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

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ClinicalTrials.gov Identifier: NCT02254941
Recruitment Status : Active, not recruiting
First Posted : October 2, 2014
Last Update Posted : July 23, 2020
Sponsor:
Information provided by (Responsible Party):
Grupo Espanol Multidisciplinario del Cancer Digestivo

Study Description
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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
Metastatic Colon Cancer Drug: Chemotherapy Biological: Chemotherapy plus monoclonal antibody

Study Design
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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 : August 2014
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

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Groups and Cohorts
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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 Name: 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 Name: Standard CHemotherapy plus monoclonal antibody


Outcome Measures
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Primary Outcome Measures :
  1. Overall survival [ Time Frame: 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 [ 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).


  2. 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).


  3. Evaluate Sadananda cellular phenotype classification [ Time Frame: 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 [ 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


Biospecimen Retention:   Samples With DNA
Colon biopsy

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Metastatic colorectal cancer. Adenocarcinoma. First line treatment
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02254941


Locations
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Sponsors and Collaborators
Grupo Espanol Multidisciplinario del Cancer Digestivo
Investigators
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Study Chair: Joan Maurel, MD PhD Hospital Clínic de Barcelona
More Information
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Responsible Party: Grupo Espanol Multidisciplinario del Cancer Digestivo
ClinicalTrials.gov Identifier: NCT02254941    
Other Study ID Numbers: GEMCAD 1401
First Posted: October 2, 2014    Key Record Dates
Last Update Posted: July 23, 2020
Last Verified: July 2020
Keywords provided by Grupo Espanol Multidisciplinario del Cancer Digestivo:
Metastatic Colon Cancer
Monoclonal antibodies
Chemotherapy
First line
Additional relevant MeSH terms:
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Colonic Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
 Colonic Diseases
Intestinal Diseases
Antineoplastic Agents, Immunological
Antibodies
Immunoglobulins
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents