Taxotere + Cisplatin in Nasopharyngeal Carcinoma

Nasopharyngeal Neoplasms Clinical Trial

Official title:

A Randomized Phase II Study of Concurrent Cisplatin-radiotherapy With or Without Neoadjuvant Chemotherapy Using Taxotere and Cisplatin in Advanced Nasopharyngeal Carcinoma (NPC)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00436293
• Other study ID #: XRP6976F_6002
• Status: Completed
• Phase: Phase 2
• First received: February 16, 2007
• Last updated: November 16, 2010
• Start date: December 2002
• Est. completion date: March 2010

Study information

• Verified date: November 2010
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hong Kong: Department of Health
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: March 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Nasopharyngeal Neoplasms

Intervention

Drug:
• Docetaxel
75 mg/m²
• Cisplatin
75 mg/m²

Locations

Country	Name	City	State
Hong Kong	Sanofi-Aventis	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Adverse Events		From administration of drug to end of study	Yes