NCT00563927

Brief Summary

To test the therapeutic ratio of additional chemotheray on advanced nasopharyngeal carcinoma.

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
340

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 1999

Longer than P75 for not_applicable

Geographic Reach
1 country

4 active sites

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

March 1, 1999

Completed
8.7 years until next milestone

First Submitted

Initial submission to the registry

November 21, 2007

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 26, 2007

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed
Last Updated

July 7, 2010

Status Verified

July 1, 2010

First QC Date

November 21, 2007

Last Update Submit

July 6, 2010

Conditions

Nasopharyngeal NeoplasmsCarcinoma, Squamous Cell

Keywords

Nasopharyngeal CarcinomaT1-4N2-3M0

Outcome Measures

Primary Outcomes (1)

  • Failure free survival rate

    5 year

Secondary Outcomes (3)

  • Disease-specific survival rate

    5-year

  • Overall survival rate

    5-year

  • Complication-free rates

    5-year

Interventions

Conventional RTPROCEDURE
CisplatinDRUG
5-fluorouracilDRUG

Eligibility Criteria

AgeUp to 70 Years
Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Undifferentiated or non-keratinizing carcinoma
  • Tumor staged as N2-3
  • No evidence of distant metastasis M0
  • Performance status:0-2
  • Marrow: WBC \>= 4 and platelet \>= 100
  • Renal: creatinine clearance \>= 60
  • Informed consent

You may not qualify if:

  • WHO type I squamous cell carcinoma or adenocarcinoma
  • Age \>= 70
  • Palliative intent or tumor extent mandating AP opposing facio-cervical fields
  • Prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease-free for 5 years
  • Previous radiotherapy (except non-melanomatous skin cancers outside the intended RT treatment volume
  • Previous chemotherapy
  • Patient is pregnant or lactating

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Pamela Youde Nethersole Eastern Hospital

Hong Kong, China

Location

Queen Elizabeth Hospital

Hong Kong, China

Location

Queen Mary Hospital

Hong Kong, China

Location

Tuen Mun Hospital

Hong Kong, China

Location

MeSH Terms

Conditions

Nasopharyngeal NeoplasmsCarcinoma, Squamous CellNasopharyngeal Carcinoma

Interventions

CisplatinFluorouracil

Condition Hierarchy (Ancestors)

Pharyngeal NeoplasmsOtorhinolaryngologic NeoplasmsHead and Neck NeoplasmsNeoplasms by SiteNeoplasmsNasopharyngeal DiseasesPharyngeal DiseasesStomatognathic DiseasesOtorhinolaryngologic DiseasesCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasms, Squamous Cell

Intervention Hierarchy (Ancestors)

Chlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum CompoundsUracilPyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Wai Hon LAU, Dr

    Department of Clinical Oncology, Queen Elizabeth Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

November 21, 2007

First Posted

November 26, 2007

Study Start

March 1, 1999

Study Completion

October 1, 2009

Last Updated

July 7, 2010

Record last verified: 2010-07

Locations

CN(4)