FOLICOLOR TRIAL: Following Therapy Response Through Liquid Biopsy in Metatstatic Colorectal Cancer Patients (FOLICOLOR)
Обзор исследования
Статус
Условия
Вмешательство/лечение
Подробное описание
FOLICOLOR is a prospective, randomized, open-label, multicentric phase 3 study evaluating the clinical value of ctDNA-based liquid biopsy in the follow-up of patients receiving first-line therapy for metastatic colorectal cancer.
Patients with confirmed NPY methylation-based ctDNA positivity on an initial liquid biopsy sample will be randomized into two study arms:
- Control arm (CT arm): Treatment decisions are guided by radiographic evaluation using conventional CT scans.
- Study arm (LB arm): Treatment decisions are guided by serial liquid biopsy results.
All patients are followed per study protocol for 18 months from the time of inclusion.
Primary Objective:
To determine whether a liquid biopsy-guided follow-up strategy preserves quality of life (QoL) for longer, by enabling earlier detection of disease progression and more timely therapeutic adjustments, thereby reducing exposure to ineffective treatment and associated toxicity.
Secondary Objectives:
- To evaluate whether liquid biopsy allows earlier detection of progressive disease compared to conventional CT imaging (per RECIST 1.1 criteria).
- To assess time to progression and progression-free survival (PFS) in both the LB arm and CT arm, with progression defined as progressive disease (PD) per RECIST 1.1.
- To evaluate the difference in 3-year overall survival (OS) between both study arms.
Тип исследования
Регистрация (Оцененный)
Фаза
- Фаза 3
Контакты и местонахождение
Контакты исследования
- Имя: Sanne Wouters
- Номер телефона: 003238212441
- Электронная почта: sanne.wouters@uza.be
Учебное резервное копирование контактов
- Имя: Ayla Wyninckx
- Номер телефона: 003232759745
- Электронная почта: ayla.wyninckx@uza.be
Места учебы
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Antwerp
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Brasschaat, Antwerp, Бельгия, 2930
- Рекрутинг
- AZ Klina
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Edegem, Antwerp, Бельгия, 2650
- Рекрутинг
- University Hospital Antwerp
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Wilrijk, Antwerp, Бельгия, 2610
- Рекрутинг
- Sint-Augustinus (ZAS)
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Antwerpen
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Mechelen, Antwerpen, Бельгия, 2800
- Рекрутинг
- AZ Sint Maarten
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Henegouwen
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Charleroi, Henegouwen, Бельгия, 6020
- Рекрутинг
- Grand Hôpital de Charleroi
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Oost-Vlaanderen
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Ghent, Oost-Vlaanderen, Бельгия, 9000
- Рекрутинг
- AZ Maria Middelares, Ghent
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Sint-Niklaas, Oost-Vlaanderen, Бельгия, 9100
- Рекрутинг
- Vitaz
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West-Vlaanderen
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Bruges, West-Vlaanderen, Бельгия, 8000
- Рекрутинг
- AZ Sint Lucas, Brugge
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Kortrijk, West-Vlaanderen, Бельгия, 8500
- Рекрутинг
- AZ Groeninge, Kortrijk
-
-
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Описание
Inclusion Criteria:
- Man or woman ≥ 18 years of age at the time the informed consent is obtained
- ECOG performance status of 0-2
- Histologically or cytologically confirmed adenocarcinoma of the colon or rectum in subjects with unresectable metastatic (M1) disease
- There should be at least 1 uni-dimensionally measurable (min. 10mm) using conventional crosssectional imaging techniques (CT or MRI scan). Lesion must not be chosen from a previously irradiated field, unlessnthere has been documented disease progression in that field after irradiation and prior to randomization. All sites of disease must be evaluated ≤ 28 days prior to randomization
- Adequate hematology, renal, hepatic and coagulation function (at treating physician's discretion)
- Adequate blood results for treatment (at treating physician's discretion)
- Starting a first line treatment
Exclusion Criteria:
- History of prior or concurrent central nervous system metastases
- History of other malignancy, except:
Malignancy treated with curative intent and with no known active disease present for ≥ 3 years prior to randomization and felt to be at low risk for recurrence by the treating physician.
Adequately treated non-melanomatous skin cancer or lentigo maligna without evidence of disease.
Adequately treated cervical carcinoma in situ without evidence of disease. Prostatic intraepithelial neoplasia without evidence of prostate cancer
- Prior chemotherapy or other systemic anticancer therapy for the treatment of metastatic colorectal carcinoma including but not limited to bevacizumab and anti-EGFR therapy (e.g. cetuximab, panitumumab, erlotinib, gefitinib, lapatinib)
- Prior adjuvant chemotherapy (including oxaliplatin therapy) or other adjuvant systemic anticancer therapy including but not limited to bevacizumab and anti-EGFR therapy (e.g. cetuximab, panitumumab, erlotinib, gefitinib, lapatinib) for the treatment of colorectal cancer ≤ 6 months prior to randomization with the following exceptions: Subjects may have received prior fluoropyrimidine therapy if administered solely for the purpose of radiosensitization for the adjuvant or neoadjuvant treatment of rectal cancer.
- Radiotherapy ≤ 14 days prior to randomization. Subjects must have recovered from all radiotherapy-related toxicities.
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Другой
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Одинокий
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
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Без вмешательства: CT arm
Treatment decision guided by radiographic evaluation following the standard of care of the treating hospital.
(Control arm)
|
|
|
Экспериментальный: Liquid Biopsy arm
Treatment decision guided by liquid biopsies.
(intervention arm)
|
The LB arm is the intervention group where the evaluation of therapy is guided by Liquid Biopsy results
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Time to Deterioration (TTD) in Quality of Life (QoL)
Временное ограничение: 18 months
|
The primary objective of this study is to determine whether the technique of monitoring patients with liquid biopsies can ensure that patients experience a slower decline in their quality of life (and can therefore maintain a good quality of life for longer). This will be evaluated through the difference in time to deterioration (TTD) in Quality of Life (QoL) between patients in which follow-up is done based on the results of LBs (LB-arm) in comparison to the patients in which follow-up is done based on the conventional follow-up techniques (CT-arm). TTD is defined as time from randomization to the first decrease from baseline on the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life questionnaire (QLQ-CR29) summary score by at least 10 percent. |
18 months
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Progression Free Survival (PFS)
Временное ограничение: 18 months
|
To compare progresion free survival between the LB-arm and the CT-arm (progression is defined as PD on CT scan according to RECIST 1.1 criteria).
|
18 months
|
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3 year overall survival
Временное ограничение: 3 year
|
To evaluate the 3-year overall survival difference between both study arms.
|
3 year
|
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Earlier detection of progressive disease with liquid biospies
Временное ограничение: 18 months
|
The proportion of patients in which progressive disease can be detected earlier based on the results of liquid biopsies in comparison to conventional CT scans (with RECIST 1.1 measurements).
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18 months
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Соавторы и исследователи
Спонсор
Соавторы
Следователи
- Главный следователь: Timon Vandamme, University Hospital, Antwerp
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Другие идентификационные номера исследования
- 20/04/040
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
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