NCT00539630

Brief Summary

To describe the clinical response rate in two groups (Docetaxel plus cisplatin plus 5-FU, versus Cisplatin plus 5-FU) after 3 cycle of neoadjuvant chemotherapy.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
86

participants targeted

Target at below P25 for phase_3

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

November 1, 2002

Completed
4.9 years until next milestone

First Submitted

Initial submission to the registry

October 3, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 4, 2007

Completed
Last Updated

October 4, 2007

Status Verified

October 1, 2007

First QC Date

October 3, 2007

Last Update Submit

October 3, 2007

Conditions

Carcinoma, Squamous Cell

Outcome Measures

Primary Outcomes (1)

  • Clinical response will be evaluated by modified WHO criteria. Clinical and radiological assessment of all lesions will be performed

    After 2 cycle, 3 cycle and after concurrent chemo/radiotherapy.

Secondary Outcomes (1)

  • Pathologic response if clinical response of primary tumor is CR at the end of chemotherapy and end of concurrent chemo/ radiotherapy, biopsy of primary tumor site will be performed to evaluate pathologic response rate.

Interventions

DocetaxelDRUG

Eligibility Criteria

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

You may qualify if:

  • Histologically or cytologically proven squamous cell carcinoma of the head and neck with locally advanced inoperable disease.
  • Primary tumor sites eligible: oral cavity, oropharynx, hypopharynx , larynx or nasopharynx.
  • Patients are required to have at least one (bi-or uni-dimensionally) measurable lesion.
  • WHO performance status 0 or 1.
  • Adequate bone marrow, hepatic and renal functions.

You may not qualify if:

  • Pregnant and lactating women
  • Previous chemotherapy
  • Previous radiotherapy for H\&N
  • Previous surgery for H\&N
  • 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

Seoul, South Korea

Location

MeSH Terms

Conditions

Carcinoma, Squamous Cell

Interventions

Docetaxel

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNeoplasms, Squamous Cell

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenes

Study Officials

  • Hyang Rim Kim

    Sanofi

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 3, 2007

First Posted

October 4, 2007

Study Start

November 1, 2002

Last Updated

October 4, 2007

Record last verified: 2007-10

Locations

KR(1)