Oral Squamous Cell CarcinomaPhase 2NCT02739204
Concurrent Radiotherapy and/or Cisplatin With or Without Celecoxib in Patients With Primary Oral Squamous Cell Carcinoma
A Phase 2 study testing Celecoxib in people with Oral Squamous Cell Carcinoma, run by China Medical University Hospital at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Oral Squamous Cell Carcinoma
- What is being tested?
- Celecoxib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 270 participants
- Where
- 1 siteTaiwan
- Study dates
- Nov 2013to Dec 2017
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- OSCC patients with T1,2/ N0 and without pathological risk features
- OSCC patients with T1,2/ N0,1 and pathological risk features
- OSCC patients with T4a/ N2,3
Who cannot join
- Pregnant women paitents
- Taiwanese aboriginal patients
- Not primary OSCC patients
- OSCC patients with dysfunction of liver and/or kidneys
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Department of Otolaryngology
Taichung, 40447
Ming-Hsul Tsai, M.D. Ph.D., 886-4-22052121 ext. 4436, minghsui@mail.cmuh.org.tw
Chun-Hung Hua, M.D.
About this study
Official title: Development of Novel Diagnostic Tools and Therapeutic Strategies for Oral Cancer
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.
- Conditions
- Oral Squamous Cell Carcinoma
- Being tested
- Celecoxib
- Keywords
- Celecoxib, Relapse-free OSCC patient, Recurrence, Survival, Prognosis
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CelecoxibDrug
Also called Celebrex
200 mg of Celecoxib daily for 6-month treatment after surgery within 1 - 6 months
| Study group | Role | What they receive |
|---|---|---|
| Celecoxib | Experimental | Combination of concurrent radiotherapy and/or Cisplatin with or without Celcoxib Receives: Drug: Celecoxib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relapse-free recurrence
3-year follow-up after 6-month treatment of Celecoxib
Measured: 3 year relapse-free recurrence
Secondary outcomes (1)
Relapse-free survival
3-year follow-up after 6-month treatment of Celecoxib
Measured: 3 year relapse-free survival
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2016 (estimated)
- Study startNov 2013
- Primary completionDec 2016 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral Squamous Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by China Medical University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 270 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health and Welfare, Taiwan
- Responsible party
- Sponsor
- Investigators
- Ying-Chin Ko, MD-PhD, Study chair, Graduate Institute of Clinical Medical Science, China Medical University, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02739204
- Sponsor's protocol ID
- CMUH102-REC1-071
- Status last verified
- Apr 2016
- First submitted
- 22 Mar 2016
- Last updated
- 15 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Novel Diagnostic Tools and Therapeutic Strategies for Oral Cancer
- ClinicalTrials.gov ID
- NCT02739204
- Acronym / sponsor ID
- CMUH102-REC1-071
- Conditions
- Oral Squamous Cell Carcinoma
- Keywords
- Celecoxib, Relapse-free OSCC patient, Recurrence, Survival, Prognosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 270 participants (estimated)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Collaborators
- Ministry of Health and Welfare, Taiwan
- Study start
- Nov 2013
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 15 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Celecoxib | Experimental | Drug: CelecoxibCombination of concurrent radiotherapy and/or Cisplatin with or without Celcoxib |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- OSCC patients with T1,2/ N0 and without pathological risk features
- OSCC patients with T1,2/ N0,1 and pathological risk features
- OSCC patients with T4a/ N2,3
Key exclusion criteria (4 listed)
- Pregnant women paitents
- Taiwanese aboriginal patients
- Not primary OSCC patients
- OSCC patients with dysfunction of liver and/or kidneys
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CelecoxibAlso: Celebrex200 mg of Celecoxib daily for 6-month treatment after surgery within 1 - 6 months | Drug | Celecoxib |
Primary outcome
Relapse-free recurrence
Time frame: 3 year relapse-free recurrence
3-year follow-up after 6-month treatment of Celecoxib
1 secondary outcome
Relapse-free survival
Time frame: 3 year relapse-free survival
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2016.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ying-Chin Ko, MD-PhD study chair
Graduate Institute of Clinical Medical Science, China Medical University, Taiwan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Celecoxib in people with Oral Squamous Cell Carcinoma, run by China Medical University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ying-Chin Ko, MD-PhD (886-4-22052121 ext. 7322, ycko0406@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relapse-free recurrence (time frame: 3 year relapse-free recurrence). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2016.