NCT00805012

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
96

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Dec 2008

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2008

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

December 6, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 9, 2008

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
Last Updated

July 26, 2011

Status Verified

July 1, 2011

Enrollment Period

2.6 years

First QC Date

December 6, 2008

Last Update Submit

July 23, 2011

Conditions

Head and Neck Squamous Cell Carcinoma

Keywords

S-1docetaxelhead and neck cancerRecurrent or metastatic head and neck squamous cell carcinoma

Outcome Measures

Primary Outcomes (1)

  • Response rate

Secondary Outcomes (4)

  • progression-free survival

  • duration of response

  • overall survival

  • safety

Study Arms (2)

1

ACTIVE COMPARATOR

docetaxel+CDDP

Drug: docetaxel+CDDP

2

EXPERIMENTAL

docetaxel+S-1

Drug: docetaxel+S-1

Interventions

docetaxel+CDDPDRUG

docetaxel+CDDP

1
docetaxel+S-1DRUG

docetaxel+S-1

2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)
  • years or older
  • ECOG 0 or 1
  • adequate laboratory result
  • written, informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and NeckHead and Neck NeoplasmsRecurrence

Condition Hierarchy (Ancestors)

Carcinoma, Squamous CellCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNeoplasms by SiteDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 6, 2008

First Posted

December 9, 2008

Study Start

December 1, 2008

Primary Completion

July 1, 2011

Study Completion

July 1, 2011

Last Updated

July 26, 2011

Record last verified: 2011-07

Locations

KR(1)