Unique ID issued by UMIN | UMIN000007871 |
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Receipt number | 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 11:25:34 |
An exploratory study of chemotherapy enhancement effects of mefenamic acid and cilostazol in patients with locally advanced head & neck cancer
Exploratory study of chemotherapy enhancement effects of mefenamic acid and cilostazol
An exploratory study of chemotherapy enhancement effects of mefenamic acid and cilostazol in patients with locally advanced head & neck cancer
Exploratory study of chemotherapy enhancement effects of mefenamic acid and cilostazol
Japan |
locally advanced head & neck cancer
Hematology and clinical oncology |
Malignancy
NO
To evaluate chemotherapy enhancement effects of mefenamic acid and cilostazol in patients with locally advanced head & neck cancer
Efficacy
Exploratory
Explanatory
Phase II
Response rate
overall survival time, progression-free survival time, and incidences of adverse events
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
YES
NO
Institution is not considered as adjustment factor.
NO
Central registration
3
Treatment
Medicine |
Control arm: S-1 40mg po, twice daily, days 1-14; and cisplatin 70mg/m2 div, day 8, every 4 weeks for 2 cycles
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
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
20 | years-old | <= |
Not applicable |
Male and Female
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
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
120
1st name | |
Middle name | |
Last name | Yuichi Takiguchi |
Graduate School of Medicine, Chiba University
Department of Medical Oncology
Inohana 1-8-1, Chuo-ku, Chiba 260-8670 Japan
043-222-7171
takiguchi@faculty.chiba-u.jp
1st name | |
Middle name | |
Last name | Yuichi Takiguchi |
Graduate School of Medicine, Chiba University
Department of Medical Oncology
Inohana 1-8-1, Chuo-ku, Chiba 260-8670 Japan
043-222-7171
takiguchi@faculty.chiba-u.jp
Chiba University Hospital
Chiba University
Other
Japan
NO
千葉大学医学部附属病院
Chiba University Hospital
2012 | Year | 05 | Month | 01 | Day |
Unpublished
Terminated
2012 | Year | 03 | Month | 29 | Day |
2012 | Year | 05 | Month | 01 | Day |
2014 | Year | 03 | Month | 01 | Day |
2012 | Year | 05 | Month | 01 | Day |
2019 | Year | 01 | Month | 30 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009228
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