NCT00855881

Brief Summary

It is the investigators understanding that the combination of clinical trial with laboratory cellular/molecular assay is relevant to the current promising mainstream, the translational research. The design of this trial fulfills this concept and would be a good example conducting in Mackay Memorial hospital.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
115

participants targeted

Target at P75+ for phase_2 head-and-neck-cancer

Timeline
Completed

Started Dec 2008

Longer than P75 for phase_2 head-and-neck-cancer

Geographic Reach
1 country

1 active site

Status
unknown

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
3 months until next milestone

First Submitted

Initial submission to the registry

March 4, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 5, 2009

Completed
5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

July 26, 2011

Status Verified

August 1, 2010

Enrollment Period

6 years

First QC Date

March 4, 2009

Last Update Submit

July 25, 2011

Conditions

Head and Neck Cancer

Keywords

adjuvant chemotherapy for head and neck cancer

Outcome Measures

Primary Outcomes (1)

  • 2-year RFS

    6 years

Secondary Outcomes (1)

  • Overall survival

    8 year

Study Arms (1)

Treatment arm

EXPERIMENTAL

Treated with tegafur-uracil for 1 year

Drug: tegafur-uracil

Interventions

tegafur-uracilDRUG

tegafur-uracil 1 cap, bid for 1 year

Also known as: UFUR
Treatment arm

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically confirmed non-nasopharyngeal head and neck squamous cell carcinoma
  • Complete response(CR) to previous treatment
  • White blood cell (WBC) count greater than 3,000/mm3 and absolute neutrophil count (ANC) greater than 1,500/mm3, and platelets greater than 50,000/mm3
  • Serum bilirubin less than 2 times the upper limit of normal range (ULN)
  • Alanine aminotransferase (ALT) or aspartate aminotransferase (AST)
  • Serum creatinine less than 2.0 times the ULN
  • ECOG performance status 0, 1, 2
  • Age, 20 years or older

You may not qualify if:

  • Other malignancy, with the exception of curatively treated non-melanoma skin cancer or cervical carcinoma in situ prior to commencement of the study
  • CR was confirmed more than 6 weeks prior to commencement of the study
  • Concurrent treatment which may interfere with evaluation
  • Pregnancy or breast feeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mackay Memorial Hospital

Taipei, Taiwan

RECRUITING

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

Tegafur

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasms

Intervention Hierarchy (Ancestors)

FluorouracilUracilPyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Y. S. Lu, MD

    Mackay Memorial Hospital

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

March 4, 2009

First Posted

March 5, 2009

Study Start

December 1, 2008

Primary Completion

December 1, 2014

Study Completion

December 1, 2016

Last Updated

July 26, 2011

Record last verified: 2010-08

Locations

TW(1)