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Status unknownNCT01312311Updated Mar 10, 2011

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

A Phase 2 interventional study of Docetaxel, Cisplatin in Nasopharyngeal Cancer, sponsored by Samsung Medical Center. Status unknown at 1 site in Korea, Republic of. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-03-10.

Sponsored by Samsung Medical Center · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Mar 2011), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
51
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

  • Nasopharyngeal Cancer

Keywords

  • nasopharyngeal cancer
  • weekly docetaxel
  • cisplatin
03

In context

Nasopharyngeal Neoplasms

240 studies on the registry are indexed under Nasopharyngeal Neoplasms; 47 are open to participants now.

This study's planned enrollment of 51 is below the median of 60 across 198 interventional studies indexed under Nasopharyngeal Neoplasms.

Browse Nasopharyngeal Neoplasms studies →

Lead sponsor

Samsung Medical Center is the lead sponsor of 980 studies on the registry; 146 are open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 1 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • other cancer
  • pregnat
  • docetaxel hypersentitivity history
  • severe heart or pulmonary disease
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
51 participants (estimated)

Study arms

  • Experimental
    weekly docetaxel and cisplatin

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

    Drug: Docetaxel, Cisplatin

Interventions

  • DrugDocetaxel, Cisplatin

    Docetaxel 35mg/m2 D1 \& D8 Cisplatin 70mg/m2 D1

06

What researchers measure

Primary outcomes

  1. objective response rate

    Time frame: 6 months after the enrollment of the last patients

Secondary outcomes

  1. number of patients with adverse events

    Time frame: simultaneously when the analysis of primary endpoint

07

Study locations

1 of 1 sites recruiting
  • Samsung Medical Center
    Seoul, 135-710, Korea, Republic of
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 10, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01312311
Lead sponsor
Samsung Medical Center
First posted
Mar 10, 2011
Start date
Jul 2006
Primary completion
May 2011 (estimated)
Last update
Mar 10, 2011

Study contacts

Myung-Ju Ahn, Pf
Contact
silkahn@skku.edu
82-2-3410-3459

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2011. You cannot join it, but the record below documents what was studied.

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