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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

Tracking Information
First Submitted Date September 23, 2014
First Posted Date October 2, 2014
Last Update Posted Date July 23, 2020
Actual Study Start Date August 2014
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 26, 2018)
Overall survival [ Time Frame: From July 2018 (LPI), 24 months ]
From date of inclusion until the date of death from any cause.
Original Primary Outcome Measures
 (submitted: September 29, 2014)
Overall survival [ Time Frame: Date randomization-date death ]
From date of randomization until the date of death from any cause.
Change History
Current Secondary Outcome Measures
 (submitted: September 29, 2014)
  • 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).
  • 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).
  • Evaluate Sadananda cellular phenotype classification [ Time Frame: 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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Observational Study to Evaluate the Use of Targeted Therapies in Metastatic Colorectal Cancer
Official Title Observational Study to Evaluate the Use of Targeted Therapies in Metastatic Colorectal Cancer
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 Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Colon biopsy
Sampling Method Non-Probability Sample
Study Population Metastatic colorectal cancer. Adenocarcinoma. First line treatment
Condition Metastatic Colon Cancer
Intervention
  • Drug: Chemotherapy
    Metastatic colon cancer, first line treatment with conventional chemotherapy
    Other Name: Standard Chemotherapy
  • Biological: Chemotherapy plus monoclonal antibody
    Metastatic colon cancer, first line treatment with conventional chemotherapy plus monoclonal antibody
    Other Name: Standard CHemotherapy plus monoclonal antibody
Study Groups/Cohorts
  • Active comparator: Chemotherapy
    Metastatic colon cancer and first line treatment with conventional chemotherapy without monoclonal antibody.
    Intervention: Drug: Chemotherapy
  • Experimental: Chemotherapy plus mAb
    Metastatic colon cancer and first line treatment with conventional chemotherapy plus monoclonal antibody
    Intervention: Biological: Chemotherapy plus monoclonal antibody
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Actual Enrollment
 (submitted: July 24, 2018)
1104
Original Estimated Enrollment
 (submitted: September 29, 2014)
1950
Estimated Study Completion Date December 2020
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Spain
Removed Location Countries  
 
Administrative Information
NCT Number NCT02254941
Other Study ID Numbers GEMCAD 1401
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Grupo Espanol Multidisciplinario del Cancer Digestivo
Study Sponsor Grupo Espanol Multidisciplinario del Cancer Digestivo
Collaborators Not Provided
Investigators
Study Chair: Joan Maurel, MD PhD Hospital Clínic de Barcelona
PRS Account Grupo Espanol Multidisciplinario del Cancer Digestivo
Verification Date July 2020