Clinical Trial: Concurrent Radiotherapy and/or Cisplatin With or Without Celecoxib in Patients With Primary Oral Squamous Cell Carcinoma

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Development of Novel Diagnostic Tools and Therapeutic Strategies for Oral Cancer

Brief Summary: The research and development of novel anti-tumor agents in oral cancer is slow, the investigation of repositioning use of currently available drugs in clinical, such as a selective cyclooxygenase-2 (COX-2) inhibitor (Celebrex/Celecoxib) maybe a potential alternative strategy.

Detailed Summary: Celebrex (Celecoxib) is a form of non-steroidal anti-inflammatory drug that directly targets COX-2 enzyme to block the inflammatory signaling and has been approved to treat colon cancer. In our preliminary findings, Celecoxib significantly inhibited cell growth,proliferation, migration, invasion and epithelial-mesenchymal transition programs in oral squamous cell carcinoma cell (OSCC) lines. The Institutional Review Board in China Medical University Hospital (CMUH) has approved the combination treatment of concurrent radiotherapy (RT) and/or Cisplatin with or without Celecoxib in a phase II clinical trial for relapse-free primary OSCC patients.
Sponsor: China Medical University Hospital

Current Primary Outcome: Relapse-free recurrence [ Time Frame: 3 year relapse-free recurrence ]

3-year follow-up after 6-month treatment of Celecoxib


Original Primary Outcome: Same as current

Current Secondary Outcome: Relapse-free survival [ Time Frame: 3 year relapse-free survival ]

3-year follow-up after 6-month treatment of Celecoxib


Original Secondary Outcome: Same as current

Information By: China Medical University Hospital

Dates:
Date Received: March 22, 2016
Date Started: November 2013
Date Completion: December 2017
Last Updated: April 11, 2016
Last Verified: April 2016