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

This study is currently recruiting participants.
Verified August 2010 by Mackay Memorial Hospital
Sponsor:
Information provided by:
Mackay Memorial Hospital
ClinicalTrials.gov Identifier:
NCT00855881
First received: March 4, 2009
Last updated: July 25, 2011
Last verified: August 2010
History of Changes
  Purpose

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.


Condition Intervention Phase
Head and Neck Cancer
 Drug: tegafur-uracil
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Trial of Metronomic Chemotherapy With Tegafur/Uracil for Patients With Locally Advanced (Stage III~IVB) Head and Neck Squamous Cell Carcinoma (HNSCC)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Mackay Memorial Hospital:

Primary Outcome Measures:
  • 2-year RFS [ Time Frame: 6 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival [ Time Frame: 8 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 115
Study Start Date: December 2008
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment arm
Treated with tegafur-uracil for 1 year
 Drug: tegafur-uracil
tegafur-uracil 1 cap, bid for 1 year
Other Name: UFUR

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 Criteria:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00855881

Locations
Taiwan
Mackay Memorial Hospital Recruiting
Taipei, Taiwan
Contact: Ching Lin, BS     +886-2543-3535        
Sub-Investigator: Y.F. Chang            
Sponsors and Collaborators
Mackay Memorial Hospital
Investigators
Principal Investigator: Y. S. Lu, MD Mackay Memorial Hospital
  More Information

No publications provided

Responsible Party: Group of Head and Neck Cancer, Mackay Memorial Hospital, Taipei, Mackay Memorial Hospital, Taipei
ClinicalTrials.gov Identifier: NCT00855881     History of Changes
Other Study ID Numbers: 376
Study First Received: March 4, 2009
Last Updated: July 25, 2011
Health Authority: Taiwan: Department of Health

Keywords provided by Mackay Memorial Hospital:
adjuvant chemotherapy for head and neck cancer

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Neoplasms by Site
 Tegafur
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 21, 2013