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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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25 April 2016 |
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Main ID: |
NCT02739204 |
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Date of registration:
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22/03/2016 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Concurrent Radiotherapy and/or Cisplatin With or Without Celecoxib in Patients With Primary Oral Squamous Cell Carcinoma
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Scientific title:
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Development of Novel Diagnostic Tools and Therapeutic Strategies for Oral Cancer |
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Date of first enrolment:
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November 2013 |
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Target sample size:
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270 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT02739204 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
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Phase:
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Phase 2
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Countries of recruitment
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Taiwan
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Contacts
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Name:
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Ming-Hsul Tsai, M.D. Ph.D. |
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Address:
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Telephone:
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886-4-22052121 |
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Email:
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minghsui@mail.cmuh.org.tw |
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Affiliation:
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Name:
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Ying-Chin Ko, MD-PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Graduate Institute of Clinical Medical Science, China Medical University, Taiwan |
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Name:
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Ying-Chin Ko, MD-PhD |
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Address:
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Telephone:
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886-4-22052121 |
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Email:
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ycko0406@gmail.com |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. OSCC patients with T1,2/ N0 and without pathological risk features
2. OSCC patients with T1,2/ N0,1 and pathological risk features
3. OSCC patients with T4a/ N2,3
Exclusion Criteria:
1. Pregnant women paitents
2. Taiwanese aboriginal patients
3. Not primary OSCC patients
4. OSCC patients with dysfunction of liver and/or kidneys
Age minimum:
20 Years
Age maximum:
80 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Oral Squamous Cell Carcinoma
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Intervention(s)
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Drug: Celecoxib
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Primary Outcome(s)
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Relapse-free recurrence
[Time Frame: 3 year relapse-free recurrence]
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Secondary Outcome(s)
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Relapse-free survival
[Time Frame: 3 year relapse-free survival]
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Secondary ID(s)
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CMUH102-REC1-071
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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