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

This study is currently recruiting participants.

Verified by Mackay Memorial Hospital, March 2009

First Received: March 4, 2009 Last Updated: March 24, 2009 History of Changes

Sponsored by:	Mackay Memorial Hospital
Information provided by:	Mackay Memorial Hospital
ClinicalTrials.gov Identifier:	NCT00855881

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 II

MedlinePlus related topics: Cancer Head and Neck Cancer

Drug Information available for: Uracil Tegafur

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Efficacy Study
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)

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
Treatment arm: Experimental Treated with tegafur-uracil for 1 year	Drug: tegafur-uracil tegafur-uracil 1 cap, bid for 1 year

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 billirubin 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:	Mackay Memorial Hospital, Taipei ( Group of Head and Neck Cancer, Mackay Memorial Hospital, Taipei )
Study ID Numbers:	376
Study First Received:	March 4, 2009
Last Updated:	March 24, 2009
ClinicalTrials.gov Identifier:	NCT00855881 History of Changes
Health Authority:	Taiwan: Department of Health

Keywords provided by Mackay Memorial Hospital:

adjuvant chemotherapy for head and neck cancer

Study placed in the following topic categories:

Antimetabolites
Tegafur
Head and Neck Neoplasms
Epidermoid Carcinoma
Adjuvants, Immunologic
Carcinoma, Squamous Cell of Head and Neck

Neoplasms, Squamous Cell
Squamous Cell Carcinoma
Carcinoma, Squamous Cell
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:

Antimetabolites
Neoplasms by Histologic Type
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Tegafur
Pharmacologic Actions
Carcinoma

Neoplasms
Neoplasms by Site
Therapeutic Uses
Head and Neck Neoplasms
Neoplasms, Squamous Cell
Carcinoma, Squamous Cell
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on May 06, 2009