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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03532711
Enrollment
264
Registered
2018-05-22
Start date
2012-01-01
Completion date
2016-12-31
Last updated
2018-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Biomarker, Chemotherapy Effect, Metastatic Colorectal Cancer

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.

Interventions

DRUGfluorouracil

chemotherapy treated patients

Sponsors

Fudan University
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Objective Response Rate (ORR)2 monthsobjective response rate

Secondary

MeasureTime frameDescription
Overall Survival (OS)6 monthsoverall survival
Progression Free Survival (PFS)6 monthsprogression free survival

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 4, 2026