Back to resultsTaxotere + Cisplatin in Nasopharyngeal Carcinoma
Primary Purpose
Nasopharyngeal Neoplasms
Status
Completed
Phase
Phase 2
Locations
Hong Kong
Study Type
Interventional
Intervention
Docetaxel
Cisplatin
Sponsored by
About this trial
This is an interventional treatment trial for Nasopharyngeal Neoplasms
Eligibility Criteria
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.
Sites / Locations
- Sanofi-Aventis
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
Neo-adjuvant Taxotere followed by cisplatin and radiotherapy
Cisplatin and radiotherapy alone without neo-adjuvant chemotherapy
Outcomes
Primary Outcome Measures
Treatment response is evaluated by correlating findings on clinical examination, endoscopy, biopsy, Computed tomography or Magnetic resonance imaging as appropriate.
Secondary Outcome Measures
Adverse Events
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00436293
Brief Title
Taxotere + Cisplatin in Nasopharyngeal Carcinoma
Official Title
A Randomized Phase II Study of Concurrent Cisplatin-radiotherapy With or Without Neoadjuvant Chemotherapy Using Taxotere and Cisplatin in Advanced Nasopharyngeal Carcinoma (NPC)
Study Type
Interventional
2. Study Status
Record Verification Date
November 2010
Overall Recruitment Status
Completed
Study Start Date
December 2002 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
March 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Sanofi
4. Oversight
5. Study Description
Brief Summary
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nasopharyngeal Neoplasms
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
61 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Neo-adjuvant Taxotere followed by cisplatin and radiotherapy
Arm Title
2
Arm Type
Active Comparator
Arm Description
Cisplatin and radiotherapy alone without neo-adjuvant chemotherapy
Intervention Type
Drug
Intervention Name(s)
Docetaxel
Intervention Description
75 mg/m²
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Intervention Description
75 mg/m²
Primary Outcome Measure Information:
Title
Treatment response is evaluated by correlating findings on clinical examination, endoscopy, biopsy, Computed tomography or Magnetic resonance imaging as appropriate.
Time Frame
From administration of drug to end of study
Secondary Outcome Measure Information:
Title
Adverse Events
Time Frame
From administration of drug to end of study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Iris Chan
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Sanofi-Aventis
City
Hong Kong
Country
Hong Kong
12. IPD Sharing Statement
Learn more about this trial
Taxotere + Cisplatin in Nasopharyngeal Carcinoma
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