NCT03030508

Brief Summary

At present, chemotherapy is widely used in the adjuvant treatment of colorectal cancer patients after surgery. Capecitabine is one of the main chemotherapeutic drugs. But the effect is not good enough, the adverse reaction is serious, and the individual differences were significant. The present study shows that these problems are related to the differences in the exposure of capecitabine and its metabolites in different patients. The genetic biomarkers for capecitabine include DRD, MTHFR and TYMS. Mutations in these genes directly affect the expression of metabolic enzymes involved in capecitabine and control the concentration of capecitabine and its metabolites. However, these markers have been obtained through clinical trials in the United States, and their role in predicting the effectiveness or safety of capecitabine and its metabolites has not been validated in Chinese cancer patients.The study was based on a case study of patients with colorectal cancer in China, and capecitabine as the primary postoperative chemotherapy regimen to verify whether the available biomarkers can be used to predict the effectiveness and safety of capecitabine. To clarify the effect of capecitabine on endogenous metabolites, and to study the mechanism of its effect, so as to discover new biomarkers.

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
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2016

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 1, 2016

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

January 13, 2017

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 25, 2017

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2019

Completed
Last Updated

January 25, 2017

Status Verified

January 1, 2017

Enrollment Period

3 years

First QC Date

January 13, 2017

Last Update Submit

January 22, 2017

Conditions

Colorectal CancerCapecitabine

Keywords

biomarkscolorectal cancercapecitabinegene polymorphism

Outcome Measures

Primary Outcomes (2)

  • Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

    Adverse Events That Are Related to Treatment

    during chemotherapy

  • Disease-free survival

    Three year disease-free survival

Secondary Outcomes (1)

  • Three year disease free survival rate

    Three year disease free survival rate

Study Arms (1)

Group cap

Patients receiving capecitabine chemotherapy after operation

Other: No intervention

Interventions

No interventionOTHER
Group cap

Eligibility Criteria

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

300 patients with colorectal cancer receiving first chemotherapy after surgery

You may qualify if:

  • more than 18 years old;
  • patients with colon cancer diagnosed by biopsy (regardless of cancer stage);
  • received postoperative containing capecitabine chemotherapy;
  • volunteer to participate in the experiment

You may not qualify if:

  • pregnant and lactating women;
  • patients with hypersensitivity to fluorouracil or severe metabolic failure;
  • patients with severe infection;
  • patients with other cancers other than colorectal cancer within the first five years of colorectal cancer surgery;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of medicine of Shanghai Changzheng Hospital

Shanghai, Shanghai Municipality, 200003, China

Location

Related Publications (11)

  • Zhang X, Sun B, Lu Z. Evaluation of clinical value of single nucleotide polymorphisms of dihydropyrimidine dehydrogenase gene to predict 5-fluorouracil toxicity in 60 colorectal cancer patients in China. Int J Med Sci. 2013 May 20;10(7):894-902. doi: 10.7150/ijms.5556. Print 2013.

    PMID: 23781135BACKGROUND

  • Li F, Qin X, Chen H, Qiu L, Guo Y, Liu H, Chen G, Song G, Wang X, Li F, Guo S, Wang B, Li Z. Lipid profiling for early diagnosis and progression of colorectal cancer using direct-infusion electrospray ionization Fourier transform ion cyclotron resonance mass spectrometry. Rapid Commun Mass Spectrom. 2013 Jan 15;27(1):24-34. doi: 10.1002/rcm.6420.

    PMID: 23239314BACKGROUND

  • Ikeda K, Oike Y, Shimizu T, Taguchi R. Global analysis of triacylglycerols including oxidized molecular species by reverse-phase high resolution LC/ESI-QTOF MS/MS. J Chromatogr B Analyt Technol Biomed Life Sci. 2009 Sep 1;877(25):2639-47. doi: 10.1016/j.jchromb.2009.03.047. Epub 2009 Apr 7.

