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

Head and Neck Neoplasms Clinical Trial

— Tax-Nazo  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00772681
• Other study ID #: XRP6976F_6007
• Status: Completed
• Phase: Phase 4
• First received: October 13, 2008
• Last updated: December 4, 2009
• Start date: October 2004
• Est. completion date: March 2008

Study information

• Verified date: December 2009
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: March 2008
• Est. primary completion date: March 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Head and Neck Neoplasms

Intervention

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

Locations

Country	Name	City	State
Turkey	Sanofi-Aventis Administrative Office	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete response rate after neoadjuvant chemotherapy		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	No
Secondary	Percentage of patients whose is disease controlled locally or regionally		from the start date of the treatment to the date of first documented local or regional tumor progression	No
Secondary	Median length of overall survival		time interval from the date of treatment to the date of death or at least until 2 years follow-up period	No
Secondary	Median length of disease free survival		time interval from the date of treatment to the date of death or at least until 2 years follow-up period	No
Secondary	Percentage of alive patients without metastatis		from the start date of the treatment to the date of first documented distant metastasis	No