UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	An exploratory study of chemotherapy enhancement effects of mefenamic acid and cilostazol in patients with locally advanced head & neck cancer
Title of the study (Brief title)	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	Yuichi Takiguchi
Organization	Graduate School of Medicine, Chiba University
Division name	Department of Medical Oncology
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	Yuichi Takiguchi
Organization	Graduate School of Medicine, Chiba University
Division name	Department of Medical Oncology
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)

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

Progress
Recruitment status	Terminated
Date of protocol fixation	2012 Year 03 Month 29 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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