Observational Study to Evaluate the Use of Targeted Therapies in Metastatic Colorectal Cancer
- Conditions
- Metastatic Colon Cancer
- Interventions
- Biological: Chemotherapy plus monoclonal antibodyDrug: Chemotherapy
- Registration Number
- NCT02254941
- Lead Sponsor
- Grupo Espanol Multidisciplinario del Cancer Digestivo
- Brief Summary
The purpose of this study is to evaluate, in terms of overall survival, the benefit of monoclonal antibodies in the start time of the diagnosis of advanced disease or administer a deferred basis after progression to treatment with chemotherapy alone. Initially expected target population was 1950 patients (pts), in 2015 protocol was ammended to 1028 patients, because the size was sufficient to evaluate the superiority of the use of monoclonal antibodies the start time of the diagnosis against deferred use, with HR of 0.8, power of 90% and an alpha of 0.05. Finally in July 2018, recruitment was completed with a total of 1104 patients enrolled.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 1104
- Patients diagnosed with metastatic colorectal cancer with biopsy positive for adenocarcinoma.
- ECOG PS0-2.
- Who have not received prior chemotherapy treatment for metastatic disease.
- Measurable or evaluable disease.
- No previous surgery for metastatic disease. Surgery for metastasis allowed after inclusion in the study aftercare at the discretion of investigadors.
- Chemotherapy treatment with doublets (CAPOX, FOLFOX, FOLFIRI)
- Patients older than 70 years with frailty criteria.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Experimental: Chemotherapy plus mAb Chemotherapy plus monoclonal antibody Metastatic colon cancer and first line treatment with conventional chemotherapy plus monoclonal antibody Active comparator: Chemotherapy Chemotherapy Metastatic colon cancer and first line treatment with conventional chemotherapy without monoclonal antibody.
- Primary Outcome Measures
Name Time Method Overall survival From July 2018 (LPI), 24 months From date of inclusion until the date of death from any cause.
- Secondary Outcome Measures
Name Time Method Evaluate Sadananda cellular phenotype classification From August 2014, up to 36 months Validate prognostic score GEMCAD From August 2014, up to 36 months The two main prognostic scores for metastatic colorectal cancer (Kohne and GERCOR) do not account for resectability of liver-only metastasis (LiM) and thus are limited as treatment guidance. We propose a classification of patients based on LiM resectability, performance status (PS) and lactate dehydrogenase (LDH) levels and compare its discrimination capacity against Kohne and GERCOR scores.
GEMCAD score: patients are classified as stage 1 if LiM are considered resectable (\<4 nodules and \<5 cm diameter) or potentially resectable (\>4 and \<10 nodules or \>5 cm diameter), PS 0-1 and LDH \< 1.5 ULN; stage 2 if LiM are not resectable or with extrahepatic spread, PS 0-1 and LDH \< 1.5 ULN; stage3 if PS 2 or LDH \> 1.5 ULN.
This score, Kohne, and GERCOR scores will be tested for discrimination using Harrel's C index (HCI, higher is better) and calibration using Akaike information criterion (AIC, smaller is better) of progression-free survival (PFS) and overall survival (OS).To compare GERCOR and Köhne classification with GEMCAD classification From August 2014, up to 36 months The two main prognostic scores for metastatic colorectal cancer (Kohne and GERCOR) do not account for resectability of liver-only metastasis (LiM) and thus are limited as treatment guidance. We propose a classification of patients based on LiM resectability, performance status (PS) and lactate dehydrogenase (LDH) levels and compare its discrimination capacity against Kohne and GERCOR scores.
