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Taxotere + Cisplatin in Nasopharyngeal Carcinoma

NCT ID: NCT00436293

Last Updated: 2010-11-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

61 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-12-31

Study Completion Date

2010-03-31

Brief Summary

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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

Detailed Description

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Conditions

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Nasopharyngeal Neoplasms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Neo-adjuvant Taxotere followed by cisplatin and radiotherapy

Group Type EXPERIMENTAL

Docetaxel

Intervention Type DRUG

75 mg/m²

2

Cisplatin and radiotherapy alone without neo-adjuvant chemotherapy

Group Type ACTIVE_COMPARATOR

Cisplatin

Intervention Type DRUG

75 mg/m²

Interventions

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Docetaxel

75 mg/m²

Intervention Type DRUG

Cisplatin

75 mg/m²

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sanofi

INDUSTRY

Sponsor Role lead

Responsible Party

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sanofi-aventis

Principal Investigators

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Iris Chan

Role: STUDY_DIRECTOR

Sanofi

Locations

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Sanofi-Aventis

Hong Kong, , Hong Kong

Site Status

Countries

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Hong Kong

Other Identifiers

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XRP6976F_6002

Identifier Type: -

Identifier Source: org_study_id