Prospective National Cohort Evaluating Prognostic Factors for Efficacy of Fruquintinib Treatment in Patients With Metastatic Colorectal 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: Fruquintinib.
- Кому может быть актуально
- Состояния в реестре: Metastatic Colorectal Cancer (CRC), Antineoplastic Agents, Immunological, VEGFR-TKI. 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
- Франция
- 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
PRODIGE 108 - COHORTE 2320 - COFRUQ Prospective National Cohort Evaluating Prognostic Factors for Efficacy of Fruquintinib Treatment in Patients With Metastatic Colorectal Cancer
Обзор
The main objective of this study is to identify the prognostic factors (clinico-biological) for the efficacy (overall survival) of fruquintinib in patients with metastatic colorectal cancer.
Подробное описание
Fruquintinib (a novel, highly selective oral tyrosine kinase inhibitor targeting VEGFR-1, -2, and -3) has demonstrated efficacy in chemotherapy-resistant metastatic colorectal cancer (mCRC) in two phase III trials, FRESCO and FRESCO-2. In France, fruquintinib has been available through compassionate use since January 16, 2024, for all patients with chemotherapy-refractory mCRC, and its reimbursement is expected in the coming months. However, limited real-world data are currently available regarding the use of this new treatment and the identification of predictive factors of its efficacy, both clinically and biologically.
Moreover, there is a significant lack of information concerning older patients (≥70 years), who are often underrepresented in registration trials. This cohort will therefore provide a unique opportunity to gather specific data in elderly patients, including the integration of geriatric assessment parameters.
The main objectives of this cohort will be to validate, in routine clinical practice, the survival and safety outcomes observed in the FRESCO-2 trial, and to identify clinical and biological prognostic and predictive factors of survival in patients treated with fruquintinib.
As such, the COFRUQ cohort could help identify patients who derive the greatest survival benefit from fruquintinib and thereby contribute to optimizing their therapeutic pathway.
Вмешательства
- Препарат Fruquintinib
Fruquintinib will be administered according to the summary of product characteristics (SmPC) : 5 mg, 21 days of treatment followed by a 7-day break until progression, unacceptable toxicity, death, or patient refusal.
Первичные конечные точки
- overall survival [Срок оценки: up to 1 year after treatment start]
Вторичные конечные точки (1)
- progression free survival [Срок оценки: up to 1 year after treatment start]
Критерии участия
Критерии включения
- Patients aged 18 and over.
- Histologically confirmed colorectal adenocarcinoma with locally advanced disease and/or unresectable metastasis(es) receiving treatment with fruquintinib under i) compassionate/early access and ii) marketing authorisation and reimbursement in France.
- Obtain informed consent from the patient for the clinical-biological cohort.
- Agreement to take biological samples of ctDNA and send tumour blocks (patient participation in the pharmacokinetic study remains optional).
Критерии исключения
- Patient with another concurrent cancer at the time of diagnosis, requiring systemic treatment or influencing prognosis (in the opinion of the centre's medical team).
- Contraindication due to psychological or social reasons that may hinder follow-up (cognitive deficit, psychological disorders incompatible with obtaining consent; inability to be followed in the same centre throughout the follow-up period for geographical reasons).
- Pregnant or breast-feeding women.
- Patients under court protection or subject to a protective measure (patient under guardianship or curatorship).
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
- Другое
Центры проведения
Франция · 83 центра
- Poitiers CHU — Poitiers
- Centre Hospitalier — Albi
- CHU — Amiens
- Clinique de L Europe — Amiens
- Centre Hospitalier — Annecy
- Centre Hospitalier — Aurillac
- Centre Hospitalier — Bayeux
- Centre Hospitalier — Bayonne
- … и ещё 75 центров
Идентификаторы
NCT: NCT07124858 · COFRUQ COHORT · 2024-A00994-43