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

Phase 2

• Conditions: Nasopharyngeal Cancer
• Interventions: Drug: Docetaxel, Cisplatin

• Registration Number: NCT01312311
• Lead Sponsor: Samsung Medical Center

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2006-07
• Study First Submitted: 2011-02-21
• Status Verified: 2011-03
• Study First Submitted QC: 2011-03-08
• Last Update Submitted: 2011-03-08
• Study First Posted: 2011-03-10
• Last Update Posted: 2011-03-10
• Primary Completion: 2011-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 51

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
weekly docetaxel and cisplatin	Docetaxel, Cisplatin	Docetaxel 35mg/m2 D1 \& D8 Cisplatin 70mg/m2 D1 every 3 weeks maxinum 6 cycles

Primary Outcome Measures

Name	Time	Method
objective response rate	6 months after the enrollment of the last patients

Secondary Outcome Measures

Name	Time	Method
number of patients with adverse events	simultaneously when the analysis of primary endpoint

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of