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

NCT ID: NCT00772681

Last Updated: 2009-12-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 57 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-10-31
• Study Completion Date: 2008-03-31

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.

Conditions

Head and Neck Neoplasms

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Group Type: EXPERIMENTAL

docetaxel and cisplatin

Intervention Type: DRUG

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

Interventions

docetaxel and cisplatin

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

Intervention Type: DRUG

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.

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: lead

Responsible Party

Sanofi aventis

Principal Investigators

Edibe Taylan, MD

Role: STUDY_DIRECTOR

Sanofi

Locations

Sanofi-Aventis Administrative Office

Istanbul, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

XRP6976F_6007

Identifier Type: -

Identifier Source: org_study_id