UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A Phase II clinical trial to evaluate the efficacy and safety of intra-arterial infusion chemotherapy for head and neck squamous cell carcinoma
Title of the study (Brief title)	A Phase II clinical trial of intra-arterial infusion chemotherapy for head and neck SCC
Region	Japan

Condition
Condition	head and neck squamous cell carcinoma
Classification by specialty	Oto-rhino-laryngology Adult
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	This study aims to evaluate the efficacy and safety of intra-arterial infusion chemotherapy for head and squamous cell carcinoma.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Adverse event rate from starting treatment till 6months after end of treatment
Key secondary outcomes	Response rate

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	We plan intra-arterial administrarion of cisplatinum and docetaxel through the catheter which is put in feeding artery of the cancer. cisplatinum:40-100mg/m2/weekly docetaxel:5-15mg/m2/weekly administration period:3-6weeks
Interventions/Control_2
Interventions/Control_3
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	80 years-old >=
Gender	Male and Female
Key inclusion criteria	1. Patients diagnosed with head and neck SCC. 2. ECOG PS of 0-2 3. WBC>3000/ul, Platelet>75000/ul, Creatinine<1.5mg/dL, T-Bil<1.5mg/dL, AST/ALT levels 2.5 times the upper limit of normal 4. Patients agreed this study on document of informed consent.
Key exclusion criteria	1. History of intolerance or hypersensitivity to drugs which will be used or any excipient of the product. 2. Current pregnancy 3. Current known active infection 4. Uncontrolled diabetes 5. Severe heart disease 6. Severe pulmonary disease 7. Patients who are judged to be inappropriate for participation in this study.
Target sample size	40

Research contact person
Name of lead principal investigator	Yoshitaka Okamoto
Organization	Graduate School of Medicine, Chiba University
Division name	Department of Otorhinolaryngology, Head and Neck Surgery
Address	1-8-1 Inohana, Chuo-ku, Chiba city, Chiba, Japan.
TEL	043-222-7171
Email	yokamoto@faculty.chiba-u.jp

Public contact
Name of contact person	Kazuki Yamasaki
Organization	Graduate School of Medicine, Chiba University
Division name	Department of Otorhinolaryngology, Head and Neck Surgery
Address	1-8-1 Inohana, Chuo-ku, Chiba city, Chiba, Japan.
TEL	043-222-7171
Homepage URL
Email	k.yamasaki@faculty.chiba-u.jp

Sponsor
Institute	Department of Otorhinolaryngology, Head and Neck Surgery, Graduate School of Medicine, Chiba University
Institute
Department

Funding Source
Organization	Graduate School of Medicine, Chiba University
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

Other administrative information
Date of disclosure of the study information	2015 Year 11 Month 20 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 01 Month 08 Day
Anticipated trial start date	2013 Year 01 Month 08 Day
Last follow-up date
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	2015 Year 11 Month 19 Day
Last modified on	2019 Year 03 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022947