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

Conditions
Metastatic Colon Cancer
Interventions
Biological: Chemotherapy plus monoclonal antibody
Drug: 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
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 & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
Experimental: Chemotherapy plus mAbChemotherapy plus monoclonal antibodyMetastatic colon cancer and first line treatment with conventional chemotherapy plus monoclonal antibody
Active comparator: ChemotherapyChemotherapyMetastatic colon cancer and first line treatment with conventional chemotherapy without monoclonal antibody.
Primary Outcome Measures
NameTimeMethod
Overall survivalFrom July 2018 (LPI), 24 months

From date of inclusion until the date of death from any cause.

Secondary Outcome Measures
NameTimeMethod
Evaluate Sadananda cellular phenotype classificationFrom August 2014, up to 36 months
Validate prognostic score GEMCADFrom 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 classificationFrom 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 chemotherapyFrom 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

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