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

NCT ID: NCT02739204

Last Updated: 2016-04-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

270 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-30

Study Completion Date

2017-12-31

Brief Summary

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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

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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

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Oral Squamous Cell Carcinoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Celecoxib

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

Group Type EXPERIMENTAL

Celecoxib

Intervention Type DRUG

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

Interventions

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Celecoxib

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

Intervention Type DRUG

Other Intervention Names

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Celebrex

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ministry of Health and Welfare, Taiwan

OTHER_GOV

Sponsor Role collaborator

China Medical University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ying-Chin Ko, MD-PhD

Role: STUDY_CHAIR

Graduate Institute of Clinical Medical Science, China Medical University, Taiwan

Locations

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Department of Otolaryngology

Taichung, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Ying-Chin Ko, MD-PhD

Role: CONTACT

886-4-22052121 ext. 7322

Facility Contacts

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Ming-Hsul Tsai, M.D. Ph.D.

Role: primary

886-4-22052121 ext. 4436

Other Identifiers

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CMUH102-REC1-071

Identifier Type: -

Identifier Source: org_study_id

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