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

Phase 2

• Conditions: Oral Squamous Cell Carcinoma
• Interventions: Drug: Celecoxib

• Registration Number: NCT02739204
• Lead Sponsor: China Medical University Hospital

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 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.

Study Timeline

• Study Start: 2013-11
• Study First Submitted: 2016-03-22
• Status Verified: 2016-04
• Study First Submitted QC: 2016-04-11
• Last Update Submitted: 2016-04-11
• Study First Posted: 2016-04-15
• Last Update Posted: 2016-04-15
• Primary Completion: 2016-12
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 270

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Celecoxib	Celecoxib	Combination of concurrent radiotherapy and/or Cisplatin with or without Celcoxib

Primary Outcome Measures

Name	Time	Method
Relapse-free recurrence	3 year relapse-free recurrence	3-year follow-up after 6-month treatment of Celecoxib

Secondary Outcome Measures

Name	Time	Method
Relapse-free survival	3 year relapse-free survival	3-year follow-up after 6-month treatment of Celecoxib

Trial Locations

Locations (1)

Department of Otolaryngology; 🇨🇳 Taichung, Taiwan