UMIN-CTR Clinical Trial

Basic information
Public title	Photodynamic diagnosis (PDD) by using Talaporfin and Sie-P2 against local failure after chemoradiotherapy or radiotherapy for esophageal cancer
Acronym	Photodynamic diagnosis (PDD) by using Talaporfin and Sie-P2
Scientific Title	Photodynamic diagnosis (PDD) by using Talaporfin and Sie-P2 against local failure after chemoradiotherapy or radiotherapy for esophageal cancer
Scientific Title:Acronym	Photodynamic diagnosis (PDD) by using Talaporfin and Sie-P2
Region	Japan

Condition
Condition	esophageal cancer
Classification by specialty	Medicine in general Gastroenterology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Photodymanic diagnosis against esophageal cancer by using Talaporfin and Sie-P2.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Phase I

Assessment
Primary outcomes	Safety and efficacy of PDD
Key secondary outcomes

Base
Study type	Interventional

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

Intervention
No. of arms	1
Purpose of intervention	Diagnosis
Type of intervention	Medicine Device,equipment
Interventions/Control_1	PDD
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	Not applicable
Gender	Male and Female
Key inclusion criteria	1.The patient of recurrent esopphageal cacner after CRT who will be trated by Photodynamic therapy(PDT) with Talaporfin. Local failure after CRT or RT:more than 50Gy 2.histologically proven local failure 3.either not candidates for salvage surgery or having a physical status that would make the surgery intolerable 4.lesions limited to within the muscularis propria 5.age more than 20 years old 6.the patient who has no disturbance in liver and kidney. 7.provision of written informed consent
Key exclusion criteria	1. the patinet who can not be inserted endoscope 2. with malignant hypertension, conjestive heart failure, liver dysfunction, myocardil infarction within 3 months, endostage of liver cirrhosis, poor controled DM, severe lung fibrosis, active pneumonitis 3. with active infection 4. inability to comply the sun shade restrictions 5. porphyria 6. severe psychosomatic disturbance 7. allergy against Talaporfin 8. for women, pregnancy or lactation, or unwillingness to use contraception 9. T3 or T4 10. larger than 3cm in diameter 11. half the circumference of the lumen or less 12. invasion to the cervical esophagus 13. patients who judged by the investigator that enrollment was inappropriate
Target sample size	10

Research contact person
Name of lead principal investigator	1st name Hiromi Middle name Last name Kataoka
Organization	Nagoya City University Hospital
Division name	Division of Endoscopy
Zip code	467-8601
Address	1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya
TEL	052-851-5511
Email	hkataoka@med.nagoya-cu.ac.jp

Public contact
Name of contact person	1st name Hiromi Middle name Last name Kataoka
Organization	Division of Gastroenterology
Division name	Division of Gastroenterology
Zip code	467-8601
Address	1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya
TEL	052-851-5511
Homepage URL
Email	hkataoka@med.nagoya-cu.ac.jp

Sponsor
Institute	Nagoya City University Hospital
Institute
Department

Funding Source
Organization	nothing
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	Nagoya City University
Address	1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya
Tel	052-851-5511
Email	hkataoka@med.nagoya-cu.ac.jp

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	名古屋市立大学病院（愛知県）

Other administrative information
Date of disclosure of the study information	2017 Year 10 Month 27 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	2
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	Terminated
Date of protocol fixation	2017 Year 10 Month 24 Day
Date of IRB	2018 Year 02 Month 07 Day
Anticipated trial start date	2018 Year 04 Month 07 Day
Last follow-up date	2018 Year 12 Month 04 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2017 Year 10 Month 27 Day
Last modified on	2019 Year 10 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000033970