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Potential Predictive Biomarkers in Patients Undergoing First-line Chemotherapy for Metastatic Colorectal Cancer

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ClinicalTrials.gov Identifier: NCT03532711
Recruitment Status : Completed
First Posted : May 22, 2018
Last Update Posted : May 22, 2018
Sponsor:
Information provided by (Responsible Party):
Wen Zhang, Fudan University

Study Description
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Brief Summary:
Chemoresistance remains an obstacle in treating people with metastatic colorectal cancer (mCRC). Studying samples of blood and tumor tissue in the laboratory from patients with mCRC receiving chemotherapy may help doctors understand the effect of chemotherapy on biomarkers. It may also help doctors predict how patients will respond to treatment. In this study, we aimed to evaluate biomarkers in chemotherapy regimens for first-line chemotherapy for mCRC.

Condition or disease Intervention/treatment
Metastatic Colorectal Cancer Chemotherapy Effect Biomarker Drug: fluorouracil

Study Design
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Study Type : Observational
Actual Enrollment : 264 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: A Study to Characterize and Evaluate Biomarkers of Chemotherapy in Patients With Metastatic Colorectal Cancer In The First-line Setting
Actual Study Start Date : January 1, 2012
Actual Primary Completion Date : June 30, 2016
Actual Study Completion Date : December 31, 2016

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Chemotherapy
FOLFOX/XELOX/FOLFIRI
 Drug: fluorouracil
chemotherapy treated patients
Other Names:
  • capecitabine
  • irinotecan hydrochloride
  • leucovorin calcium
  • oxaliplatin
  • laboratory biomarker analysis


Outcome Measures
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Primary Outcome Measures :
  1. Objective Response Rate (ORR) [ Time Frame: 2 months ]
    objective response rate


Secondary Outcome Measures :
  1. Overall Survival (OS) [ Time Frame: 6 months ]
    overall survival

  2. Progression Free Survival (PFS) [ Time Frame: 6 months ]
    progression free survival


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Histologically confirmed metastatic colorectal cancer
Criteria
Inclusion Criteria Histologically confirmed metastatic colorectal cancer Unresectable metastatic disease must be confirmed histologically if > 2 years since primary diagnosis Measurable metastatic disease > 1 cm by spiral CT scan or > 2 cm by other methods Scheduled to receive first-line chemotherapy for metastatic disease Chemotherapy must include fluorouracil, capecitabine, irinotecan hydrochloride, or oxaliplatin Exclusion Criteria Inadequate or unusable tissue as the only tissue available Brain metastases or meningeal disease Contraindication to chemotherapy Pregnant or nursing Other severe pathology that is likely to worsen during therapy Dementia or severely impaired mental condition Geographical or psychological reasons that would preclude treatment
Contacts and Locations
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No Contacts or Locations Provided
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Wen Zhang, Dr, Fudan University
ClinicalTrials.gov Identifier: NCT03532711    
Other Study ID Numbers: FUSCC-BiomarkerCRC
First Posted: May 22, 2018    Key Record Dates
Last Update Posted: May 22, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Leucovorin
Fluorouracil
Capecitabine
Oxaliplatin
 Irinotecan
Levoleucovorin
Physiological Effects of Drugs
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Antidotes
Protective Agents
Vitamin B Complex