- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01312311
Weekly Docetaxel Plus Cisplatin as the First-line Therapy for Nasopharyngeal Cancer
March 8, 2011 updated by: Samsung Medical Center
Phase II Trial of Cisplatin Plus Weekly Docetaxel as the First-line Treatment for Recurrent or Metastatic Nasopharyngeal Cancer
The investigators will evaluate weekly docetaxel plus 3-weekly cisplatin regimen as the first-line therapy for recurrent of metastatic nasophayngeal cancer
Study Overview
Study Type
Interventional
Enrollment (Anticipated)
51
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Seoul, Korea, Republic of, 135-710
- Recruiting
- Samsung Medical Center
-
Contact:
- Myung-Ju Ahn, Pf
- Phone Number: 822-3410-3459
- Email: silkahn@skku.edu
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- histologically confirmed nasopharyngeal cancer
- chemotherapy or radiotherapy naive (but, including patients completed 6 months before the enrollment)
- ECOG 0-1
- at least one measurable lesion
Exclusion Criteria:
- other cancer
- pregnat
- docetaxel hypersentitivity history
- severe heart or pulmonary disease
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: weekly docetaxel and cisplatin
Docetaxel 35mg/m2 D1 & D8 Cisplatin 70mg/m2 D1 every 3 weeks maxinum 6 cycles
|
Docetaxel 35mg/m2 D1 & D8 Cisplatin 70mg/m2 D1
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
objective response rate
Time Frame: 6 months after the enrollment of the last patients
|
6 months after the enrollment of the last patients
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
number of patients with adverse events
Time Frame: simultaneously when the analysis of primary endpoint
|
simultaneously when the analysis of primary endpoint
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2006
Primary Completion (Anticipated)
May 1, 2011
Study Registration Dates
First Submitted
February 21, 2011
First Submitted That Met QC Criteria
March 8, 2011
First Posted (Estimate)
March 10, 2011
Study Record Updates
Last Update Posted (Estimate)
March 10, 2011
Last Update Submitted That Met QC Criteria
March 8, 2011
Last Verified
March 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Pharyngeal Neoplasms
- Otorhinolaryngologic Neoplasms
- Head and Neck Neoplasms
- Nasopharyngeal Diseases
- Pharyngeal Diseases
- Stomatognathic Diseases
- Otorhinolaryngologic Diseases
- Nasopharyngeal Carcinoma
- Nasopharyngeal Neoplasms
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Docetaxel
Other Study ID Numbers
- 2006-07-005
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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