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

China Medical University

Status and phase: Unknown; Phase 2

Conditions: Oral Squamous Cell Carcinoma

Treatments: Drug: Celecoxib

Study type: Interventional

Funder types: Other

Identifiers

NCT02739204

CMUH102-REC1-071

Details and patient eligibility

About

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.

Full 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.

Enrollment: 270 estimated patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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270 participants in 1 patient group

Celecoxib

Experimental group

Description:

Combination of concurrent radiotherapy and/or Cisplatin with or without Celcoxib

Treatment:

Drug: Celecoxib