Clinical trial NCT00772681: Efficacy of Chemoradiotherapy After Neoadjuvant Cisplatin and Docetaxel in the Nasopharynx Carcinoma
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Head and Neck Neoplasms
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2008-10-15
Enrollment: 57
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Complete response rate after neoadjuvant chemotherapy
timeFrame: 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:
measure: Percentage of patients whose is disease controlled locally or regionally
timeFrame: from the start date of the treatment to the date of first documented local or regional tumor progression
measure: Median length of overall survival
timeFrame: time interval from the date of treatment to the date of death or at least until 2 years follow-up period
measure: Median length of disease free survival
timeFrame: time interval from the date of treatment to the date of death or at least until 2 years follow-up period
measure: Percentage of alive patients without metastatis
timeFrame: from the start date of the treatment to the date of first documented distant metastasis
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Sanofi-Aventis Administrative Office
Study officials:
affiliation: Sanofi
name: Edibe Taylan, MD
role: STUDY_DIRECTOR
References: