UMIN-CTR Clinical Trial

Public title

The safety trial of sonodynamic therapy for unresectable intractable cancer

Acronym

Sonodynamic therapy for unresectable intractable cancer

Scientific Title

The safety trial of sonodynamic therapy for unresectable intractable cancer

Scientific Title:Acronym

Sonodynamic therapy for unresectable intractable cancer

Region

Japan

Condition

unresectable intractable cancer

Classification by specialty

Hepato-biliary-pancreatic medicine

Classification by malignancy

Malignancy

Genomic information

NO

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

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

Study type

Interventional

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

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

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

Name of lead principal investigator

1st name
Middle name
Last name	Atsushi Sofuni

Organization

Tokyo Medical University

Division name

gastroenterology and hepatology

Zip code

Address

6-7-1 Nishishinjuku Shinjuku-ku 160-0023 Tokyo Japan

TEL

03-3342-6111

Email

a-sofuni@amy.hi-ho.ne.jp

Name of contact person

1st name
Middle name
Last name	Atsushi Sofuni

Organization

Tokyo Medical University

Division name

gastroenterology and hepatology

Zip code

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

Institute

Tokyo Medical University

Institute

Department

Personal name

Organization

Japan Agency for Medical Research and Development

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Co-sponsor

Tokyo woman's medical university, Institute of advanced biomedical engineering and science, Faculty of advanced techno-surgery

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

東京医科大学病院（東京都）Tokyo Medical University Hospital (Tokyo)

Date of disclosure of the study information

2017

Year

05

Month

10

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Open public recruiting

Date of protocol fixation

2017

Year

04

Month

03

Day

Date of IRB

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

Other related information

Registered date

2017

Year

05

Month

09

Day

Last modified on

2017

Year

05

Month

09

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031252