NCT01312311

Brief Summary

The investigators will evaluate weekly docetaxel plus 3-weekly cisplatin regimen as the first-line therapy for recurrent of metastatic nasophayngeal cancer

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
51

participants targeted

Target at P25-P50 for phase_2

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

July 1, 2006

Completed
4.6 years until next milestone

First Submitted

Initial submission to the registry

February 21, 2011

Completed
17 days until next milestone

First Posted

Study publicly available on registry

March 10, 2011

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
Last Updated

March 10, 2011

Status Verified

March 1, 2011

Enrollment Period

4.8 years

First QC Date

February 21, 2011

Last Update Submit

March 8, 2011

Conditions

Nasopharyngeal Cancer

Keywords

nasopharyngeal cancerweekly docetaxelcisplatin

Outcome Measures

Primary Outcomes (1)

  • objective response rate

    6 months after the enrollment of the last patients

Secondary Outcomes (1)

  • number of patients with adverse events

    simultaneously when the analysis of primary endpoint

Study Arms (1)

weekly docetaxel and cisplatin

EXPERIMENTAL

Docetaxel 35mg/m2 D1 \& D8 Cisplatin 70mg/m2 D1 every 3 weeks maxinum 6 cycles

Drug: Docetaxel, Cisplatin

Interventions

Docetaxel, CisplatinDRUG

Docetaxel 35mg/m2 D1 \& D8 Cisplatin 70mg/m2 D1

weekly docetaxel and cisplatin

Eligibility Criteria

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

You may qualify if:

  • histologically confirmed nasopharyngeal cancer
  • chemotherapy or radiotherapy naive (but, including patients completed 6 months before the enrollment)
  • ECOG 0-1
  • at least one measurable lesion

You may not qualify if:

  • other cancer
  • pregnat
  • docetaxel hypersentitivity history
  • severe heart or pulmonary disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Center

Seoul, 135-710, South Korea

RECRUITING

MeSH Terms

Conditions

Nasopharyngeal Neoplasms

Interventions

DocetaxelCisplatin

Condition Hierarchy (Ancestors)

Pharyngeal NeoplasmsOtorhinolaryngologic NeoplasmsHead and Neck NeoplasmsNeoplasms by SiteNeoplasmsNasopharyngeal DiseasesPharyngeal DiseasesStomatognathic DiseasesOtorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesChlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum Compounds

Central Study Contacts

Myung-Ju Ahn, Pf

CONTACT

82-2-3410-3459silkahn@skku.edu

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 21, 2011

First Posted

March 10, 2011

Study Start

July 1, 2006

Primary Completion

May 1, 2011

Last Updated

March 10, 2011

Record last verified: 2011-03

Locations

KR(1)