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Completed

NCT Number: NCT00772681

Efficacy of Chemoradiotherapy After Neoadjuvant Cisplatin and Docetaxel in the Nasopharynx Carcinoma

* 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.

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Key information

Conditions

Head and Neck Neoplasms Neoplasms Neoplasms by Site

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Sanofi-Aventis Administrative Office

Istanbul, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Docetaxel and Cisplatin

Drug

3 cycles of docetaxel 75mg/m2 and 100mg/m2 cisplatin combination every 3 weeks

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study 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

Acronym: Tax-Nazo

Important dates

Study start
2004
Primary completion
2008
Study completion
2008
First posted
Oct 15, 2008
Registry last updated
Dec 7, 2009

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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