UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The safety trial of sonodynamic therapy for unresectable intractable cancer
Title of the study (Brief title)	Sonodynamic therapy for unresectable intractable cancer
Region	Japan

Condition
Condition	unresectable intractable cancer
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the safety of sonodynamic therapy (SDT), which combined high-intensity focused untrasound (HIFU) therapy and chemotherapy (epirubicin-conjugated polymer micelles), and evaluate maximum tolerated dose (MTD) of SDT.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase I

Assessment
Primary outcomes	The safety of SDT during SDT and for 1 week and 1 month after SDT
Key secondary outcomes	the anti-tumor effect and the symptom relief effect for 2 months after SDT

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine Device,equipment
Interventions/Control_1	Epirubicin-conjugated polymer micelles (NC-6300) will be administer intravenously within10 minutes before 24 hours of HIFU therapy. The protocol of the 1st and a secondary steppe are NC-6300:80 mg/m2 and HIFU radiations (MS2:75W or150W), and the third and the fourth steppe are NC-6300:30 mg/m2 and HIFU radiation (MS2:75W or150W). The protocol will be perform once.
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.The patients diagnosed as the intractable cancer, pancreatic cancer, biliary tract cancer, osteoncus involved metastatic cancer, and the patients who the US visualization is possible, and the therapy for a so far was not adapted, or effective. Those who understood the purpose and the significance of this work to the sufficiently, and have agreed with the document. 2.The patients whom a subject lesion can evaluate by US and CT (or MRI) 3.The patients who can secure the route of focussing of ultrasonic waves 4.Male and female, the age is more than 20, less than 75 years old 5.The patients by whom principal viscus functionalists (heart, liver, lung, kidney etc) are held 6.Fulfill all the following conditions, all characteristics to be inspected should be carried out within two weeks before the registration neutrophilics more than 1500/mm3, platelet more than 10000/mm30, hgb more than 9.0g/dl, Cr less than 1.5mg/dl, AST less than 120IU/l, ALT less than 120IU/l, T-Bil less than 3mg/dl 7.Performance status of ECOG 0-1 8.The patients who can expect the survive for 12 weeks or more
Key exclusion criteria	1.The patients who has cancer of other organs or is suspected 2.The treatment history of radiotherapy 3.The treatment history of chemotherapy before registration within one month 4.The treatment history of HIFU therapy before registration within two months 5.The patients by whom heomostatic troubles, such as an antiplatelet therapy and an anticoagulation, are expected 6.The patients who has invasion of cancer to stomach and duodenum 7.The patients who has obstructive jaundice (the patients after removing of obstruction is available) 8.The patients by whom tumor adjoins the vena cava inferior and tumor emboli exist in a vena cava inferior (however, good, if the site is avoided) 9.The patients by whom tumor adjoins aorta and a calcified lesion is an exist (however, good, if the site is avoided) to aorta 10.The patients who has cystic lesion in pancreatic cancer 11.The patients of the use history of anthracycline drug 12.The patients who has an anamnestic of a critical drug hypersensitivity 13.The patients who has a radiocontrast-agent allergy 14.The patients who has a critical encephalopathy and pulmonary disease (pneumonitis, pulmonary fibrosis which can be checked on an imaging) 15.The patients who has an anamnestic of congestive heart failure, a symptomatic coronary artery disease, an irregularity of pulse with poor control with medicament, myocardial infarction for less than six months, or unstable angina 16.The patients who has an active infective disease which needs a systemic treatment 17.Pregnant women or the patients who may have become pregnant, and the out-of patient of a contraceptive intention 18.The patients who judged that principal investigator was unsuitable as subject
Target sample size	15

Research contact person
Name of lead principal investigator	Atsushi Sofuni
Organization	Tokyo Medical University
Division name	gastroenterology and hepatology
Address	6-7-1 Nishishinjuku Shinjuku-ku 160-0023 Tokyo Japan
TEL	03-3342-6111
Email	a-sofuni@amy.hi-ho.ne.jp

Public contact
Name of contact person	Atsushi Sofuni
Organization	Tokyo Medical University
Division name	gastroenterology and hepatology
Address	6-7-1 Nishishinjuku Shinjuku-ku 160-0023 Tokyo Japan
TEL	03-3342-6111
Homepage URL
Email	a-sofuni@amy.hi-ho.ne.jp

Sponsor
Institute	Tokyo Medical University
Institute
Department

Funding Source
Organization	Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor	Tokyo woman's medical university, Institute of advanced biomedical engineering and science, Faculty of advanced techno-surgery
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	東京医科大学病院（東京都）Tokyo Medical University Hospital (Tokyo)

Other administrative information
Date of disclosure of the study information	2017 Year 05 Month 10 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2017 Year 04 Month 03 Day
Anticipated trial start date	2017 Year 05 Month 10 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	2017 Year 05 Month 09 Day
Last modified on	2017 Year 05 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031252