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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2010 by Mackay Memorial Hospital.
Recruitment status was:  Recruiting
Information provided by:
Mackay Memorial Hospital Identifier:
First received: March 4, 2009
Last updated: July 25, 2011
Last verified: August 2010
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
Intervention Model: Single Group Assignment
Masking: None (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:

Further study details as provided by Mackay Memorial Hospital:

Primary Outcome Measures:
  • 2-year RFS [ Time Frame: 6 years ]

Secondary Outcome Measures:
  • Overall survival [ Time Frame: 8 year ]

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


Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00855881

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

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

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

Additional relevant MeSH terms:
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Squamous Cell
Neoplasms by Site
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents processed this record on August 22, 2017