Observational Study to Evaluate the Use of Targeted Therapies in Metastatic Colorectal Cancer
1 other identifier
observational
1,104
1 country
48
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2014
Longer than P75 for all trials
48 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2014
CompletedFirst Submitted
Initial submission to the registry
September 23, 2014
CompletedFirst Posted
Study publicly available on registry
October 2, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2022
CompletedMarch 16, 2022
March 1, 2022
8.3 years
September 23, 2014
March 15, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall survival
From date of inclusion until the date of death from any cause.
From July 2018 (LPI), 24 months
Secondary Outcomes (4)
Validate prognostic score GEMCAD
From August 2014, up to 36 months
To compare GERCOR and Köhne classification with GEMCAD classification
From August 2014, up to 36 months
Evaluate Sadananda cellular phenotype classification
From August 2014, up to 36 months
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 Arms (2)
Active comparator: Chemotherapy
Metastatic colon cancer and first line treatment with conventional chemotherapy without monoclonal antibody.
Experimental: Chemotherapy plus mAb
Metastatic colon cancer and first line treatment with conventional chemotherapy plus monoclonal antibody
Interventions
Metastatic colon cancer, first line treatment with conventional chemotherapy
Metastatic colon cancer, first line treatment with conventional chemotherapy plus monoclonal antibody
Eligibility Criteria
Metastatic colorectal cancer. Adenocarcinoma. First line treatment
You may qualify if:
- 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.
- Chemotherapy treatment with doublets (CAPOX, FOLFOX, FOLFIRI)
You may not qualify if:
- Patients older than 70 years with frailty criteria.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (48)
Hospital Virgen de los Lirios
Alcoy, Alicante, Spain
Hospital General Universitario de Elche
Elche, Alicante, 03203, Spain
Hospital Universitario del Vinalopó
Elche, Alicante, Spain
Hospital General Universitario de Elda
Elda, Alicante, Spain
Hospital Universitario de Torrevieja
Torrevieja, Alicante, Spain
Hospital Clínico Universitario Lozano Blesa
Zaragoza, Aragon, 50009, Spain
Hospital Granollers
Granollers, Barcelona, Spain
Corporació Sanitària Parc Taulí
Sabadell, Barcelona, Spain
Hospital General de Catalunya
Sant Cugat del Vallès, Barcelona, 08190, Spain
Hospital de Terrasa
Terrassa, Barcelona, Spain
Hospital General de Vic
Vic, Barcelona, Spain
Hospital Universitario Virgen del Puerto de Plasencia
Plasencia, Cáceres, 10600, Spain
Hospital de Donostia
San Sebastián, Guipúzcoa, 20014, Spain
Centro Oncologico de Galicia
A Coruña, La Coruña, 15009, Spain
Hospital Universitario de Gran Canaria Doctor Negrín
Las Palmas de Gran Canaria, Las Palmas, 35010, Spain
Hospital Universitario Puerta de Hierro de Majadahonda
Majadahonda, Madrid, 28222, Spain
Hospital Son Espases
Palma, Malllorca, Spain
Hospital Universitario Virgen de la Arrixaca
El Palmar, Murcia, 30120, Spain
Hospital Costa del Sol
Marbella, Málaga, Spain
Clínica Universidad de Navarra
Pamplona, Navarre, 31008, Spain
Hospital Lluis Alcanyis de Xátiva
Xàtiva, Valencia, Spain
Hospital Obispo Polanco
Teruel, Zaragoza, Spain
Hospital Infanta Cristina de Badajoz
Badajoz, Spain
Centre Mèdic Teknon
Barcelona, 08022, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, 08025, Spain
Hosptial de l'Esperit Sant de Barcelona
Barcelona, 08923, Spain
Hospital Clinic i Provincial
Barcelona, Spain
Hospital Plató
Barcelona, Spain
Hospital Universitari Sagrat Cor
Barcelona, Spain
Consorcio Hospitalario Provincial de Castellón
Castelló, 12002, Spain
Hospital San Pedro de Alcantara Cáceres
Cáceres, 10003, Spain
Hospital General de Ciudad Real
Ciudad Real, 13005, Spain
Hospital Univeritari Dr. Josep Trueta
Girona, Spain
Hospital Arnau de Vilanova de Lleida
Lleida, 25198, Spain
Hospital Universitario Fundación Jiménez Díaz
Madrid, 28040, Spain
Hospital La Paz
Madrid, Spain
Hospital Althaia
Manresa, Spain
Hospital Virgen de la Victoria
Málaga, 29010, Spain
Hospital Morales Meseguer
Murcia, 30008, Spain
Complejo Hospitalario Universitario de Ourense
Ourense, 32005, Spain
Hospital Universitari Son Llàtzer
Palma de Mallorca, 08198, Spain
Hospital Provincial de Pontevedra
Pontevedra, 36002, Spain
Hospital de Sagunto
Sagunto, Spain
Instituto Valenciano de Oncologia
Valencia, 46009, Spain
Hospital Doctor Peset
Valencia, 46017, Spain
Hospital Universitario y Politécnico de La Fe
Valencia, 46026, Spain
Complejo Hospitalario Universitario de Vigo
Vigo, 36036, Spain
Hospital Miguel Servet
Zaragoza, Spain
Biospecimen
Colon biopsy
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Joan Maurel, MD PhD
Hospital Clinic of Barcelona
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 23, 2014
First Posted
October 2, 2014
Study Start
August 1, 2014
Primary Completion
December 1, 2022
Study Completion
December 1, 2022
Last Updated
March 16, 2022
Record last verified: 2022-03