UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	safety and efficacy of chemotherapy combined with radiotherapy for maxillary sinus carcinomas
Title of the study (Brief title)	chemotherapy combined with radiotherapy for maxillary sinus carcinomas
Region	Japan

Condition
Condition	maxxillary sinus carcinoma
Classification by specialty	Oto-rhino-laryngology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate safety and efficacy of systemic and superselective intraarterial infusion chemotherapy combined with radiotherapy
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	safety
Key secondary outcomes	efficacy

Base
Study type	Interventional

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

Intervention
No. of arms	1
Purpose of intervention	Diagnosis
Type of intervention	Medicine Maneuver
Interventions/Control_1	systemic chemoterapy(two cycles,first and fifth week, 5 days ,5FU 800mg/mm3) superselective intraarterial infusion chemotherapy(three cycles CDDP) radiation therapy(50Gy)
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	75 years-old >
Gender	Male and Female
Key inclusion criteria	1) maxillary sinus carcinoma 2) enhanced CT 3) squamous cell carcinoma 4) performance status:0 or 1 5) WBC 3000/mm3 or more Platelets 80000/mm3 or more 6) creatinine clearance 60ml/minute or more
Key exclusion criteria	1) distant metastasis 2) stenosis or sclerosis of carotid artery 3) 75 years old over
Target sample size	10

Research contact person
Name of lead principal investigator	Kazuya Otsu
Organization	Mie University Graduate School of Medicine
Division name	Department of Otorhinolaryngology-head and neck surgery
Address	2-174,Edobashi,Tsu,Mie,514-8507 Japan
TEL	059-232-1111
Email	otsu3mk@nifty.com

Public contact
Name of contact person	Kazuya Otsu
Organization	Mie University Graduate School of Medicine
Division name	Department of Otorhinolaryngology-head and neck surgery
Address	2-174,Edobashi,Tsu,Mie,514-8507 Japan
TEL	059-232-1111
Homepage URL
Email	otsu3mk@nifty.com

Sponsor
Institute	Mie University Graduate School of Medicine,Department of Otorhinolaryngology-head and neck surgery
Institute
Department

Funding Source
Organization	Mie University Graduate School of Medicine,Department of Otorhinolaryngology-head and neck surgery
Organization
Division
Category of Funding Organization	Other
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	2009 Year 06 Month 29 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2009 Year 06 Month 01 Day
Anticipated trial start date	2009 Year 06 Month 01 Day
Last follow-up date	2013 Year 12 Month 01 Day
Date of closure to data entry	2018 Year 09 Month 15 Day
Date trial data considered complete	2018 Year 09 Month 15 Day
Date analysis concluded	2018 Year 09 Month 15 Day

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

Management information
Registered date	2009 Year 06 Month 28 Day
Last modified on	2018 Year 09 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000002604