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Efficacy of Chemoradiotherapy After Neoadjuvant Cisplatin and Docetaxel in the Nasopharynx Carcinoma (Tax-Nazo)

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: NCT00772681
Recruitment Status : Completed
First Posted : October 15, 2008
Last Update Posted : December 7, 2009
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Brief Summary:
  • To assess the efficacy of docetaxel, cisplatin combination in terms of disease free survival.
  • Time to progression of the disease in terms of local and distant failure; assess the survival time, and assess the objective (clinical and radiological) response rate and the safety of the treatment.

Condition or disease Intervention/treatment Phase
Head and Neck Neoplasms Drug: docetaxel and cisplatin Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 57 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase IV Clinical Study Evaluating The Efficacy of Chemoradiotherapy Following Neoadjuvant Treatment With Docetaxel and Cisplatin in Indifferentiated and Non-keratinized Squamous Cell Carcinoma of Nasopharynx
Study Start Date : October 2004
Actual Primary Completion Date : March 2008
Actual Study Completion Date : March 2008

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 1 Drug: docetaxel and cisplatin
3 cycles of docetaxel 75mg/m2 and 100mg/m2 cisplatin combination every 3 weeks

Primary Outcome Measures :
  1. Complete response rate after neoadjuvant chemotherapy [ Time Frame: From the start date of the treatment to the date of first documented progression of disease or at least until 2 years follow-up period ]

Secondary Outcome Measures :
  1. Percentage of patients whose is disease controlled locally or regionally [ Time Frame: from the start date of the treatment to the date of first documented local or regional tumor progression ]
  2. Median length of overall survival [ Time Frame: time interval from the date of treatment to the date of death or at least until 2 years follow-up period ]
  3. Median length of disease free survival [ Time Frame: time interval from the date of treatment to the date of death or at least until 2 years follow-up period ]
  4. Percentage of alive patients without metastatis [ Time Frame: from the start date of the treatment to the date of first documented distant metastasis ]

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Histologically/cytologically confirmed, patients with stage T2b-T4N1 or TanyN2-3 undifferentiated or nonkeratinized squamous cell carcinoma of nasopharynx who are candidate for curative radiotherapy.
  • ECOG Performance Status is 0-1
  • Weight loss within last 6 months <10% of body weight
  • Acceptable haematological profile (as defined by a leukocyte count ≥ 4000/mm3, a platelet count ≥ 100.000mm3 and Hb ≥ 9g/100mL), and adequate renal function (as defined by serum creatinine ≤ 1.5mg/dl), and hepatic function (as defined by bilirubin ≤ 1.5 x maximum normal value even with hepatic metastasis; transaminases (ALT, AST) ≤ 1.5 x maximum normal value; alkaline phosphatase ≤ 2.5 x maximum normal value, except in case of a bone metastasis)

Exclusion Criteria:

  • Patients with stage IVC or metastatic disease
  • Patients treated with chemotherapy for nasopharyngeal cancer
  • Patients treated with radiotherapy to head and neck region
  • Concomitant use of another anti-cancer therapy
  • Patients treated with amifostine or pilocarpine during protocol treatment.
  • Unstable medical condition that makes the patient unable to take part in a clinical study (congestive heart failure, serious arrhythmia, uncontrolled diabetes mellitus), history of myocardial infarction within last 6 months, massive pleural, peritoneal or pericardial effusion; or presence of serious uncontrolled infection.
  • Presence of other tumours different from carcinoma of the skin except melanoma and carcinoma in situ of the breast and cervix with disease free survival less than 5 years.
  • Pregnancy or breastfeeding. In women of childbearing potential and in men, an adequate contraceptive method must be used
  • Social or psychological condition that render the patient inadequate for the follow-up of the study
  • Contraindication for any of the study drugs (e.g. history of hypersensitivity to any of the ingredients of the study drugs)

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): NCT00772681

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Sanofi-Aventis Administrative Office
Istanbul, Turkey
Sponsors and Collaborators
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Study Director: Edibe Taylan, MD Sanofi
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Responsible Party: Medical Affairs Study Director, Sanofi aventis Identifier: NCT00772681    
Other Study ID Numbers: XRP6976F_6007
First Posted: October 15, 2008    Key Record Dates
Last Update Posted: December 7, 2009
Last Verified: December 2009
Additional relevant MeSH terms:
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Head and Neck Neoplasms
Neoplasms by Site
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action