Docetaxel and S-1 in Head and Neck Squamous Cell Carcinoma (HNSCC)

July 23, 2011 updated by: Seoul National University Hospital

A Randomized, Multicenter, Phase II Study of Docetaxel and TS-1 Combination as a First-line Treatment in Metastatic or Recurrent Head and Neck Squamous Cell Carcinoma (HNSCC)

To assess response rate of docetaxel and S-1 combination in metastatic or recurrent head and neck squamous cell carcinoma

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

96

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

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 HNSCC
  • adequate primary site: oral cavity, oropharynx, hypopharynx, nasal cavity, paranasal sinus, other head and neck site (except nasopharynx)
  • at least one measurable lesion
  • no previous palliative chemotherapy (adjuvant/neoadjuvant chemotherapy and/or radiotherapy longer than 6 months ago is permitted)
  • 18 years or older
  • ECOG 0 or 1
  • adequate laboratory result
  • written, informed consent

Exclusion Criteria:

  • pregnant or lactating women (negative pregnancy test within 7 days is required for women with potential of child-bearing)
  • experimental drug clinical trial within 30 days
  • other malignancy (exemption: treated basal cell carcinoma of skin, CIS, cured cancer with disease-free interval with more than 5 years)
  • patient with organ transplantation
  • grade 2 or more peripheral neuropathy
  • grade 2 or more hearing loss
  • severe, medical condition

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: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: 1
docetaxel+CDDP
Drug: docetaxel+CDDP
docetaxel+CDDP
EXPERIMENTAL: 2
docetaxel+S-1
Drug: docetaxel+S-1
docetaxel+S-1

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Response rate

Secondary Outcome Measures

Outcome Measure
overall survival
safety
progression-free survival
duration of response

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Collaborators

Clinical Research Center for Solid Tumor, Korea

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

December 1, 2008

Primary Completion (ANTICIPATED)

July 1, 2011

Study Completion (ANTICIPATED)

July 1, 2011

Study Registration Dates

First Submitted

December 6, 2008

First Submitted That Met QC Criteria

December 8, 2008

First Posted (ESTIMATE)

December 9, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

July 26, 2011

Last Update Submitted That Met QC Criteria

July 23, 2011

Last Verified

July 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRCST-L-0004

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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