Clarify of Predictive Risk Factors of Chemotherapy-induced Liver Injury

NCT ID: NCT03069820

Last Updated: 2017-03-03

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-02-10
• Study Completion Date: 2018-01-01

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).

Detailed Description

Nasopharyngeal carcinoma (NPC) is one of the most common malignancies in southern China , with an annual incidence of 15 to 50 cases per 100,000 people. NPC is both radiosensitive and chemosensitive. Recently, many new drugs including docetaxel and cisplatin have been incorporated in the induction chemotherapy phase of NPC. The most common toxicity of TP (docetaxel and cisplatin) chemotherapy is chemotherapy-induced liver injury, and appropriate management of these toxicities can help patients improve tolerance for chemotherapy. However, patients don't always experience same chemotherapy-induced liver injury for the same drugs. Therefore, it is important to determine the risk factors to predict chemotherapy-induced liver injury. 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).

Conditions

Liver Injury, Drug-Induced

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

Study Population

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

Group Type: EXPERIMENTAL

docetaxel and cisplatin

Intervention Type: DRUG

Patients receive TP (docetaxel and cisplatin) chemotherapy

Interventions

docetaxel and cisplatin

Patients receive TP (docetaxel and cisplatin) chemotherapy

Intervention Type: DRUG

Other Intervention Names

Taxotere

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Second Affiliated Hospital of Nanchang University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Long Huang, MD

Role: STUDY_DIRECTOR

The Second Afiliated Hospital of Nanchang University

Locations

The Second Afiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

Site Status: RECRUITING

Countries

China

Central Contacts

Long Huang, MD

Role: CONTACT

huanglongdoctor@163.com

13699549060

Facility Contacts

Anwen Liu, MD

Role: primary

awliu666@163.com

13767120022

Other Identifiers

HL001

Identifier Type: -

Identifier Source: org_study_id