UMIN-CTR Clinical Trial

Basic information
Public title	Photodynamic therapy by laserphyrin and semi-conductor laser in multidisciplinary treatment for unresectable bile duct carcinoma;safety and efficacy
Acronym	Photodynamic therapy for unresectable cholangiocarcinoma
Scientific Title	Photodynamic therapy by laserphyrin and semi-conductor laser in multidisciplinary treatment for unresectable bile duct carcinoma;safety and efficacy
Scientific Title:Acronym	Photodynamic therapy for unresectable cholangiocarcinoma
Region	Japan

Condition
Condition	Unresectable bile duct carcinoma
Classification by specialty	Hepato-biliary-pancreatic medicine Hepato-biliary-pancreatic surgery Adult
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The effective treatment with high-evidence level for local treatment has not been still established in unresectable bile duct carcinoma. Treatment efficacy and improvement of patient survival by the photodynamic therapy (PDT) for unresctable bile duct carcinomas has been reported by the several clinical study in the western series. In the present study, the clinical trials to clarify safety and efficacy of PDT using laserphyrin and semi-conductor laser for unresectable bile duct carcinoma is going to perform.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase I,II

Assessment
Primary outcomes	presence or absence of photosensitivity after treatment of PDT
Key secondary outcomes	Overall survival period, tumor progression-free survival, period until bilairy stent obstruction, tumor response rate, other adverse event, changes of blood concentration of porphyrin, disease-control rate during follow-up after day 56 of PDT treatment

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	Treatment
Type of intervention	Medicine
Interventions/Control_1	Laserphyrin
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	18 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	(1)Cases diagnosed as remarkable bile duct carcinoma by 1) and 2) 1)Typical diagnosis by imaging analysis by ultrasonography, CT, MRI, ERCP etc. 2)Typical diagnosis by tumor biopsy, cytology or postoperative tissue specimens (2)Cases who are expected the improvement of prognosis by local control using other systemic chemotherapy (3)Presence of distant metastasis or node metastasis is not required. (4)Presence of stent treatment at the site of bile duct stenosis by the tumor is not required. (5)At the time of informed consent, patients over 18 years old who are spontaneously acceptable for agreement (6)Patients with performance Status (ECOG) ranged as 0-2, or Karnofsky Performance Index equal to or more than 50 (7)Patients who are relieved the obstructive jaundice(T-Bil less than 5mg/dl) (8)Patients with stable cardiac, pulmonary, hepatic, renal and bone marrow functions as below; a. Renal function;BUN and serum creatine level equal to or less than 1.5 times of the upper limit of institutional normal range b.Hepatic function;AST(GOT) and ALT(GPT) equal less than 100IU/L c. Blood; neutrophil equal to or more than 1,500/mm3, platelet count equal to or more than 100,000/mm3,Hb equal to or more than 8.5g/dl d. Cardiac function; no serious abnormality by ECG e. Lung function;Arterial oxygen concentration(SpO2) equal to or more than 94% (under administration of oxygen) (9)After the enough informed connsent for attempting in the present study, patients who well understand and provide agreement of documents by the patient's spontaneous will
Key exclusion criteria	(1)Patients requiring radiation therapy as a local treatment (2)Patients who cannot receive laser irradiation to the tumor by any reasons (3)Patients with serious co-morbidity(malignant hypertension, severe congestive cardiac failure, severe hepatic failure, cardiac infarction withtin 3 months, terminal stage of cirrhosis, uncontrolled diabetes,severe pulmonary fibrosis, active interstitial peumonitis etc) (4)Patients with uncontrolled infectious diseases including actibe tuberclosis (5)atients who are difficult to limitatehospital stay under dark room (6)Porphyria patients (7)Patients diagnosed as severe mental disorders or dementia (8)Patients who attend other clinical study (9)Patients who are hypersensitive for laserphyrin (10)Female patients with pregnancy, pregnant-suspicious and breast-feeding (11)Unresctable bile duct patients in whom the better prognosis are not expected by the researcher's judgement. (12)Other patients who are not stable for clinical study by the judgement of attendant doctors
Target sample size	25

Research contact person
Last name of lead principal investigator	1st name Atsushi Middle name Last name Nanashima
Organization	University of Miyazaki Faculty of Medicine
Division name	Division of Hepato-biliary-pancreatic Surgery
Zip code	889-1692
Address	5200Kihara, Kiyotake, Miyazaki
TEL	0985-85-2905
Email	a_nanashima@med.miyazaki-u.ac.jp

Public contact
1st name of contact person	1st name Atsushi Middle name Last name Nanashima
Organization	University of Miyazaki Faculty of Medicine
Division name	Division of Hepato-biliary-pancreatic Surgery
Zip code	8891692
Address	Miyazaki
TEL	0985-85-2905
Homepage URL
Email	a_nanashima@med.miyazaki-u.ac.jp

Sponsor
Institute	University of Miyazaki Faculty of Medicine
Institute
Department

Funding Source
Organization	Miyazaki University Hospital
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	University of Miyazaki Faculty of Medicine
Address	5200 Kihara Kiyotake Miyazaki
Tel	0985852905
Email	a_nanashima@med.miyazaki-u.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

Other administrative information
Date of disclosure of the study information	2017 Year 02 Month 01 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	Completed
Date of protocol fixation	2016 Year 05 Month 18 Day
Date of IRB	2016 Year 12 Month 09 Day
Anticipated trial start date	2017 Year 03 Month 17 Day
Last follow-up date	2019 Year 03 Month 26 Day
Date of closure to data entry
Date trial data considered complete	2019 Year 03 Month 26 Day
Date analysis concluded

Other
Other related information

Management information
Registered date	2017 Year 01 Month 24 Day
Last modified on	2019 Year 04 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029701