NCT03532711

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
264

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2012

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2016

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2016

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

May 4, 2018

Completed
18 days until next milestone

First Posted

Study publicly available on registry

May 22, 2018

Completed
Last Updated

May 22, 2018

Status Verified

May 1, 2018

Enrollment Period

4.5 years

First QC Date

May 4, 2018

Last Update Submit

May 20, 2018

Conditions

Metastatic Colorectal CancerChemotherapy EffectBiomarker

Outcome Measures

Primary Outcomes (1)

  • Objective Response Rate (ORR)

    objective response rate

    2 months

Secondary Outcomes (2)

  • Overall Survival (OS)

    6 months

  • Progression Free Survival (PFS)

    6 months

Study Arms (1)

Chemotherapy

FOLFOX/XELOX/FOLFIRI

Drug: fluorouracil

Interventions

fluorouracilDRUG

chemotherapy treated patients

Also known as: capecitabine, irinotecan hydrochloride, leucovorin calcium, oxaliplatin, laboratory biomarker analysis
Chemotherapy

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Histologically confirmed metastatic colorectal cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

FluorouracilCapecitabineIrinotecanLeucovorinOxaliplatin

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

UracilPyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesCamptothecinAlkaloidsFormyltetrahydrofolatesTetrahydrofolatesFolic AcidPterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingCoenzymesEnzymes and CoenzymesCoordination ComplexesOrganic Chemicals

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

May 4, 2018

First Posted

May 22, 2018

Study Start

January 1, 2012

Primary Completion

June 30, 2016

Study Completion

December 31, 2016

Last Updated

May 22, 2018

Record last verified: 2018-05

Data Sharing

IPD Sharing
Will not share