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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
Recruitment status was: Recruiting
Sponsor:
Mackay Memorial Hospital
Information provided by:
Mackay Memorial Hospital
ClinicalTrials.gov Identifier:
NCT00855881
First received: March 4, 2009
Last updated: July 25, 2011
Last verified: August 2010
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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 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:
Genetics Home Reference related topics:
head and neck squamous cell carcinoma
MedlinePlus related topics:
Head and Neck Cancer
U.S. FDA Resources
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
Eligibility| Ages Eligible for Study: | 20 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| 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
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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 ClinicalTrials.gov identifier: NCT00855881
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
| 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 |
Keywords provided by Mackay Memorial Hospital:
|
adjuvant chemotherapy for head and neck cancer |
Additional relevant MeSH terms:
|
Carcinoma, Squamous Cell Head and Neck Neoplasms Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Neoplasms, Squamous Cell |
Neoplasms by Site Tegafur Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antineoplastic Agents |
ClinicalTrials.gov processed this record on July 17, 2017