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

Primary Purpose

Oral Squamous Cell Carcinoma

Status

Unknown status

Phase

Phase 2

Locations

Taiwan

Study Type

Interventional

Intervention

Celecoxib

About this trial

This is an interventional prevention trial for Oral Squamous Cell Carcinoma focused on measuring Celecoxib, Relapse-free OSCC patient, Recurrence, Survival, Prognosis

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

Pregnant women paitents
Taiwanese aboriginal patients
Not primary OSCC patients
OSCC patients with dysfunction of liver and/or kidneys

Sites / Locations

Department of OtolaryngologyRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Celecoxib

Arm Description

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

Outcomes

Primary Outcome Measures

Relapse-free recurrence

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

Secondary Outcome Measures

Relapse-free survival

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

Full Information

NCT ID

NCT02739204

First Posted

March 22, 2016

Last Updated

April 11, 2016

Sponsor

China Medical University Hospital

Collaborators

Ministry of Health and Welfare, Taiwan

1. Study Identification

Unique Protocol Identification Number

NCT02739204

Brief Title

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

Official Title

Development of Novel Diagnostic Tools and Therapeutic Strategies for Oral Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

April 2016

Overall Recruitment Status

Unknown status

Study Start Date

November 2013 (undefined)

Primary Completion Date

December 2016 (Anticipated)

Study Completion Date

December 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

China Medical University Hospital

Collaborators

Ministry of Health and Welfare, Taiwan

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Oral Squamous Cell Carcinoma

Keywords

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

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

270 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Celecoxib

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Celecoxib

Other Intervention Name(s)

Celebrex

Intervention Description

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

Primary Outcome Measure Information:

Title

Relapse-free recurrence

Description

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

Time Frame

3 year relapse-free recurrence

Secondary Outcome Measure Information:

Title

Relapse-free survival

Description

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

Time Frame

3 year relapse-free survival

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: Pregnant women paitents Taiwanese aboriginal patients Not primary OSCC patients OSCC patients with dysfunction of liver and/or kidneys

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Ying-Chin Ko, MD-PhD

Phone

886-4-22052121

Ext

7322

ycko0406@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ying-Chin Ko, MD-PhD

Organizational Affiliation

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

Official's Role

Study Chair

Facility Information:

Facility Name

Department of Otolaryngology

City

Taichung

ZIP/Postal Code

40447

Country

Taiwan

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

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

Phone

886-4-22052121

Ext

4436

minghsui@mail.cmuh.org.tw

First Name & Middle Initial & Last Name & Degree

Chun-Hung Hua, M.D.

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Learn more about this trial

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

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