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OpenTrials
Completed

NCT Number: NCT00436293

Taxotere + Cisplatin in Nasopharyngeal Carcinoma

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

Completed

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Key information

Conditions

Nasopharyngeal Neoplasms Head and Neck Neoplasms Nasopharyngeal Diseases Neoplasms Neoplasms by Site Otorhinolaryngologic Diseases Otorhinolaryngologic Neoplasms Pharyngeal Diseases Pharyngeal Neoplasms Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Sanofi-Aventis

Hong Kong

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

docetaxel

Drug

75 mg/m²

Cisplatin

Drug

75 mg/m²

Primary outcomes

  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 outcomes

  1. Adverse Events

    Time frame: From administration of drug to end of study

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study title

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

Important dates

Study start
2002
Primary completion
2010
Study completion
2010
First posted
Feb 19, 2007
Registry last updated
Nov 17, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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