UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029734 |
|---|---|
| Receipt number | R000033970 |
| Scientific Title | Photodynamic diagnosis (PDD) by using Talaporfin and Sie-P2 against local failure after chemoradiotherapy or radiotherapy for esophageal cancer |
| Date of disclosure of the study information | 2017/10/27 |
| Last modified on | 2019/10/30 18:46:50 |
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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
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
hkataoka@med.nagoya-cu.ac.jp
Sponsor or person
Institute
Nagoya City University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033970
