Status:
COMPLETED
Efficacy of Chemoradiotherapy After Neoadjuvant Cisplatin and Docetaxel in the Nasopharynx Carcinoma
Lead Sponsor:
Sanofi
Conditions:
Head and Neck Neoplasms
Eligibility:
All Genders
19+ years
Phase:
PHASE4
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, an...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2008
Estimated Enrollment :
57 Patients enrolled
Trial Details
Trial ID
NCT00772681
Start Date
October 1 2004
End Date
March 1 2008
Last Update
December 7 2009
Active Locations (1)
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1
Sanofi-Aventis Administrative Office
Istanbul, Turkey (Türkiye)