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

Completed

• Conditions: Chemotherapy Effect; Metastatic Colorectal Cancer; Biomarker
• Interventions: Drug: fluorouracil

• Registration Number: NCT03532711
• Lead Sponsor: Fudan University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01-01
• Primary Completion: 2016-06-30
• Study Completion: 2016-12-31
• Status Verified: 2018-05
• Study First Submitted: 2018-05-04
• Study First Submitted QC: 2018-05-20
• Last Update Submitted: 2018-05-20
• Study First Posted: 2018-05-22
• Last Update Posted: 2018-05-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 264

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Chemotherapy	fluorouracil	FOLFOX/XELOX/FOLFIRI

Primary Outcome Measures

Name	Time	Method
Objective Response Rate (ORR)	2 months	objective response rate

Secondary Outcome Measures

Name	Time	Method
Overall Survival (OS)	6 months	overall survival
Progression Free Survival (PFS)	6 months	progression free survival