NCT03069820

Brief Summary

The most common toxicity of TP (docetaxel and cisplatin) chemotherapy is chemotherapy-induced liver injury. However, patients don't always experience same chemotherapy-induced liver injury for the same drugs. Therefore, the investigators designed the present study to clarify risk factors associated with the development of severe hepatotoxicity after therapy with docetaxel and cisplatin for nasopharyngeal carcinoma (NPC).

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
120

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Feb 2017

Shorter than P25 for phase_4

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

February 10, 2017

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

February 13, 2017

Completed
18 days until next milestone

First Posted

Study publicly available on registry

March 3, 2017

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
Last Updated

March 3, 2017

Status Verified

February 1, 2017

Enrollment Period

11 months

First QC Date

February 13, 2017

Last Update Submit

February 27, 2017

Conditions

Liver Injury, Drug-Induced

Outcome Measures

Primary Outcomes (4)

  • Relationship of white blood cell level and chemotherapy-induced liver injury

    White blood cell level (cells/L) and liver function (such as ALT, AST, ALP, and bilirubin levels) will be tested before (1-3 days) and after (21 ± 3 days) first cycle of chemotherapy, and the relationship of white cell level fluctuation and liver injury will be investigated.

    3 weeks

  • Relationship of albumin level and chemotherapy-induced liver injury

    Albumin (g/L) and liver function (such as ALT, AST, ALP, and bilirubin levels) will be tested before (1-3 days) and after (21 ± 3 days) first cycle of chemotherapy, and the relationship of albumin fluctuation and liver injury will be investigated.

    3 weeks

  • Relationship of hemoglobin level and chemotherapy-induced liver injury

    Hemoglobin (g/L) and liver function (such as ALT, AST, ALP, and bilirubin levels) will be tested before (1-3 days) and after (21 ± 3 days) first cycle of chemotherapy, and the relationship of hemoglobin fluctuation and liver injury will be investigated.

    3 weeks

  • Relationship of blood platelet level and chemotherapy-induced liver injury

    Blood platelet (cells/L) and liver function (such as ALT, AST, ALP, and bilirubin levels) will be tested before (1-3 days) and after (21 ± 3 days) first cycle of chemotherapy, and the relationship of blood platelet fluctuation and liver injury will be investigated.

    3 weeks

Secondary Outcomes (2)

  • Relationship of age and chemotherapy-induced liver injury

    3 weeks

  • Relationship of height and chemotherapy-induced liver injury

    3 weeks

Study Arms (1)

Study Population

EXPERIMENTAL

Patients with advanced nasopharyngeal carcinoma scheduled to receive the first line, first cycle TP (docetaxel and cisplatin) chemotherapy

Drug: docetaxel and cisplatin

Interventions

docetaxel and cisplatinDRUG

Patients receive TP (docetaxel and cisplatin) chemotherapy

Also known as: Taxotere
Study Population

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with advanced nasopharyngeal carcinoma.
  • Patients scheduled to receive the first line, first cycle TP (docetaxel and cisplatin) chemotherapy.
  • Normal liver function biomarkers including ALT,AST,ALP,TBIL before recruitment.
  • Minimum age of 18 years.
  • Life expectancy at least 3 months.

You may not qualify if:

  • Patients previously received chemotherapy
  • Patients who have liver metastases.
  • Patients who take other drugs that may affect liver function

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Second Afiliated Hospital of Nanchang University

Nanchang, Jiangxi, 330006, China

RECRUITING

MeSH Terms

Conditions

Chemical and Drug Induced Liver Injury

Interventions

DocetaxelCisplatin

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesDrug-Related Side Effects and Adverse ReactionsChemically-Induced DisordersPoisoning

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesChlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum Compounds

Study Officials

  • Long Huang, MD

    The Second Afiliated Hospital of Nanchang University

    STUDY DIRECTOR

Central Study Contacts

Long Huang, MD

CONTACT

13699549060huanglongdoctor@163.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 13, 2017

First Posted

March 3, 2017

Study Start

February 10, 2017

Primary Completion

January 1, 2018

Study Completion

January 1, 2018

Last Updated

March 3, 2017

Record last verified: 2017-02

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)