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

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00772681
First received: October 13, 2008
Last updated: December 4, 2009
Last verified: December 2009
  Purpose
  • 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 Intervention Phase
Head and Neck Neoplasms
Drug: docetaxel and cisplatin
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Percentage of alive patients without metastatis [ Time Frame: from the start date of the treatment to the date of first documented distant metastasis ] [ Designated as safety issue: No ]

Enrollment: 57
Study Start Date: October 2004
Study Completion Date: March 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: docetaxel and cisplatin
3 cycles of docetaxel 75mg/m2 and 100mg/m2 cisplatin combination every 3 weeks

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00772681

Locations
Turkey
Sanofi-Aventis Administrative Office
Istanbul, Turkey
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Edibe Taylan, MD Sanofi
  More Information

No publications provided

Responsible Party: Medical Affairs Study Director, Sanofi aventis
ClinicalTrials.gov Identifier: NCT00772681     History of Changes
Other Study ID Numbers: XRP6976F_6007
Study First Received: October 13, 2008
Last Updated: December 4, 2009
Health Authority: Turkey: Ethics Committee

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms
Neoplasms by Site
Cisplatin
Docetaxel
Antimitotic Agents
Antineoplastic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Radiation-Sensitizing Agents
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on October 22, 2014