NCT00577057

Brief Summary

The objectives of this clinical study are threefold:

  1. 1.To compare the benefits in cancer control and survival obtained from adding induction-concurrent chemotherapy to radiation with those from adding concurrent-adjuvant chemotherapy to radiation.
  2. 2.To test whether replacing fluorouracil with Xeloda in combining with cisplatin (PF or PX, respectively) in the chemotherapy plan will maintain or improve further the chemotherapy benefits while reducing the duration of hospital stay.
  3. 3.To see if accelerated fractionation radiotherapy can improve the outcome of patients as compared with conventional fractionation radiotherapy.

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
798

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2006

Longer than P75 for not_applicable

Geographic Reach
1 country

6 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

September 1, 2006

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

December 18, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 19, 2007

Completed
5.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
Last Updated

August 22, 2013

Status Verified

August 1, 2013

First QC Date

December 18, 2007

Last Update Submit

August 21, 2013

Conditions

Nasopharyngeal Neoplasms

Keywords

Nasopharyngeal CarcinomaStage III - IVB

Outcome Measures

Primary Outcomes (2)

  • Progression-free survival

    5-year

  • Overall Survival

    5-year

Secondary Outcomes (3)

  • Overall / Locoregional / Distant Failure Free Rate

    5-year

  • Chemotherapy and RT toxicity

    within 90 day from commencement of RT

  • Late Toxicity

    5-year

Interventions

Conventional RadiotherapyPROCEDURE
Accelerated RadiotherapyPROCEDURE
CisplatinDRUG
5-fluorouracilDRUG
CapecitabineDRUG

Eligibility Criteria

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

You may qualify if:

  • Histologically proven nasopharyngeal carcinoma
  • Non-keratinizing or undifferentiated type Stage III-IVB (by AJCC/UICC 6th edition)
  • Essential staging investigations: CT or MRI of nasopharyngeal region Chest x-ray (or CT thorax)
  • Liver function test, alkaline phosphatase Liver and bone scan if alkaline phosphatase exceeds the institutional upper limit of normal, or if clinically indicated.
  • Liver scan if SGOT exceeds the institutional upper limit of normal
  • Adequate marrow: WBC \> 4 and platelet \> 100
  • Adequate renal function: creatinine clearance \> 60 ml/min.
  • Satisfactory performance status: \> 2 by ECOG System.

You may not qualify if:

  • WHO Type I squamous cell carcinoma or adenocarcinoma
  • Age \> 70
  • Treatment with palliative intent (including those with tumor extent mandating the use of AP opposing facio-cervical field technique)
  • 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 five years.
  • Pregnancy or lactation (consider pregnancy test in women of child-bearing age and emphasize effective contraception during the treatment period).
  • History of previous RT (except for non-melanomatous skin cancers outside intended RT treatment volume).
  • Prior chemotherapy or surgery (except diagnostic) to primary tumor or nodes.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Pamela Youde Nethersole Eastern Hospital

Hong Kong, China

Location

Prince of Wales Hospital

Hong Kong, China

Location

Princess Margaret 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 NeoplasmsNasopharyngeal Carcinoma

Interventions

CisplatinFluorouracilCapecitabine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Chlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum CompoundsUracilPyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and Nucleosides

Study Officials

  • Anne WM Lee, Cos

    Clinical Oncology, Pamela Youde Nethersole Eastern Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Anne WM Lee, Cos

CONTACT

(852) 2595 4173awmlee@ha.org.hk

Study Design

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

Study Record Dates

First Submitted

December 18, 2007

First Posted

December 19, 2007

Study Start

September 1, 2006

Study Completion

August 1, 2013

Last Updated

August 22, 2013

Record last verified: 2013-08

Locations

CN(6)