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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.
 
ClinicalTrials.gov Identifier: NCT00772681
Recruitment Status : Completed
First Posted : October 15, 2008
Last Update Posted : December 7, 2009
Sponsor:
Information provided by:
Sanofi

Tracking Information
First Submitted Date  ICMJE October 13, 2008
First Posted Date  ICMJE October 15, 2008
Last Update Posted Date December 7, 2009
Study Start Date  ICMJE October 2004
Actual Primary Completion Date March 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 19, 2009)
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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: October 14, 2008)
Efficacy by disease free survival [ Time Frame: After neoadjuvant treatment and during the follow up period (2 years) ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 19, 2009)
  • 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 ]
  • 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 ]
  • 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 ]
  • Percentage of alive patients without metastatis [ Time Frame: from the start date of the treatment to the date of first documented distant metastasis ]
Original Secondary Outcome Measures  ICMJE
 (submitted: October 14, 2008)
  • Efficacy by time to progression of the disease in terms of local and distant failure; [ Time Frame: Until Progression ]
  • Efficacy by the survival time [ Time Frame: 2 years after the end of treatment ]
  • The objective (clinical and radiological) response rate [ Time Frame: 2 years after the treatment ]
  • The safety of the treatment. [ Time Frame: Throughout the study ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy of Chemoradiotherapy After Neoadjuvant Cisplatin and Docetaxel in the Nasopharynx Carcinoma
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Head and Neck Neoplasms
Intervention  ICMJE Drug: docetaxel and cisplatin
3 cycles of docetaxel 75mg/m2 and 100mg/m2 cisplatin combination every 3 weeks
Study Arms  ICMJE Experimental: 1
Intervention: Drug: docetaxel and cisplatin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 14, 2008)
57
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2008
Actual Primary Completion Date March 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Turkey
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00772681
Other Study ID Numbers  ICMJE XRP6976F_6007
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Medical Affairs Study Director, Sanofi aventis
Study Sponsor  ICMJE Sanofi
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Edibe Taylan, MD Sanofi
PRS Account Sanofi
Verification Date December 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP