Taxotere + Cisplatin in Nasopharyngeal Carcinoma

Sanofi

Status and phase: Completed; Phase 2

Conditions: Nasopharyngeal Neoplasms

Treatments: Drug: Docetaxel; Drug: Cisplatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00436293

XRP6976F_6002

Details and patient eligibility

About

Primary objective:

To assess and compare the toxicities of patients with advanced NPC treated with concurrent cisplatin-radiotherapy with or without neoadjuvant Taxotere (docetaxel) and cisplatin.

Secondary objective:

To assess tumor control and survival

Enrollment: 61 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• International Union against Cancer stages III and IV newly diagnosed NPC

Exclusion criteria

• Inadequate bone marrow reserve
• Inadequate renal function
• Other primary malignancy
• Evidence of distant metastases

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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61 participants in 2 patient groups

1

Experimental group

Description:

Neo-adjuvant Taxotere followed by cisplatin and radiotherapy

Treatment:

Drug: Docetaxel

2

Active Comparator group

Description:

Cisplatin and radiotherapy alone without neo-adjuvant chemotherapy

Treatment:

Drug: Cisplatin