This score, Kohne, and GERCOR scores will be tested for discrimination using Harrel's C index (HCI, higher is better) and calibration using Akaike information criterion (AIC, smaller is better) of progression-free survival (PFS) and overall survival (OS).Study other variables to identify whether there is group of patients who may benefit from monoclonal antibodies for the treatment of first-line chemotherapy From August 2014, up to 36 months Study whether there are demographic variables, analytical or related tumor and its extension to allow us to identify whether there is group of patients who may benefit from monoclonal antibodies for the treatment of first-line chemotherapy
Trial Locations
- Locations (48)
Hospital Virgen de los Lirios
🇪🇸Alcoy, Alicante, Spain
Hospital General Universitario de Elda
🇪🇸Elda, Alicante, Spain
Hospital Clínico Universitario Lozano Blesa
🇪🇸Zaragoza, Aragon, Spain
Centro Oncologico de Galicia
🇪🇸A Coruña, La Coruña, Spain
Hospital San Pedro de Alcantara Cáceres
🇪🇸Cáceres, Spain
Hospital Arnau de Vilanova de Lleida
🇪🇸Lleida, Spain
Complejo Hospitalario Universitario de Ourense
🇪🇸Ourense, Spain
Hospital General de Vic
🇪🇸Vic, Barcelona, Spain
Hospital Universitario de Gran Canaria Doctor Negrín
🇪🇸Las Palmas de Gran Canaria, Las Palmas, Spain
Hospital Universitari Sagrat Cor
🇪🇸Barcelona, Spain
Instituto Valenciano de Oncologia
🇪🇸Valencia, Spain
Hospital Doctor Peset
🇪🇸Valencia, Spain
Hospital General Universitario de Elche
🇪🇸Elche, Alicante, Spain
Hospital Universitario Virgen del Puerto de Plasencia
🇪🇸Plasencia, Cáceres, Spain
Hospital Universitario de Torrevieja
🇪🇸Torrevieja, Alicante, Spain
Hospital Universitario Puerta de Hierro de Majadahonda
🇪🇸Majadahonda, Madrid, Spain
Hospital Son Espases
🇪🇸Palma, Malllorca, Spain
Hospital General de Ciudad Real
🇪🇸Ciudad Real, Spain
Hospital Granollers
🇪🇸Granollers, Barcelona, Spain
Corporació Sanitària Parc Taulí
🇪🇸Sabadell, Barcelona, Spain
Hospital General de Catalunya
🇪🇸Sant Cugat del Vallès, Barcelona, Spain
Hospital Lluis Alcanyis de Xátiva
🇪🇸Xàtiva, Valencia, Spain
Hosptial de l'Esperit Sant de Barcelona
🇪🇸Barcelona, Spain
Hospital Universitario del Vinalopó
🇪🇸Elche, Alicante, Spain
Hospital de Donostia
🇪🇸San Sebastián, Guipúzcoa, Spain
Hospital Provincial de Pontevedra
🇪🇸Pontevedra, Spain
Hospital de Sagunto
🇪🇸Sagunto, Spain
Complejo Hospitalario Universitario de Vigo
🇪🇸Vigo, Spain
Hospital Universitario Fundación Jiménez Díaz
🇪🇸Madrid, Spain
Hospital La Paz
🇪🇸Madrid, Spain
Clínica Universidad de Navarra
🇪🇸Pamplona, Navarra, Spain
Hospital Plató
🇪🇸Barcelona, Spain
Hospital Universitario Virgen de la Arrixaca
🇪🇸El Palmar, Murcia, Spain
Hospital Althaia
🇪🇸Manresa, Spain
Hospital Morales Meseguer
🇪🇸Murcia, Spain
Hospital de Terrasa
🇪🇸Terrassa, Barcelona, Spain
Hospital de la Santa Creu i Sant Pau
🇪🇸Barcelona, Spain
Hospital Clinic i Provincial
🇪🇸Barcelona, Spain
Hospital Obispo Polanco
🇪🇸Teruel, Zaragoza, Spain
Hospital Infanta Cristina de Badajoz
🇪🇸Badajoz, Spain
Consorcio Hospitalario Provincial de Castellón
🇪🇸Castelló, Spain
Hospital Univeritari Dr. Josep Trueta
🇪🇸Girona, Spain
Centre Mèdic Teknon
🇪🇸Barcelona, Spain
Hospital Universitario y Politécnico de La Fe
🇪🇸Valencia, Spain
Hospital Virgen de la Victoria
🇪🇸Málaga, Spain
Hospital Universitari Son Llàtzer
🇪🇸Palma de mallorca, Spain
Hospital Miguel Servet
🇪🇸Zaragoza, Spain
Hospital Costa del Sol
🇪🇸Marbella, Málaga, Spain