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

NCT ID: NCT00805012

Last Updated: 2011-07-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-12-31

Study Completion Date

2011-07-31

Brief Summary

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

Detailed Description

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Conditions

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Head and Neck Squamous Cell Carcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

docetaxel+CDDP

Group Type ACTIVE_COMPARATOR

docetaxel+CDDP

Intervention Type DRUG

docetaxel+CDDP

2

docetaxel+S-1

Group Type EXPERIMENTAL

docetaxel+S-1

Intervention Type DRUG

docetaxel+S-1

Interventions

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docetaxel+CDDP

docetaxel+CDDP

Intervention Type DRUG

docetaxel+S-1

docetaxel+S-1

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Clinical Research Center for Solid Tumor, Korea

OTHER

Sponsor Role collaborator

Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Clinical Research Center for Solid Tumor, Korea

Locations

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Seoul National University Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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CRCST-L-0004

Identifier Type: -

Identifier Source: org_study_id

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