Docetaxel and S-1 in Head and Neck Squamous Cell Carcinom... | NCT00805012

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

NCT00805012

Sponsor

Seoul National University Hospital

Status

Terminated

Last Update Posted

Jul 26, 2011Estimated

Enrollment

96Estimated

Phase

Phase 2

Conditions

Head and Neck Squamous Cell Carcinoma

Interventions

docetaxel+CDDP
docetaxel+S-1

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2011

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

slow accrual rate

Expanded Access Info

Start Date

Dec 2008

Primary Completion Date

Jul 2011Estimated

Completion Date

Jul 2011Estimated

First Submitted Date

Dec 6, 2008

First Submission Date that Met QC Criteria

Dec 8, 2008

First Posted Date

Dec 9, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 23, 2011

Last Update Posted Date

Jul 26, 2011Estimated

Name	Class
Clinical Research Center for Solid Tumor, Korea	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

96Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Active Comparator	docetaxel+CDDP	Drug: docetaxel+CDDP
2	Experimental	docetaxel+S-1	Drug: docetaxel+S-1

Interventions

Name	Type	Description	Arm Group Labels	Other Names
docetaxel+CDDP	Drug	docetaxel+CDDP	1
docetaxel+S-1

Measure	Description	Time Frame
Response rate

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000077195	Squamous Cell Carcinoma of Head and Neck
D006258	Head and Neck Neoplasms
D012008	Recurrence

Ancestor Terms

ID	Term
D002294	Carcinoma, Squamous Cell
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type

Browse Leaves

Not provided

Browse Branches

Not provided

Measure	Description	Time Frame
progression-free survival
duration of response
overall survival