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

March 15, 2022 updated by: Grupo Espanol Multidisciplinario del Cancer Digestivo
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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

1104

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Badajoz, Spain
        • Hospital Infanta Cristina de Badajoz
      • Barcelona, Spain, 08025
        • Hospital de la Santa Creu i Sant Pau
      • Barcelona, Spain
        • Hospital Clinic I Provincial
      • Barcelona, Spain
        • Hospital Universitari Sagrat Cor
      • Barcelona, Spain, 08022
        • Centre Mèdic Teknon
      • Barcelona, Spain, 08923
        • Hosptial de l'Esperit Sant de Barcelona
      • Barcelona, Spain
        • Hospital Plató
      • Castelló, Spain, 12002
        • Consorcio Hospitalario Provincial de Castellon
      • Ciudad Real, Spain, 13005
        • Hospital General de Ciudad Real
      • Cáceres, Spain, 10003
        • Hospital San Pedro de Alcantara Cáceres
      • Girona, Spain
        • Hospital Univeritari Dr. Josep Trueta
      • Lleida, Spain, 25198
        • Hospital Arnau de Vilanova de Lleida
      • Madrid, Spain, 28040
        • Hospital Universitario Fundacion Jimenez Diaz
      • Madrid, Spain
        • Hospital La Paz
      • Manresa, Spain
        • Hospital Althaia
      • Murcia, Spain, 30008
        • Hospital Morales Meseguer
      • Málaga, Spain, 29010
        • Hospital Virgen de la Victoria
      • Ourense, Spain, 32005
        • Complejo Hospitalario Universitario de Ourense
      • Palma de mallorca, Spain, 08198
        • Hospital universitari Son LLatzer
      • Pontevedra, Spain, 36002
        • Hospital Provincial de Pontevedra
      • Sagunto, Spain
        • Hospital de Sagunto
      • Valencia, Spain, 46009
        • Instituto Valenciano de Oncología
      • Valencia, Spain, 46017
        • Hospital Doctor Peset
      • Valencia, Spain, 46026
        • Hospital Universitario y Politécnico de La Fe
      • Vigo, Spain, 36036
        • Complejo Hospitalario Universitario de Vigo
      • Zaragoza, Spain
        • Hospital Miguel Servet
    • Alicante
      • Alcoy, Alicante, Spain
        • Hospital Virgen de los Lirios
      • Elche, Alicante, Spain, 03203
        • Hospital General Universitario de Elche
      • Elche, Alicante, Spain
        • Hospital Universitario del Vinalopó
      • Elda, Alicante, Spain
        • Hospital General Universitario de Elda
      • Torrevieja, Alicante, Spain
        • Hospital Universitario de Torrevieja
    • Aragon
      • Zaragoza, Aragon, Spain, 50009
        • Hospital Clínico Universitario Lozano Blesa
    • Barcelona
      • Granollers, Barcelona, Spain
        • Hospital Granollers
      • Sabadell, Barcelona, Spain
        • Corporacio Sanitaria Parc Tauli
      • Sant Cugat del Vallès, Barcelona, Spain, 08190
        • Hospital General de Catalunya
      • Terrassa, Barcelona, Spain
        • Hospital de Terrasa
      • Vic, Barcelona, Spain
        • Hospital General de Vic
    • Cáceres
      • Plasencia, Cáceres, Spain, 10600
        • Hospital Universitario Virgen del Puerto de Plasencia
    • Guipúzcoa
      • San Sebastián, Guipúzcoa, Spain, 20014
        • Hospital de Donostia
    • La Coruña
      • A Coruña, La Coruña, Spain, 15009
        • Centro Oncológico de Galicia
    • Las Palmas
      • Las Palmas de Gran Canaria, Las Palmas, Spain, 35010
        • Hospital Universitario de Gran Canaria Doctor Negrin
    • Madrid
      • Majadahonda, Madrid, Spain, 28222
        • Hospital Universitario Puerta de Hierro de Majadahonda
    • Malllorca
      • Palma, Malllorca, Spain
        • Hospital Son Espases
    • Murcia
      • El Palmar, Murcia, Spain, 30120
        • Hospital Universitario Virgen de la Arrixaca
    • Málaga
      • Marbella, Málaga, Spain
        • Hospital Costa del Sol
    • Navarra
      • Pamplona, Navarra, Spain, 31008
        • Clinica Universidad de Navarra
    • Valencia
      • Xàtiva, Valencia, Spain
        • Hospital Lluís Alcanyís de Xàtiva
    • Zaragoza
      • Teruel, Zaragoza, Spain
        • Hospital Obispo Polanco

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Metastatic colorectal cancer. Adenocarcinoma. First line treatment

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Active comparator: Chemotherapy
Metastatic colon cancer and first line treatment with conventional chemotherapy without monoclonal antibody.
Drug: Chemotherapy
Metastatic colon cancer, first line treatment with conventional chemotherapy
Other Names:
  • Standard Chemotherapy
Experimental: Chemotherapy plus mAb
Metastatic colon cancer and first line treatment with conventional chemotherapy plus monoclonal antibody
Biological: Chemotherapy plus monoclonal antibody
Metastatic colon cancer, first line treatment with conventional chemotherapy plus monoclonal antibody
Other Names:
  • Standard CHemotherapy plus monoclonal antibody

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: From July 2018 (LPI), 24 months
From date of inclusion until the date of death from any cause.
From July 2018 (LPI), 24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Validate prognostic score GEMCAD
Time Frame: 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).
From August 2014, up to 36 months
To compare GERCOR and Köhne classification with GEMCAD classification
Time Frame: 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).
From August 2014, up to 36 months
Evaluate Sadananda cellular phenotype classification
Time Frame: From August 2014, up to 36 months
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
Time Frame: 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
From August 2014, up to 36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Grupo Espanol Multidisciplinario del Cancer Digestivo

Investigators

  • Study Chair: Joan Maurel, MD PhD, Hospital Clinic of Barcelona

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2014

Primary Completion (Anticipated)

December 1, 2022

Study Completion (Anticipated)

December 1, 2022

Study Registration Dates

First Submitted

September 23, 2014

First Submitted That Met QC Criteria

September 29, 2014

First Posted (Estimate)

October 2, 2014

Study Record Updates

Last Update Posted (Actual)

March 16, 2022

Last Update Submitted That Met QC Criteria

March 15, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GEMCAD 1401

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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