Observational Study to Evaluate the Use of Targeted Therapies in Metastatic Colorectal Cancer

NCT ID: NCT02254941

Last Updated: 2022-03-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

1104 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-08-31

Study Completion Date

2022-12-31

Brief Summary

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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

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Conditions

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Metastatic Colon Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Active comparator: Chemotherapy

Metastatic colon cancer and first line treatment with conventional chemotherapy without monoclonal antibody.

Chemotherapy

Intervention Type DRUG

Metastatic colon cancer, first line treatment with conventional chemotherapy

Experimental: Chemotherapy plus mAb

Metastatic colon cancer and first line treatment with conventional chemotherapy plus monoclonal antibody

Chemotherapy plus monoclonal antibody

Intervention Type BIOLOGICAL

Metastatic colon cancer, first line treatment with conventional chemotherapy plus monoclonal antibody

Interventions

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Chemotherapy

Metastatic colon cancer, first line treatment with conventional chemotherapy

Intervention Type DRUG

Chemotherapy plus monoclonal antibody

Metastatic colon cancer, first line treatment with conventional chemotherapy plus monoclonal antibody

Intervention Type BIOLOGICAL

Other Intervention Names

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Standard Chemotherapy Standard CHemotherapy plus monoclonal antibody

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Grupo Espanol Multidisciplinario del Cancer Digestivo

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Joan Maurel, MD PhD

Role: STUDY_CHAIR

Hospital Clinic of Barcelona

Locations

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Hospital Virgen de los Lirios

Alcoy, Alicante, Spain

Site Status

Hospital General Universitario de Elche

Elche, Alicante, Spain

Site Status

Hospital Universitario del Vinalopó

Elche, Alicante, Spain

Site Status

Hospital General Universitario de Elda

Elda, Alicante, Spain

Site Status

Hospital Universitario de Torrevieja

Torrevieja, Alicante, Spain

Site Status

Hospital Clínico Universitario Lozano Blesa

Zaragoza, Aragon, Spain

Site Status

Hospital Granollers

Granollers, Barcelona, Spain

Site Status

Corporació Sanitària Parc Taulí

Sabadell, Barcelona, Spain

Site Status

Hospital General de Catalunya

Sant Cugat del Vallès, Barcelona, Spain

Site Status

Hospital de Terrasa

Terrassa, Barcelona, Spain

Site Status

Hospital General de Vic

Vic, Barcelona, Spain

Site Status

Hospital Universitario Virgen del Puerto de Plasencia

Plasencia, Cáceres, Spain

Site Status

Hospital de Donostia

San Sebastián, Guipúzcoa, Spain

Site Status

Centro Oncologico de Galicia

A Coruña, La Coruña, Spain

Site Status

Hospital Universitario de Gran Canaria Doctor Negrín

Las Palmas de Gran Canaria, Las Palmas, Spain

Site Status

Hospital Universitario Puerta de Hierro de Majadahonda

Majadahonda, Madrid, Spain

Site Status

Hospital Son Espases

Palma, Malllorca, Spain

Site Status

Hospital Universitario Virgen de la Arrixaca

El Palmar, Murcia, Spain

Site Status

Hospital Costa del Sol

Marbella, Málaga, Spain

Site Status

Clínica Universidad de Navarra

Pamplona, Navarre, Spain

Site Status

Hospital Lluis Alcanyis de Xátiva

Xàtiva, Valencia, Spain

Site Status

Hospital Obispo Polanco

Teruel, Zaragoza, Spain

Site Status

Hospital Infanta Cristina de Badajoz

Badajoz, , Spain

Site Status

Centre Mèdic Teknon

Barcelona, , Spain

Site Status

Hospital de la Santa Creu i Sant Pau

Barcelona, , Spain

Site Status

Hosptial de l'Esperit Sant de Barcelona

Barcelona, , Spain

Site Status

Hospital Clinic i Provincial

Barcelona, , Spain

Site Status

Hospital Plató

Barcelona, , Spain

Site Status

Hospital Universitari Sagrat Cor

Barcelona, , Spain

Site Status

Consorcio Hospitalario Provincial de Castellón

Castelló, , Spain

Site Status

Hospital San Pedro de Alcantara Cáceres

Cáceres, , Spain

Site Status

Hospital General de Ciudad Real

Ciudad Real, , Spain

Site Status

Hospital Univeritari Dr. Josep Trueta

Girona, , Spain

Site Status

Hospital Arnau de Vilanova de Lleida

Lleida, , Spain

Site Status

Hospital Universitario Fundación Jiménez Díaz

Madrid, , Spain

Site Status

Hospital La Paz

Madrid, , Spain

Site Status

Hospital Althaia

Manresa, , Spain

Site Status

Hospital Virgen de la Victoria

Málaga, , Spain

Site Status

Hospital Morales Meseguer

Murcia, , Spain

Site Status

Complejo Hospitalario Universitario de Ourense

Ourense, , Spain

Site Status

Hospital Universitari Son Llàtzer

Palma de Mallorca, , Spain

Site Status

Hospital Provincial de Pontevedra

Pontevedra, , Spain

Site Status

Hospital de Sagunto

Sagunto, , Spain

Site Status

Instituto Valenciano de Oncologia

Valencia, , Spain

Site Status

Hospital Doctor Peset

Valencia, , Spain

Site Status

Hospital Universitario y Politécnico de La Fe

Valencia, , Spain

Site Status

Complejo Hospitalario Universitario de Vigo

Vigo, , Spain

Site Status

Hospital Miguel Servet

Zaragoza, , Spain

Site Status

Countries

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Spain

Other Identifiers

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GEMCAD 1401

Identifier Type: -

Identifier Source: org_study_id

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