UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000024322
Receipt number R000028013
Scientific Title Prospective study of safety and usefulness of transcatheter arterial chemo- embolization by miriplatin and lipiodol for thoracic malignant tumors
Date of disclosure of the study information 2016/10/11
Last modified on 2019/10/02 11:26:51

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Basic information

Public title

Prospective study of safety and usefulness of transcatheter arterial chemo- embolization by miriplatin and lipiodol for thoracic malignant tumors

Acronym

Transcatheter arterial chemo- embolization by miriplatin and lipiodol for thoracic malignant tumors

Scientific Title

Prospective study of safety and usefulness of transcatheter arterial chemo- embolization by miriplatin and lipiodol for thoracic malignant tumors

Scientific Title:Acronym

Transcatheter arterial chemo- embolization by miriplatin and lipiodol for thoracic malignant tumors

Region

Japan


Condition

Condition

Thoracic malignant tumors

Classification by specialty

Pneumology Hematology and clinical oncology Chest surgery
Adult Child

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

The purpose is to examine the tumor response rate and safety of arterial infusion of miriplatin and lipiodol for thoracic malignant tumors, which are difficult to treat by surgery, radiationtherapy, and general chemotherapy.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Explanatory

Developmental phase

Phase II


Assessment

Primary outcomes

Tumor response rate and complications

Key secondary outcomes

Local control period and overall survival


Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


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

10 years-old <=

Age-upper limit

100 years-old >

Gender

Male and Female

Key inclusion criteria

1. Thoracic malignant tumros which can be treated by transcatheter arterial chemo- embolization.
2. The patients who are difficult to be treated by surgery, radiotherapy, and chemotherapy.
3. The patients who are not expected by transcatheter arterial embolization.
4. The patients who meet all of those condisitons.
Or the operable patients who are judged to be better treated by transcatheter arterial chemo-embolization for decreasing tumors before surgery

Key exclusion criteria

1. The patients without inclusion criteria.
2. The patients with allergy for blood vessel contrast medium.
3. The patients with renal failure.
4. The patients who are judged to be unsuitable by doctors.

Target sample size

30


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hiroaki Nomori

Organization

Kameda Medical Center

Division name

Thoracic surgery

Zip code


Address

929 Higashicho, Kamogawa CIty, Chiba

TEL

0470-92-2211

Email

hnomori@qk9.so-net.ne.jp


Public contact

Name of contact person

1st name
Middle name
Last name Hiroaki Nomori

Organization

Kameda Medical Center

Division name

Thoracic surgery

Zip code


Address

929 Higashicho, Kamogawa CIty, Chiba

TEL

0470-92-2211

Homepage URL


Email

hnomori@qk9.so-net.ne.jp


Sponsor or person

Institute

Kameda Medical Center

Institute

Department

Personal name



Funding Source

Organization

None of the research fund

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



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

2016 Year 10 Month 11 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

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



Progress

Recruitment status

Completed

Date of protocol fixation

2016 Year 10 Month 06 Day

Date of IRB

2016 Year 06 Month 01 Day

Anticipated trial start date

2016 Year 10 Month 11 Day

Last follow-up date

2019 Year 12 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

There is no other informations.


Management information

Registered date

2016 Year 10 Month 06 Day

Last modified on

2019 Year 10 Month 02 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028013


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name