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

Development of Novel Diagnostic Tools and Therapeutic Strategies for Oral Cancer

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02739204

Enrollment

270

Registered

2016-04-15

Start date

2013-11-30

Completion date

2017-12-31

Last updated

2016-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Oral Squamous Cell Carcinoma

Keywords

Celecoxib, Relapse-free OSCC patient, Recurrence, Survival, Prognosis

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.

Interventions

DRUGCelecoxib

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to 80 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Relapse-free recurrence	3 year relapse-free recurrence	3-year follow-up after 6-month treatment of Celecoxib

Secondary

Measure	Time frame	Description
Relapse-free survival	3 year relapse-free survival	3-year follow-up after 6-month treatment of Celecoxib

Countries

Taiwan

Contacts

Primary ContactYing-Chin Ko, MD-PhD

ycko0406@gmail.com886-4-22052121

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026