    PMID: 19481987BACKGROUND

  • Denkert C, Bucher E, Hilvo M, Salek R, Oresic M, Griffin J, Brockmoller S, Klauschen F, Loibl S, Barupal DK, Budczies J, Iljin K, Nekljudova V, Fiehn O. Metabolomics of human breast cancer: new approaches for tumor typing and biomarker discovery. Genome Med. 2012 Apr 30;4(4):37. doi: 10.1186/gm336.

    PMID: 22546809BACKGROUND

  • Wu CW, Ng SS, Dong YJ, Ng SC, Leung WW, Lee CW, Wong YN, Chan FK, Yu J, Sung JJ. Detection of miR-92a and miR-21 in stool samples as potential screening biomarkers for colorectal cancer and polyps. Gut. 2012 May;61(5):739-45. doi: 10.1136/gut.2011.239236. Epub 2011 Sep 19.

    PMID: 21930727BACKGROUND

  • Deenen MJ, Meulendijks D, Cats A, Sechterberger MK, Severens JL, Boot H, Smits PH, Rosing H, Mandigers CM, Soesan M, Beijnen JH, Schellens JH. Upfront Genotyping of DPYD*2A to Individualize Fluoropyrimidine Therapy: A Safety and Cost Analysis. J Clin Oncol. 2016 Jan 20;34(3):227-34. doi: 10.1200/JCO.2015.63.1325. Epub 2015 Nov 16.

    PMID: 26573078BACKGROUND

  • Huang L, Chen F, Chen Y, Yang X, Xu S, Ge S, Fu S, Chao T, Yu Q, Liao X, Hu G, Zhang P, Yuan X. Thymidine phosphorylase gene variant, platelet counts and survival in gastrointestinal cancer patients treated by fluoropyrimidines. Sci Rep. 2014 Jul 16;4:5697. doi: 10.1038/srep05697.

    PMID: 25027354BACKGROUND

  • Li M, Yan T, Chen J, Wang Z, Gao S, Deng Y, Qiu S, Liu X, Huang L, Hou X, Tao X, Yang M, Chen W. Plasma endogenous metabolome as superior biomarkers for adverse effects compared to drug and its metabolites. Future Oncol. 2026 Jan;22(2):167-180. doi: 10.1080/14796694.2025.2609305. Epub 2025 Dec 30.

    PMID: 41468321DERIVED

  • Xu J, Lin Z, Chen J, Zhang J, Li W, Zhang R, Xing J, Ye Z, Liu X, Gao Q, Chen X, Zhai J, Yao H, Li M, Wei H. Milk and Egg Are Risk Factors for Adverse Effects of Capecitabine-Based Chemotherapy in Chinese Colorectal Cancer Patients. Integr Cancer Ther. 2022 Jan-Dec;21:15347354221105485. doi: 10.1177/15347354221105485.

    PMID: 35686441DERIVED

  • Li M, Sun X, Yao H, Chen W, Zhang F, Gao S, Zou X, Chen J, Qiu S, Wei H, Hu Z, Chen W. Genomic methylation variations predict the susceptibility of six chemotherapy related adverse effects and cancer development for Chinese colorectal cancer patients. Toxicol Appl Pharmacol. 2021 Sep 15;427:115657. doi: 10.1016/j.taap.2021.115657. Epub 2021 Jul 29.

    PMID: 34332992DERIVED

  • Li M, Chen J, Deng Y, Yan T, Gu H, Zhou Y, Yao H, Wei H, Chen W. Risk prediction models based on hematological/body parameters for chemotherapy-induced adverse effects in Chinese colorectal cancer patients. Support Care Cancer. 2021 Dec;29(12):7931-7947. doi: 10.1007/s00520-021-06337-z. Epub 2021 Jul 2.

    PMID: 34213641DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

tissue,blood,urine and stool sample

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

  • Wansheng Chen, PhD

    Department of medicine of Shanghai Changzheng Hospital

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Director of Department of Pharmacy

Study Record Dates

First Submitted

January 13, 2017

First Posted

January 25, 2017

Study Start

January 1, 2016

Primary Completion

January 1, 2019

Study Completion

March 1, 2019

Last Updated

January 25, 2017

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)