IXO+A in mCRC With Liver-only Metastases
A Single-arm Phase II Downsizing Study of Irinotecan, Capecitabine and Oxaliplatin (IXO) and Bevacizumab as First-line Treatment to Assess Conversion to Resectability of Liver-only Metastases in Colorectal Cancer Patients With Initially Unresectable Metastases
The percentage of patients with defined unresectable metastatic disease who will benefit from a first-line treatment enabling secondary complete metastasectomy is unknown but limited. Definition of optimized treatment algorithms is difficult due to very inhomogeneous patient populations.
This open label, multicentre Phase II study primarily aims to assess the resection rate achievable in a selected patient population with initially unresectable metastatic disease limited to the liver only in order to evaluate feasibility, safety and efficacy with regards to secondary resection of hepatic lesions in these patients.
The trial aims to enrol only patients meeting defined criteria of unresectability with regards to their hepatic lesions and will exclude patients with extrahepatic lesions in order to examine the most appropriate, highly active treatment regimen for this group of unresectable patients with the highest probability of a successful secondary metastasectomy with curative intent. The trial will be conducted in highly specialized centres with a track record of successful interdisciplinary treatment approaches in the field of metastatic colorectal cancer to allow the precise assessment of the peri-operative safety parameters as well as an evaluation of the surgical treatment approaches.
The IXO regimen selected for this study has shown in a phase I/II study promising efficacy and a favourable safety profile. Bevacizumab has demonstrated a significant survival benefit in combination with chemotherapy in metastatic colorectal cancer. Therefore the study will allow evaluation of its potential benefit in combination with the two most active current chemotherapy regimens in the first-line and post-operative treatment setting.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Fase
- Fase 2
Contactos y Ubicaciones
Ubicaciones de estudio
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Ontario
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Ottawa, Ontario, Canadá, K1H 8L6
- The Ottawa Hospital Cancer Center
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Toronto, Ontario, Canadá, M4N 3M5
- Sunnybrook Health Sciences Centre
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Toronto, Ontario, Canadá, M5T 2S8
- University Health Network
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Quebec
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Montreal, Quebec, Canadá, H3A 1A1
- McGill University Health Centre
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-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Primary colorectal cancer with unresectable metastatic lesion(s)
- At least one measurable lesion, confirmed by CT scan
- Male and female patients, aged ≥ 18 years
- ECOG performance score of 0 or 1 (within 1 week of study treatment start)
- Written informed consent
- Adequate general condition, cardiopulmonary functions and performance status
- Liver metastases no initially foreseen R0 resection of all hepatic lesions, but deemed potentially resectable after response to downsizing therapy
Exclusion Criteria:
- Extrahepatic metastatic disease
- Prior systemic or local treatment for metastatic disease, prior therapy with a biologic agent, prior adjuvant or neo-adjuvant chemotherapy, prior radiotherapy to the liver, other concurrent chemotherapy
- Inadequate bone marrow, liver, renal function, uncontrolled hypertension
- Pregnancy or lactation
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: IXO+A
IXO regimen with Avastin
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IXO plus bevacizumab regimen is given every 3 weeks (Q3W), in the following order: Bevacizumab (A): 7.5 mg/kg via IV infusion, day 1 Oxaliplatin (O): 100 mg/m2 via 2-hour IV infusion, day 1 Irinotecan (I): 160 mg/m2 via 1-hour IV infusion, day 1 Capecitabine (X): 950 mg/m2 twice daily PO, days 2 - 15
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
conversion to resectability during downsizing therapy with IXO+A patients with initially unresectable liver-only metastases associated with colorectal cancer
Periodo de tiempo: after 8 IXO+A cycles
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after 8 IXO+A cycles
|
Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
Recurrence-free survival (RFS)
Periodo de tiempo: Every 2 cycles
|
Every 2 cycles
|
|
Progression-free survival (PFS)
Periodo de tiempo: Every 2 cycles
|
Every 2 cycles
|
|
Time to response (TTR)
Periodo de tiempo: Every 2 cycles
|
Every 2 cycles
|
|
Overall survival (OS)
Periodo de tiempo: Every 2 cycles
|
Every 2 cycles
|
|
Pathological complete response (pCR) rate
Periodo de tiempo: assessed post-operatory
|
assessed post-operatory
|
|
Overall response rate (ORR)
Periodo de tiempo: Every 2 cycles
|
Every 2 cycles
|
|
Number of participants with Adverse Events as a measure of Safety and Tolerability
Periodo de tiempo: Every 3 weeks
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Every 3 weeks
|
|
Surgical safety (frequency of surgical complications)
Periodo de tiempo: assessed post-operatory
|
assessed post-operatory
|
|
Pathological changes in the non-tumoural liver following therapy with IXO+A
Periodo de tiempo: assessed post-operatory
|
assessed post-operatory
|
|
R0, R1, R2 resection rate after up to 8 cycles of downsizing therapy with IXO+A
Periodo de tiempo: assessed post-operatory
|
assessed post-operatory
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Silla de estudio: Jean Maroun, MD, The Ottawa Hospital Cancer Centre
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades del Sistema Digestivo
- Procesos Patológicos
- Neoplasias
- Neoplasias por sitio
- Neoplasias Gastrointestinales
- Neoplasias del Sistema Digestivo
- Enfermedades Gastrointestinales
- Enfermedades del Colon
- Enfermedades intestinales
- Neoplasias Intestinales
- Enfermedades Rectales
- Procesos Neoplásicos
- Neoplasias colorrectales
- Metástasis de neoplasias
- Efectos fisiológicos de las drogas
- Mecanismos moleculares de acción farmacológica
- Inhibidores de enzimas
- Antimetabolitos, Antineoplásicos
- Antimetabolitos
- Agentes antineoplásicos
- Inhibidores de la topoisomerasa
- Agentes antineoplásicos inmunológicos
- Inhibidores de la angiogénesis
- Agentes moduladores de la angiogénesis
- Sustancias de crecimiento
- Inhibidores del crecimiento
- Inhibidores de la topoisomerasa I
- Capecitabina
- Oxaliplatino
- Bevacizumab
- Irinotecán
Otros números de identificación del estudio
- OTT 10-01
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