An Observational Study to Evaluate the Safety and Efficacy of FOLFIRI / FOLFOX Plus Cetuximab as First-line Therapy in Patients With KRAS Wild-type Metastatic Colorectal Cancer
Descripción general del estudio
Descripción detallada
Cetuximab, a chimeric immunoglobulin G1 (IgG1) monoclonal antibody, has been found to potentiate the effects of chemotherapy and radiotherapy in experimental systems. The findings from clinical trials suggest a favorable risk-benefit ratio of the combination of irinotecan or oxaliplatin, infusional 5-FU/FA and biweekly cetuximab, and support the current study to demonstrate the therapeutic value of the biweekly cetuximab regimen as a combination partner for those regimens in subjects with KRAS wild-type mCRC in the first-line setting. The purpose of this study is to generate post marketing surveillance (PMS) data for cetuximab in first-line mCRC, which is mandated by the Licensing Authorities.
This is an open-label, non-randomized, prospective, multicentric Phase IV study evaluating FOLFIRI/ FOLFOX plus cetuximab in the first-line therapy of subjects with KRAS wild-type metastatic CRC. The study plans to enroll 100 subjects with KRAS wild type CRC at 20 centres across India. Tumour status, physical and laboratory examinations will be performed during the baseline visit. Subjects will be administered FOLFIRI/ FOLFOX and cetuximab according to the clinical condition in the following treatment visits. Regular safety assessments and all adverse events (AEs) will be documented throughout and until the end-of-study visit. The outcome of AEs ongoing at the final tumour assessment visit will be followed up at the end-of-study visit (If possible, 6 weeks after the last administration of study medication but before second-line anticancer treatment, and not earlier than 30 days after the end of study treatment). Skin toxicity present at the end-of-study visit will be followed up until outcome is known.
OBJECTIVES
Primary Objective:
- To evaluate the safety and tolerability of Cetuximab in combination with standard chemotherapy such as FOLFOX or FOLFIRI as first-line therapy of patients with KRAS wild-type metastatic colorectal cancer.
Secondary Objective:
- To evaluate the efficacy of Cetuximab in combination with standard chemotherapy as first-line therapy of patients with KRAS wild-type metastatic colorectal cancer.
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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Delhi, India, 110055
- Nothern Railway Central Hospital
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Delhi, India, 110076
- Indraprastha Apollo Hospital
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Delhi, India, 110092
- Shanti Mukand Hospital
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Delhi, India, 110096
- Dharamshila Cancer Hospital & Research Centre
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Andhra Pradesh
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Hyderabad, Andhra Pradesh, India, 500034
- Indo- American Cancer Institute & Research Centre
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Hyderabad, Andhra Pradesh, India, 500063
- NVS Ramakrishna's Clinic
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Secunderabad, Andhra Pradesh, India, 500025
- Dr. Nikhil's Clinic
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Secunderabad, Andhra Pradesh, India, 500025
- Nikhil Gharyalpatil's Clinic
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Andrapradesh
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Hyderabad, Andrapradesh, India, 500001
- Ravi Kumar's Clinic
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Hyderabad, Andrapradesh, India, 500008
- Ambaa Hospitals
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Hyderabad, Andrapradesh, India, 500059
- Swarna Sai Hospital
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Bangalore
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Mangalore, Bangalore, India, 575 001
- Manipal Centre For Clinical Research
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Calicut
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Kerala, Calicut, India, 673016
- Medical College Calicut
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Gujarat
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Ahmedabad, Gujarat, India, 380009
- Hemato Oncology Clinic
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Karnataka
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Hubli, Karnataka, India, 580020
- Kattimani Oncology Clinic
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Kashmir
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Srinagar, Kashmir, India, 190001
- SKIMS
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Srinagar, Kashmir, India, 190010
- S. K. I. M. S.
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Madhya Pradesh
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Bhopal, Madhya Pradesh, India, 462001
- Dr. T. P. Sahoo's Clinic
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Maharashtra
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Mumbai, Maharashtra, India, 400014
- BND Onco Centre
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Mumbai, Maharashtra, India, 400071
- Joy Hospital
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Pune, Maharashtra, India, 411001
- Ruby Hall Clinic
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Mizoram
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Aizwal, Mizoram, India, 796 009
- Grace Nursing Home
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Mumbai
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Bandra, Mumbai, India, 400050
- Lilavati Hospital
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Mahim, Mumbai, India, 400016
- S.L.Raheja Hospital
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New Delhi
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Delhi, New Delhi, India, 110044
- Apollo Cancer Institute
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Delhi, New Delhi, India, 110085
- Rajiv Gandhi Cancer Institute & Research
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Punjab
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Amritsar, Punjab, India, 143004
- Fortis Escorts Hospital
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Chandigarh, Punjab, India, 160101
- Dr. Rajeev Bedi's Clinic
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Ludhiana, Punjab, India, 141001
- D.M.C Hospital
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Mohali, Punjab, India, 160071
- IVY Hospital
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Rajasthan
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Jaipur, Rajasthan, India, 302004
- SMS Hospital
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Jaipur, Rajasthan, India, 302004
- Cancer Clinic
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Jaipur, Rajasthan, India, 302006
- Bhagwan Mahaveer Cancer Hospital
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Jaipur, Rajasthan, India, 302030
- Bhagwan Mahaveer Cancer Hospital & Research Centre
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Jodhpur, Rajasthan, India, 3420003
- Vyas Cancer Care
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Tamilnadu
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Trivandrum, Tamilnadu, India, 695011
- TC 14/ 764 Sreemangalam
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Uttar Pradesh
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Ghaziabad, Uttar Pradesh, India, 201014
- Shati Gopal Hospital
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Lucknow, Uttar Pradesh, India, 226007
- Annapurna Medical and Cancer Relief Society
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West Bengal
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Kolkata, West Bengal, India, 700026
- Chittaranjan National Cancer Institute
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Kolkata, West Bengal, India, 700054
- Apollo Gleneagles Cancer Hospital
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- Subjects with histologically confirmed, adenocarcinoma of the colon or rectum (mCRC)
- Subjects with KRAS wild-type status of tumour tissue
- Chemotherapy naïve subjects
- Subject who have signed written informed consent (as per institutional protocol)
Exclusion Criteria:
- As per summary of product characteristics of cetuximab
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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Safety and tolerability evaluated based on the incidence and severity of AEs.
Periodo de tiempo: From baseline to follow-up visit for any ongoing AEs
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From baseline to follow-up visit for any ongoing AEs
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Response rate
Periodo de tiempo: Baseline to End-of-Study Visit
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Disease Control Rate (DCR), Progression Free Survival (PFS)and Overall Survival (OS)
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Baseline to End-of-Study Visit
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Director de estudio: Rajiv Rana, MD, Merck Ltd., India
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
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 (Actual)
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
- Neoplasias por sitio
- Neoplasias Gastrointestinales
- Neoplasias del Sistema Digestivo
- Enfermedades Gastrointestinales
- Enfermedades del Colon
- Enfermedades intestinales
- Neoplasias Intestinales
- Enfermedades Rectales
- Neoplasias
- Neoplasias colorrectales
- Agentes antineoplásicos
- Agentes antineoplásicos inmunológicos
- Cetuximab
Otros números de identificación del estudio
- EMR 062202-517
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