Fruquintinib in Patients With Metastatic Colorectal Cancer
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Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
- Кому может быть актуально
- Состояния в реестре: Metastatic Colorectal Cancer (mCRC). 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
- Германия
- 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
Fruquintinib in Patients With Metastatic Colorectal Cancer: A Prospective, Multicenter, Observational Study
Обзор
FRUQUENT is an observational study in Germany. The goal of the study is to evaluate how well Fruquintinib works to treat patients with metastatic colorectal cancer that have previously been treated with available standard therapies. To this end, it will be analyzed how well patients respond to the therapy in the clinical routine. Further points of interest to the study are survival data, safety data, the use of medical care facilities, and the quality of life of patients treated with Fruquintinib. Participants will be treated as decided by the treating physician and according to their routine practice. FRUQUENT is accompanied by a translational research project combining real-world clinical data with foundational research to stratify patient collectives in regards to the therapeutic benefit of fruquintinib.
Подробное описание
FRUQUENT is a prospective, multicenter, observational study in Germany, collecting real-world data of patients with metastatic colorectal cancer (mCRC) who receive fruquintinib according to the SmPC. The goal of the study is to analyze the effectiveness of the monotherapy with fruquintinib in adult patients with mCRC that have previously been treated with available standard therapies, including fluoropyrimidine, oxaliplatin-, and irintecan-based chemotherapies, anti-VEGF agents, and, if RAS wild-type, anti-EGFR agents. Moreover, the patients must have progressed on or be intolerant to treatment with either trifluridine/tipiracil or regorafenib.
All data for FRUQUENT will be obtained in routine clinical practice, allowing for a representative evaluation of the effectiveness of fruquintinib in a real-world setting. The study aims to recruit 150 patients in 50 practices (office based, oncology outpatient-centers or hospitals) to facilitate robust data.
The companion translational research project "FRUQUENT FUTURE" aims to identify patient collectives that benefit the most from a therapy with fruquintinib. To this end, archival tumor tissue and whole blood from routine blood draws is collected. Real-world clinical data on effectiveness is correlated with biomarker profiles of tumor tissues to determine biomarkers that are indicative of a response to fruquintinib. Longitudinal monitoring of circulating tumor DNA (ctDNA) will allow for an investigation of ctDNA as an indicator of benefit and response to fruquintinib.
Первичные конечные точки
- Real-world disease control rate (RW DCR) [Срок оценки: Start of treatment to end of treatment (avg. 6 months)]
Вторичные конечные точки (12)
- Best response [Срок оценки: Start of treatment to end of treatment (avg. 6 months)]
- Overall response rate (ORR) [Срок оценки: Start of treatment to end of treatment (avg. 6 months)]
- Time to treatment failure (TTF) [Срок оценки: Start of treatment to end of treatment (avg. 6 months)]
- Time to next treatment (TTNT) [Срок оценки: Start of treatment to start of subsequent antineoplastic therapy (max. 33 months)]
- Progression-free survival (PFS) [Срок оценки: Start of treatment to disease progression or death (max. 33 months)]
- Overall survival (OS) [Срок оценки: Start of treatment to death (max. 33 months)]
- Adverse events (AEs) and serious adverse events (SAEs) according to NCI CTCAE [Срок оценки: Start of treatment until 30 days after end of fruquintinib treatment (avg. 7 months)]
- Adverse drug reaction (ADR) and serious adverse drug reactions (SADR) related to fruquintinib [Срок оценки: Start of treatment to 30 days after end of fruquintinib treatment (avg. 7 months)]
- Quality of life (QoL): Absolute values over time from baseline to end of study [Срок оценки: Baseline to (individual) end of study (max. 33 months)]
- Quality of life (QoL): Change from baseline over time to end of study [Срок оценки: Baseline to (individual) end of study (max. 33 months)]
- Quality of life (QoL): Time to definitive deterioration (TTD) [Срок оценки: Baseline to (individual) end of study (max. 33 months)]
- Frequency of parameters affecting physicians' treatment decision making [Срок оценки: Baseline]
Критерии участия
Критерии включения
- Aged 18 years or older.
- Indication and decision for therapy with fruquintinib in accordance with the current German SmPC of fruquintinib as monotherapy for patients with mCRC.
- Prior treatment with available standard therapies, including fluoropyrimidine-, oxaliplatin-, and irinotecan based chemotherapies, anti VEGF therapy, and if RAS wild-type, anti EGFR therapy.
- Progression on or intolerance to treatment with either trifluridine/tipiracil and/or regorafenib.
- Other criteria according to current SmPC.
- Signed written informed consent.\* \* Patients are allowed to be enrolled up to 6 weeks after their first dose of fruquintinib. These patients cannot participate in the PRO assessments.
Критерии исключения
- Participation in an interventional clinical trial (except follow-up) within 30 days prior to enrollment or start of treatment with fruquintinib, whatever comes first.
- Contraindications according to current SmPC.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
Германия · 1 центр
- Onkologische Schwerpunktpraxis — Hanover
Идентификаторы
NCT: NCT06787105 · iOM-100523