in-situ without evidence of invasive disease when resected, adequately treated non-melanoma skin cancer, or other tumours curatively treated with no evidence of disease for ≥ 5 years.
Clinical evidence of distant metastasis as determined by pre-surgical or post-surgical imaging (CT scan of chest, abdomen and pelvis or whole-body PET-CT scan)
Patients with a documented positive surgical margin.
Patients with a documented positive peritoneal washings, if performed.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение: Нерандомизированное
Модель: Параллельные группы
Маскирование: Открытое
Основная цель: Лечение