CClinicalTrials.gg
Status unknownNCT02739204Updated Apr 15, 2016

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

A Phase 2 interventional study of Celecoxib in Oral Squamous Cell Carcinoma, sponsored by China Medical University Hospital. Status unknown at 1 site in Taiwan. Open to participants aged 20 Years to 80 Years. Per ClinicalTrials.gov, last updated 2016-04-15.

Sponsored by China Medical University Hospital · Phase 2, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Apr 2016), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
270
Allocation
Not applicable
Ages
20 Years to 80 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Oral Squamous Cell Carcinoma

Keywords

  • Celecoxib
  • Relapse-free OSCC patient
  • Recurrence
  • Survival
  • Prognosis
03

In context

Carcinoma

6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.

This study's planned enrollment of 270 is above the median of 45 across 5,170 interventional studies indexed under Carcinoma.

Browse Carcinoma studies →

Lead sponsor

China Medical University Hospital is the lead sponsor of 464 studies on the registry; 116 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 2
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
270 participants (estimated)

Study arms

  • Experimental
    Celecoxib

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

    Drug: Celecoxib

Interventions

  • DrugCelecoxib

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

    Also known as: Celebrex

06

What researchers measure

Primary outcomes

  1. Relapse-free recurrence

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

    Time frame: 3 year relapse-free recurrence

Secondary outcomes

  1. Relapse-free survival

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

    Time frame: 3 year relapse-free survival

07

Study locations

1 of 1 sites recruiting
  • Department of Otolaryngology
    Taichung, 40447, Taiwan
    • Ming-Hsul Tsai, M.D. Ph.D. · Contact · minghsui@mail.cmuh.org.tw · 886-4-22052121
    • Chun-Hung Hua, M.D. · Principal investigator
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 15, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02739204
Lead sponsor
China Medical University Hospital
Collaborators
Ministry of Health and Welfare, Taiwan
Responsible party
Sponsor
First posted
Apr 15, 2016
Start date
Nov 2013
Primary completion
Dec 2016 (estimated)
Completion
Dec 2017 (estimated)
Last update
Apr 15, 2016

Study contacts

Ying-Chin Ko, MD-PhD
Contact
ycko0406@gmail.com
886-4-22052121 ext. 7322
Ying-Chin Ko, MD-PhD
study chair · Graduate Institute of Clinical Medical Science, China Medical University, Taiwan

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2016. You cannot join it, but the record below documents what was studied.

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