NCT00436293

Brief Summary

Primary objective: To assess and compare the toxicities of patients with advanced NPC treated with concurrent cisplatin-radiotherapy with or without neoadjuvant Taxotere (docetaxel) and cisplatin. Secondary objective: To assess tumor control and survival

Trial Health

87
On Track

Trial Health Score

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

Enrollment
61

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Dec 2002

Longer than P75 for phase_2

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

Study Start

First participant enrolled

December 1, 2002

Completed
4.2 years until next milestone

First Submitted

Initial submission to the registry

February 16, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 19, 2007

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
Last Updated

November 17, 2010

Status Verified

November 1, 2010

Enrollment Period

7.3 years

First QC Date

February 16, 2007

Last Update Submit

November 16, 2010

Conditions

Nasopharyngeal Neoplasms

Outcome Measures

Primary Outcomes (1)

  • Treatment response is evaluated by correlating findings on clinical examination, endoscopy, biopsy, Computed tomography or Magnetic resonance imaging as appropriate.

    From administration of drug to end of study

Secondary Outcomes (1)

  • Adverse Events

    From administration of drug to end of study

Study Arms (2)

1

EXPERIMENTAL

Neo-adjuvant Taxotere followed by cisplatin and radiotherapy

Drug: Docetaxel

2

ACTIVE COMPARATOR

Cisplatin and radiotherapy alone without neo-adjuvant chemotherapy

Drug: Cisplatin

Interventions

DocetaxelDRUG

75 mg/m²

1
CisplatinDRUG

75 mg/m²

2

Eligibility Criteria

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

You may qualify if:

  • International Union against Cancer stages III and IV newly diagnosed NPC

You may not qualify if:

  • Inadequate bone marrow reserve
  • Inadequate renal function
  • Other primary malignancy
  • Evidence of distant metastases
  • The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sanofi-Aventis

Hong Kong, Hong Kong

Location

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

Study Officials

  • Iris Chan

    Sanofi

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

February 16, 2007

First Posted

February 19, 2007

Study Start

December 1, 2002

Primary Completion

March 1, 2010

Study Completion

March 1, 2010

Last Updated

November 17, 2010

Record last verified: 2010-11

Locations

HK(1)