FOLICOLOR TRIAL: Following Therapy Response Through Liquid Biopsy in Metatstatic Colorectal Cancer Patients (FOLICOLOR)
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Estimado)
Fase
- Fase 3
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Sanne Wouters
- Número de teléfono: 003238212441
- Correo electrónico: sanne.wouters@uza.be
Copia de seguridad de contactos de estudio
- Nombre: Ayla Wyninckx
- Número de teléfono: 003232759745
- Correo electrónico: ayla.wyninckx@uza.be
Ubicaciones de estudio
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Antwerp
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Brasschaat, Antwerp, Bélgica, 2930
- Reclutamiento
- AZ Klina
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Edegem, Antwerp, Bélgica, 2650
- Reclutamiento
- University Hospital Antwerp
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Wilrijk, Antwerp, Bélgica, 2610
- Reclutamiento
- Sint-Augustinus (ZAS)
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Antwerpen
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Mechelen, Antwerpen, Bélgica, 2800
- Reclutamiento
- AZ Sint Maarten
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Henegouwen
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Charleroi, Henegouwen, Bélgica, 6020
- Reclutamiento
- Grand Hôpital de Charleroi
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Oost-Vlaanderen
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Ghent, Oost-Vlaanderen, Bélgica, 9000
- Reclutamiento
- AZ Maria Middelares, Ghent
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Sint-Niklaas, Oost-Vlaanderen, Bélgica, 9100
- Reclutamiento
- Vitaz
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West-Vlaanderen
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Bruges, West-Vlaanderen, Bélgica, 8000
- Reclutamiento
- AZ Sint Lucas, Brugge
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Kortrijk, West-Vlaanderen, Bélgica, 8500
- Reclutamiento
- AZ Groeninge, Kortrijk
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Sin intervención: CT arm
Treatment decision guided by radiographic evaluation following the standard of care of the treating hospital.
(Control arm)
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|
|
Experimental: 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
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Time to Deterioration (TTD) in Quality of Life (QoL)
Periodo de tiempo: 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
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Progression Free Survival (PFS)
Periodo de tiempo: 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).
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18 months
|
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3 year overall survival
Periodo de tiempo: 3 year
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To evaluate the 3-year overall survival difference between both study arms.
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3 year
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Earlier detection of progressive disease with liquid biospies
Periodo de tiempo: 18 months
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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
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Timon Vandamme, University Hospital, Antwerp
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- 20/04/040
Información sobre medicamentos y dispositivos, documentos del estudio
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Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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