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
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
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
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
