NCT03177174

Brief Summary

This study was to evaluate the efficacy ,toxic reaction and safety of different chemotherapy combined with radiotherapy on patients with locally advanced nasopharyngeal carcinoma.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

March 18, 2017

Completed
3 months until next milestone

First Posted

Study publicly available on registry

June 6, 2017

Completed
6 days until next milestone

Study Start

First participant enrolled

June 12, 2017

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2020

Completed
Last Updated

February 7, 2020

Status Verified

February 1, 2020

Enrollment Period

2.6 years

First QC Date

March 18, 2017

Last Update Submit

February 6, 2020

Conditions

Drug-Related Side Effects and Adverse Reactions

Keywords

locally advanced nasopharyngeal carcinomaConcurrent chemoradiotherapyToxic reaction

Outcome Measures

Primary Outcomes (1)

  • changes in toxic reaction

    incidence rate of the toxic reaction between three groups

    5 years

Secondary Outcomes (1)

  • over survival

    5 years

Study Arms (3)

Docetaxel

ACTIVE COMPARATOR
Drug: Docetaxel

Cisplatin

ACTIVE COMPARATOR
Drug: Cisplatin

DocetaxelCisplatin

ACTIVE COMPARATOR

Cisplatin combined with Docetaxel

Drug: CisplatinDrug: Docetaxel

Interventions

CisplatinDRUG

radiotherapy combined with Chemotherapy Drugs, Cancer

CisplatinDocetaxelCisplatin
DocetaxelDRUG

Docetaxel

DocetaxelDocetaxelCisplatin

Eligibility Criteria

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

You may qualify if:

  • Patients \> 18, \<70 years old, with locally advanced nasopharyngeal carcinoma.

You may not qualify if:

  • patients who had accepted radiotherapy before patients with any ather types of cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chinese PLA general hospital

Beijing, China

Location

Related Publications (1)

  • Luo Y, Cai B, Li B, Liu F, Du L, Zhao D, Fan W, Meng L, Zhang X, Ma L. The Acute Toxicities and Efficacy of Concurrent Chemotherapy With Docetaxel Plus Cisplatin, or Docetaxel, or Cisplatin and Helical Tomotherapy in Patients With Locoregionally Advanced Nasopharyngeal Carcinoma: A Randomized Single-Center Phase II Trial. Technol Cancer Res Treat. 2022 Jan-Dec;21:15330338221109974. doi: 10.1177/15330338221109974.

    PMID: 35770295DERIVED

MeSH Terms

Conditions

Drug-Related Side Effects and Adverse Reactions

Interventions

CisplatinDocetaxel

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Chlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum CompoundsTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Clinical Doctor

Study Record Dates

First Submitted

March 18, 2017

First Posted

June 6, 2017

Study Start

June 12, 2017

Primary Completion

January 1, 2020

Study Completion

February 1, 2020

Last Updated

February 7, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)