NCT02739204

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
270

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Nov 2013

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2013

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

March 22, 2016

Completed
24 days until next milestone

First Posted

Study publicly available on registry

April 15, 2016

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

April 15, 2016

Status Verified

April 1, 2016

Enrollment Period

3.1 years

First QC Date

March 22, 2016

Last Update Submit

April 11, 2016

Conditions

Oral Squamous Cell Carcinoma

Keywords

CelecoxibRelapse-free OSCC patientRecurrenceSurvivalPrognosis

Outcome Measures

Primary Outcomes (1)

  • Relapse-free recurrence

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

    3 year relapse-free recurrence

Secondary Outcomes (1)

  • Relapse-free survival

    3 year relapse-free survival

Study Arms (1)

Celecoxib

EXPERIMENTAL

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

Drug: Celecoxib

Interventions

CelecoxibDRUG

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

Also known as: Celebrex
Celecoxib

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Otolaryngology

Taichung, 40447, Taiwan

RECRUITING

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and NeckRecurrence

Interventions

Celecoxib

Condition Hierarchy (Ancestors)

Carcinoma, Squamous CellCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsHead and Neck NeoplasmsNeoplasms by SiteDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

BenzenesulfonamidesSulfonamidesAmidesOrganic ChemicalsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsSulfonesSulfur CompoundsPyrazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Ying-Chin Ko, MD-PhD

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

    STUDY CHAIR

Central Study Contacts

Ying-Chin Ko, MD-PhD

CONTACT

886-4-22052121ycko0406@gmail.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 22, 2016

First Posted

April 15, 2016

Study Start

November 1, 2013

Primary Completion

December 1, 2016

Study Completion

December 1, 2017

Last Updated

April 15, 2016

Record last verified: 2016-04

Locations

TW(1)