NCT03852290

Brief Summary

Fluoropyrimidines are the backbone of chemotherapy regimes used to treat metastatic colorectal cancer (CRC). These drugs act in different pathways of folate metabolism altering DNA synthesis mainly by inhibition of the tymidylate synthase. For this reaction the 5,10-methylenetetrahydrofolate acts as cofactor. It has been demonstrated that A1298C and C677T polymorphisms in the methylenetetrahydrofolate reductase (MTHFR) gene result in reduced enzyme activity that leads to reduced availability of this important cofactor. Hence, we hypothesized that the presence of these polymorphisms are related to the efficacy and toxicity of fluoropyrimidines in patients with CRC.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
65

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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 16, 2019

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 19, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 25, 2019

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2021

Completed
Last Updated

March 26, 2020

Status Verified

March 1, 2020

Enrollment Period

2.7 years

First QC Date

February 19, 2019

Last Update Submit

March 25, 2020

Conditions

Colon CancerMTHFR Gene MutationChemotherapeutic ToxicityChemotherapy Effect

Keywords

Colon cancerFluoropyrimidine

Outcome Measures

Primary Outcomes (3)

  • Assessment of C677T and A1298C MTHFR polymorphisms and overall survival

    Overall survival

    From the start date of treatment until the date of death from any cause, assessed up to 24 months

  • Assessment of C677T and A1298C MTHFR polymorphisms and progression-free survival

    Progression-Free survival

    From the start date of treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months

  • Assessment of C677T and A1298C MTHFR polymorphisms and response rate

    Response rate

    From the start date of treatment until the first radiological or clinical assessment, up to 6 months.

Secondary Outcomes (1)

  • Assessment of C677T and A1298 MTHFR polymorphisms and toxicity

    From treatment initiation to detected toxicity during treatment with any fluoropyrimidine alone or in combination with oxaliplatin, irinotecan or any biological treatment as first line therapy of colorectal metastatic cancer (up to 24 months)

Eligibility Criteria

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

50 patients with metastatic colorectal cancer treated with any fluoropyrimidine.

You may qualify if:

  • Patients with metastatic colorectal cancer receiving first line therapy with any fluoropyrimidine (capecitabine or 5-Fluorouracil) alone or in association with oxaliplatin, and/or irinotecan, plus either bevacizumab or cetuximab/panitumumab.

You may not qualify if:

  • Any other malignant condition

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital San Juan de Dios

San José, 1000, Costa Rica

Location

Related Publications (1)

  • Ramos-Esquivel A, Chinchilla-Monge R, Abbas J, Valle M. C677T and A1298C MTHFR gene polymorphisms and response to fluoropyrimidine-based chemotherapy in Mestizo patients with metastatic colorectal cancer. Pharmacogenet Genomics. 2021 Dec 1;31(9):191-199. doi: 10.1097/FPC.0000000000000440.

    PMID: 34116533DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

DNA extracted from blood samples and tumor tissue.

MeSH Terms

Conditions

Colonic Neoplasms

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal Diseases

Study Officials

  • Allan Ramos-Esquivel, Mic

    Universidad de Costa Rica

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 19, 2019

First Posted

February 25, 2019

Study Start

January 16, 2019

Primary Completion

October 1, 2021

Study Completion

October 1, 2021

Last Updated

March 26, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations

CO(1)