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

Oral Squamous Cell Carcinoma Clinical Trial

Official title:

Development of Novel Diagnostic Tools and Therapeutic Strategies for Oral Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02739204
• Other study ID #: CMUH102-REC1-071
• Status: Recruiting
• Phase: Phase 2
• First received: March 22, 2016
• Last updated: April 11, 2016
• Start date: November 2013
• Est. completion date: December 2017

Study information

• Verified date: April 2016
• Source: China Medical University Hospital
• Contact: Ying-Chin Ko, MD-PhD
• Phone: 886-4-22052121
• Email: ycko0406[@]gmail.com
• Is FDA regulated: No
• Health authority: Taiwan : Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 270
• Est. completion date: December 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

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

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Carcinoma, Squamous Cell
• Oral Squamous Cell Carcinoma

Intervention

Drug:
• Celecoxib
200 mg of Celecoxib daily for 6-month treatment after surgery within 1 - 6 months

Locations

Country	Name	City	State
Taiwan	Department of Otolaryngology	Taichung

Sponsors (2)

Lead Sponsor	Collaborator
China Medical University Hospital	Ministry of Health and Welfare, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Relapse-free recurrence	3-year follow-up after 6-month treatment of Celecoxib	3 year relapse-free recurrence	Yes
Secondary	Relapse-free survival	3-year follow-up after 6-month treatment of Celecoxib	3 year relapse-free survival	Yes