UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000025828
Receipt number R000029701
Scientific Title Photodynamic therapy by laserphyrin and semi-conductor laser in multidisciplinary treatment for unresectable bile duct carcinoma;safety and efficacy
Date of disclosure of the study information 2017/02/01
Last modified on 2019/04/05 13:02:02

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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

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

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 or person

Institute

University of Miyazaki Faculty of Medicine

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029701


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name