Taxotere + Cisplatin in Nasopharyngeal Carcinoma

Phase 2

Completed

• Conditions: Nasopharyngeal Neoplasms
• Interventions: Drug: Docetaxel; Drug: Cisplatin

• Registration Number: NCT00436293
• Lead Sponsor: Sanofi

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

Detailed Description

Not available

Study Timeline

• Study Start: 2002-12
• Study First Submitted: 2007-02-16
• Study First Submitted QC: 2007-02-16
• Study First Posted: 2007-02-19
• Primary Completion: 2010-03
• Study Completion: 2010-03
• Status Verified: 2010-11
• Last Update Submitted: 2010-11-16
• Last Update Posted: 2010-11-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 61

Inclusion Criteria

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Docetaxel	Neo-adjuvant Taxotere followed by cisplatin and radiotherapy
2	Cisplatin	Cisplatin and radiotherapy alone without neo-adjuvant chemotherapy

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Adverse Events	From administration of drug to end of study

Trial Locations

Locations (1)

Sanofi-Aventis; 🇭🇰 Hong Kong, Hong Kong