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Weekly Docetaxel Plus Cisplatin as the First-line Therapy for Nasopharyngeal Cancer

Primary Purpose

Nasopharyngeal Cancer

Status
Unknown status
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Docetaxel, Cisplatin
Sponsored by
Samsung Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nasopharyngeal Cancer focused on measuring nasopharyngeal cancer, weekly docetaxel, cisplatin

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Samsung Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

weekly docetaxel and cisplatin

Arm Description

Docetaxel 35mg/m2 D1 & D8 Cisplatin 70mg/m2 D1 every 3 weeks maxinum 6 cycles

Outcomes

Primary Outcome Measures

objective response rate

Secondary Outcome Measures

number of patients with adverse events

Full Information

First Posted
February 21, 2011
Last Updated
March 8, 2011
Sponsor
Samsung Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01312311
Brief Title
Weekly Docetaxel Plus Cisplatin as the First-line Therapy for Nasopharyngeal Cancer
Official Title
Phase II Trial of Cisplatin Plus Weekly Docetaxel as the First-line Treatment for Recurrent or Metastatic Nasopharyngeal Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
March 2011
Overall Recruitment Status
Unknown status
Study Start Date
July 2006 (undefined)
Primary Completion Date
May 2011 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Samsung Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The investigators will evaluate weekly docetaxel plus 3-weekly cisplatin regimen as the first-line therapy for recurrent of metastatic nasophayngeal cancer

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nasopharyngeal Cancer
Keywords
nasopharyngeal cancer, weekly docetaxel, cisplatin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
51 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
weekly docetaxel and cisplatin
Arm Type
Experimental
Arm Description
Docetaxel 35mg/m2 D1 & D8 Cisplatin 70mg/m2 D1 every 3 weeks maxinum 6 cycles
Intervention Type
Drug
Intervention Name(s)
Docetaxel, Cisplatin
Intervention Description
Docetaxel 35mg/m2 D1 & D8 Cisplatin 70mg/m2 D1
Primary Outcome Measure Information:
Title
objective response rate
Time Frame
6 months after the enrollment of the last patients
Secondary Outcome Measure Information:
Title
number of patients with adverse events
Time Frame
simultaneously when the analysis of primary endpoint

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Myung-Ju Ahn, Pf
Phone
82-2-3410-3459
Email
silkahn@skku.edu
Facility Information:
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Myung-Ju Ahn, Pf
Phone
822-3410-3459
Email
silkahn@skku.edu

12. IPD Sharing Statement

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Weekly Docetaxel Plus Cisplatin as the First-line Therapy for Nasopharyngeal Cancer

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