Clinical trial NCT02254941: Observational Study to Evaluate the Use of Targeted Therapies in Metastatic Colorectal Cancer
Official title: Observational Study to Evaluate the Use of Targeted Therapies in Metastatic Colorectal Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Metastatic Colon Cancer
Keywords: Metastatic Colon Cancer
Monoclonal antibodies
Chemotherapy
First line
Lead sponsor: Grupo Espanol Multidisciplinario del Cancer Digestivo
Sponsor class: OTHER
First posted: 2014-10-02
Enrollment: 1104
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Metastatic colorectal cancer. Adenocarcinoma. First line treatment

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.


Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* Patients older than 70 years with frailty criteria.

Primary outcomes:
measure: Overall survival
timeFrame: From July 2018 (LPI), 24 months
Secondary outcomes:
measure: Validate prognostic score GEMCAD
timeFrame: From August 2014, up to 36 months
measure: To compare GERCOR and Köhne classification with GEMCAD classification
timeFrame: From August 2014, up to 36 months
measure: Evaluate Sadananda cellular phenotype classification
timeFrame: From August 2014, up to 36 months
measure: Study other variables to identify whether there is group of patients who may benefit from monoclonal antibodies for the treatment of first-line chemotherapy
timeFrame: From August 2014, up to 36 months
Other outcomes:
Locations:
city: Alcoy
country: Spain
facility: Hospital Virgen de los Lirios
state: Alicante
city: Elche
country: Spain
facility: Hospital General Universitario de Elche
state: Alicante
city: Elche
country: Spain
facility: Hospital Universitario del Vinalopó
state: Alicante
city: Elda
country: Spain
facility: Hospital General Universitario de Elda
state: Alicante
city: Torrevieja
country: Spain
facility: Hospital Universitario de Torrevieja
state: Alicante
city: Zaragoza
country: Spain
facility: Hospital Clínico Universitario Lozano Blesa
state: Aragon
city: Granollers
country: Spain
facility: Hospital Granollers
state: Barcelona
city: Sabadell
country: Spain
facility: Corporació Sanitària Parc Taulí
state: Barcelona
city: Sant Cugat del Vallès
country: Spain
facility: Hospital General de Catalunya
state: Barcelona
city: Terrassa
country: Spain
facility: Hospital de Terrasa
state: Barcelona
city: Vic
country: Spain
facility: Hospital General de Vic
state: Barcelona
city: Plasencia
country: Spain
facility: Hospital Universitario Virgen del Puerto de Plasencia
state: Cáceres
city: San Sebastián
country: Spain
facility: Hospital de Donostia
state: Guipúzcoa
city: A Coruña
country: Spain
facility: Centro Oncologico de Galicia
state: La Coruña
city: Las Palmas de Gran Canaria
country: Spain
facility: Hospital Universitario de Gran Canaria Doctor Negrín
state: Las Palmas
city: Majadahonda
country: Spain
facility: Hospital Universitario Puerta de Hierro de Majadahonda
state: Madrid
city: Palma
country: Spain
facility: Hospital Son Espases
state: Malllorca
city: El Palmar
country: Spain
facility: Hospital Universitario Virgen de la Arrixaca
state: Murcia
city: Marbella
country: Spain
facility: Hospital Costa del Sol
state: Málaga
city: Pamplona
country: Spain
facility: Clínica Universidad de Navarra
state: Navarra
city: Xàtiva
country: Spain
facility: Hospital Lluis Alcanyis de Xátiva
state: Valencia
city: Teruel
country: Spain
facility: Hospital Obispo Polanco
state: Zaragoza
city: Badajoz
country: Spain
facility: Hospital Infanta Cristina de Badajoz
city: Barcelona
country: Spain
facility: Centre Mèdic Teknon
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
city: Barcelona
country: Spain
facility: Hosptial de l'Esperit Sant de Barcelona
city: Barcelona
country: Spain
facility: Hospital Clinic i Provincial
city: Barcelona
country: Spain
facility: Hospital Plató
city: Barcelona
country: Spain
facility: Hospital Universitari Sagrat Cor
city: Castelló
country: Spain
facility: Consorcio Hospitalario Provincial de Castellón
city: Ciudad Real
country: Spain
facility: Hospital General de Ciudad Real
city: Cáceres
country: Spain
facility: Hospital San Pedro de Alcantara Cáceres
city: Girona
country: Spain
facility: Hospital Univeritari Dr. Josep Trueta
city: Lleida
country: Spain
facility: Hospital Arnau de Vilanova de Lleida
city: Madrid
country: Spain
facility: Hospital Universitario Fundación Jiménez Díaz
city: Madrid
country: Spain
facility: Hospital La Paz
city: Manresa
country: Spain
facility: Hospital Althaia
city: Murcia
country: Spain
facility: Hospital Morales Meseguer
city: Málaga
country: Spain
facility: Hospital Virgen de la Victoria
city: Ourense
country: Spain
facility: Complejo Hospitalario Universitario de Ourense
city: Palma de mallorca
country: Spain
facility: Hospital Universitari Son Llàtzer
city: Pontevedra
country: Spain
facility: Hospital Provincial de Pontevedra
city: Sagunto
country: Spain
facility: Hospital de Sagunto
city: Valencia
country: Spain
facility: Instituto Valenciano de Oncologia
city: Valencia
country: Spain
facility: Hospital Doctor Peset
city: Valencia
country: Spain
facility: Hospital Universitario y Politécnico de La Fe
city: Vigo
country: Spain
facility: Complejo Hospitalario Universitario de Vigo
city: Zaragoza
country: Spain
facility: Hospital Miguel Servet
Study officials:
affiliation: Hospital Clinic of Barcelona
name: Joan Maurel, MD PhD
role: STUDY_CHAIR
References: