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NCT03532711 Clinical Trial

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

Metastatic Colorectal Cancer Clinical Trial

Official title:
A Study to Characterize and Evaluate Biomarkers of Chemotherapy in Patients With Metastatic Colorectal Cancer In The First-line Setting

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03532711
Other study ID # FUSCC-BiomarkerCRC
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2012
Est. completion date December 31, 2016

Study information
Verified date May 2018
Source Fudan University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 264
Est. completion date December 31, 2016
Est. primary completion date June 30, 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• fluorouracil
chemotherapy treated patients

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Fudan University

Outcome
Type Measure Description Time frame Safety issue
Primary Objective Response Rate (ORR) objective response rate 2 months
Secondary Overall Survival (OS) overall survival 6 months
Secondary Progression Free Survival (PFS) progression free survival 6 months
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