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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000007871
Receipt No. R000009228
Scientific Title An exploratory study of chemotherapy enhancement effects of mefenamic acid and cilostazol in patients with locally advanced head & neck cancer
Date of disclosure of the study information 2012/05/01
Last modified on 2019/01/30

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Basic information
Public title An exploratory study of chemotherapy enhancement effects of mefenamic acid and cilostazol in patients with locally advanced head & neck cancer
Acronym Exploratory study of chemotherapy enhancement effects of mefenamic acid and cilostazol
Scientific Title An exploratory study of chemotherapy enhancement effects of mefenamic acid and cilostazol in patients with locally advanced head & neck cancer
Scientific Title:Acronym Exploratory study of chemotherapy enhancement effects of mefenamic acid and cilostazol
Region
Japan

Condition
Condition locally advanced head & neck cancer
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate chemotherapy enhancement effects of mefenamic acid and cilostazol in patients with locally advanced head & neck cancer
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Phase II

Assessment
Primary outcomes Response rate
Key secondary outcomes overall survival time, progression-free survival time, and incidences of adverse events

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Control arm: S-1 40mg po, twice daily, days 1-14; and cisplatin 70mg/m2 div, day 8, every 4 weeks for 2 cycles
Interventions/Control_2 Mefenamic acid arm: S-1 40mg po, twice daily, days 1-14; cisplatin 70mg/m2 div, day 8; and Mefenamic acid 750mg daily in 3 divided portions every 4 weeks for 2 cycles
Interventions/Control_3 Cilostazol arm: S-1 40mg po, twice daily, days 1-14; cisplatin 70mg/m2 div, day 8; and Cilostazol 200mg daily in 2 divided portions every 4 weeks for 2 cycles
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) Head and neck cancer
2) Squamous cell carcinoma confirmed by histological examination of the primary tumor
3) Biopsy specimen of the primary tumor available
4) Having a measuable disease
5) Resectable locally advanced disease for which induction chemotherapy is indicated
6) No indication of radiotherapy
7) Aadequate organ function
8) Age (years old): 20 or older
9) written informed consent
Key exclusion criteria 1) Gastric ulcer
2) Severe hematological, hepatic, renal or cardiac disorder
3) History of severe hypersensitivity to the ingredients of an agent used in this study
4) Aspirin asthma or its history
5) Uncontrolled hypertension
6) History of diarrhea in the use of mefenamic acid or cilostazol
7) Receiving anticoagulant therapy
8) Bleeding or bleeding tendency
9) Congestive heart failure
10) Pregnant
11) Lactating women
12) Psychotic disorder
13) Receiving systemic steroid therapy
14) Patients with any other conditions whom the doctor determined to be inappropriate for this study
Target sample size 120

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yuichi Takiguchi
Organization Graduate School of Medicine, Chiba University
Division name Department of Medical Oncology
Zip code
Address Inohana 1-8-1, Chuo-ku, Chiba 260-8670 Japan
TEL 043-222-7171
Email takiguchi@faculty.chiba-u.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yuichi Takiguchi
Organization Graduate School of Medicine, Chiba University
Division name Department of Medical Oncology
Zip code
Address Inohana 1-8-1, Chuo-ku, Chiba 260-8670 Japan
TEL 043-222-7171
Homepage URL
Email takiguchi@faculty.chiba-u.jp

Sponsor
Institute Chiba University Hospital
Institute
Department

Funding Source
Organization Chiba University
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 千葉大学医学部附属病院
Chiba University Hospital

Other administrative information
Date of disclosure of the study information
2012 Year 05 Month 01 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Terminated
Date of protocol fixation
2012 Year 03 Month 29 Day
Date of IRB
Anticipated trial start date
2012 Year 05 Month 01 Day
Last follow-up date
2014 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2012 Year 05 Month 01 Day
Last modified on
2019 Year 01 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009228

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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