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Taxotere + Cisplatin in Nasopharyngeal Carcinoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00436293
Recruitment Status : Completed
First Posted : February 19, 2007
Last Update Posted : November 17, 2010
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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

Condition or disease Intervention/treatment Phase
Nasopharyngeal Neoplasms Drug: Docetaxel Drug: Cisplatin Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 61 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Study Start Date : December 2002
Actual Primary Completion Date : March 2010
Actual Study Completion Date : March 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 1
Neo-adjuvant Taxotere followed by cisplatin and radiotherapy
Drug: Docetaxel
75 mg/m²

Active Comparator: 2
Cisplatin and radiotherapy alone without neo-adjuvant chemotherapy
Drug: Cisplatin
75 mg/m²

Primary Outcome Measures :
  1. Treatment response is evaluated by correlating findings on clinical examination, endoscopy, biopsy, Computed tomography or Magnetic resonance imaging as appropriate. [ Time Frame: From administration of drug to end of study ]

Secondary Outcome Measures :
  1. Adverse Events [ Time Frame: From administration of drug to end of study ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00436293

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Hong Kong
Hong Kong, Hong Kong
Sponsors and Collaborators
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Study Director: Iris Chan Sanofi

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Responsible Party: Trial Transparency Team, sanofi-aventis Identifier: NCT00436293     History of Changes
Other Study ID Numbers: XRP6976F_6002
First Posted: February 19, 2007    Key Record Dates
Last Update Posted: November 17, 2010
Last Verified: November 2010

Additional relevant MeSH terms:
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Nasopharyngeal Carcinoma
Nasopharyngeal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Nasopharyngeal Diseases
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action