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

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.

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Key information

Conditions

Metastatic Colorectal Cancer Biomarker Chemotherapy Effect Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fluorouracil

Drug

chemotherapy treated patients

Other names: capecitabine, irinotecan hydrochloride, leucovorin calcium, oxaliplatin, laboratory biomarker analysis

Primary outcomes

Objective Response Rate (ORR)

Time frame: 2 months

objective response rate

Secondary outcomes

Overall Survival (OS)

Time frame: 6 months

overall survival
Progression Free Survival (PFS)

Time frame: 6 months

progression free survival

Sponsors and collaborators

Lead sponsor

Fudan University

Other

Registry information

Official study title

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

Important dates

Study start: 2012
Primary completion: 2016
Study completion: 2016
First posted: May 22, 2018
Registry last updated: May 22, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed