Status:

UNKNOWN

Metronomic Chemotherapy With Tegafur/Uracil for Head and Neck Squamous Cell Carcinoma

Lead Sponsor:

Mackay Memorial Hospital

Conditions:

Head and Neck Cancer

Eligibility:

All Genders

20+ years

Phase:

PHASE2

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 d...

Detailed Description

Head and neck squamous cell carcinoma (HNSCC) (excluding nasopharyngeal cancer) accounts for 4% to 5% of the cancer incidence in Taiwan.1 Localized disease is curable by surgery and irradiation. Two-t...

Eligibility Criteria

Inclusion

  • 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

Exclusion

  • 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

Key Trial Info

Start Date :

December 1 2008

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 1 2016

Estimated Enrollment :

115 Patients enrolled

Trial Details

Trial ID

NCT00855881

Start Date

December 1 2008

End Date

December 1 2016

Last Update

July 26 2011

Active Locations (1)

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1

Mackay Memorial Hospital

Taipei, Taiwan