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

Sponsor
Grupo Espanol Multidisciplinario del Cancer Digestivo (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT02254941
Collaborator
(none)
1,104
Enrollment
48
Locations
100
Anticipated Duration (Months)
23
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

Study Design

Study Type:
Observational
Actual Enrollment :
1104 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Observational Study to Evaluate the Use of Targeted Therapies in Metastatic Colorectal Cancer
Actual Study Start Date :
Aug 1, 2014
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

Arm 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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Overall survival [From July 2018 (LPI), 24 months]

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

    Secondary Outcome Measures

    1. Validate prognostic score GEMCAD [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).

    2. To compare GERCOR and Köhne classification with GEMCAD classification [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).

    3. Evaluate Sadananda cellular phenotype classification [From August 2014, up to 36 months]

    4. 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 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hospital Virgen de los Lirios Alcoy Alicante Spain
    2 Hospital General Universitario de Elche Elche Alicante Spain 03203
    3 Hospital Universitario del Vinalopó Elche Alicante Spain
    4 Hospital General Universitario de Elda Elda Alicante Spain
    5 Hospital Universitario de Torrevieja Torrevieja Alicante Spain
    6 Hospital Clínico Universitario Lozano Blesa Zaragoza Aragon Spain 50009
    7 Hospital Granollers Granollers Barcelona Spain
    8 Corporació Sanitària Parc Taulí Sabadell Barcelona Spain
    9 Hospital General de Catalunya Sant Cugat del Vallès Barcelona Spain 08190
    10 Hospital de Terrasa Terrassa Barcelona Spain
    11 Hospital General de Vic Vic Barcelona Spain
    12 Hospital Universitario Virgen del Puerto de Plasencia Plasencia Cáceres Spain 10600
    13 Hospital de Donostia San Sebastián Guipúzcoa Spain 20014
    14 Centro Oncologico de Galicia A Coruña La Coruña Spain 15009
    15 Hospital Universitario de Gran Canaria Doctor Negrín Las Palmas de Gran Canaria Las Palmas Spain 35010
    16 Hospital Universitario Puerta de Hierro de Majadahonda Majadahonda Madrid Spain 28222
    17 Hospital Son Espases Palma Malllorca Spain
    18 Hospital Universitario Virgen de la Arrixaca El Palmar Murcia Spain 30120
    19 Hospital Costa del Sol Marbella Málaga Spain
    20 Clínica Universidad de Navarra Pamplona Navarra Spain 31008
    21 Hospital Lluis Alcanyis de Xátiva Xàtiva Valencia Spain
    22 Hospital Obispo Polanco Teruel Zaragoza Spain
    23 Hospital Infanta Cristina de Badajoz Badajoz Spain
    24 Centre Mèdic Teknon Barcelona Spain 08022
    25 Hospital de la Santa Creu i Sant Pau Barcelona Spain 08025
    26 Hosptial de l'Esperit Sant de Barcelona Barcelona Spain 08923
    27 Hospital Clinic i Provincial Barcelona Spain
    28 Hospital Plató Barcelona Spain
    29 Hospital Universitari Sagrat Cor Barcelona Spain
    30 Consorcio Hospitalario Provincial de Castellón Castelló Spain 12002
    31 Hospital General de Ciudad Real Ciudad Real Spain 13005
    32 Hospital San Pedro de Alcantara Cáceres Cáceres Spain 10003
    33 Hospital Univeritari Dr. Josep Trueta Girona Spain
    34 Hospital Arnau de Vilanova de Lleida Lleida Spain 25198
    35 Hospital Universitario Fundación Jiménez Díaz Madrid Spain 28040
    36 Hospital La Paz Madrid Spain
    37 Hospital Althaia Manresa Spain
    38 Hospital Morales Meseguer Murcia Spain 30008
    39 Hospital Virgen de la Victoria Málaga Spain 29010
    40 Complejo Hospitalario Universitario de Ourense Ourense Spain 32005
    41 Hospital Universitari Son Llàtzer Palma de mallorca Spain 08198
    42 Hospital Provincial de Pontevedra Pontevedra Spain 36002
    43 Hospital de Sagunto Sagunto Spain
    44 Instituto Valenciano de Oncologia Valencia Spain 46009
    45 Hospital Doctor Peset Valencia Spain 46017
    46 Hospital Universitario y Politécnico de La Fe Valencia Spain 46026
    47 Complejo Hospitalario Universitario de Vigo Vigo Spain 36036
    48 Hospital Miguel Servet Zaragoza Spain

    Sponsors and Collaborators

    • Grupo Espanol Multidisciplinario del Cancer Digestivo

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Grupo Espanol Multidisciplinario del Cancer Digestivo
    ClinicalTrials.gov Identifier:
    NCT02254941
    Other Study ID Numbers:
    • GEMCAD 1401
    First Posted:
    Oct 2, 2014
    Last Update Posted:
    Mar 16, 2022
    Last Verified:
    Mar 1, 2022
    Keywords provided by Grupo Espanol Multidisciplinario del Cancer Digestivo
    Metastatic Colon Cancer
    Monoclonal antibodies
    Chemotherapy
    First line
    Additional relevant MeSH terms:
    Colonic Neoplasms
    Antineoplastic Agents, Immunological
    Antibodies
    Immunoglobulins
    Antibodies, Monoclonal

    Study Results

    No Results Posted as of Mar 16, 2022