UMIN-CTR Clinical Trial

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
Institute	Kameda Medical Center
Institute
Department

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028013