UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021501 |
|---|---|
| Receipt number | R000024797 |
| Scientific Title | Clinical study of photodynamic therapy for peripheral typelung cancers |
| Date of disclosure of the study information | 2016/03/16 |
| Last modified on | 2018/03/18 11:09:10 |
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Basic information
Public title
Clinical study of photodynamic therapy for peripheral typelung cancers
Acronym
Clinical study of photodynamic therapy for peripheral typelung cancers
Scientific Title
Clinical study of photodynamic therapy for peripheral typelung cancers
Scientific Title:Acronym
Clinical study of photodynamic therapy for peripheral typelung cancers
Region
| Japan |
Condition
Condition
Lung Cancer
Classification by specialty
| Pneumology | Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To study the safety and efficacy of Photodynamic therapy for periferal lung cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
frequency of adverse event of grade 2 or more within 90 days of PDT
Key secondary outcomes
Recurrence free survival rate at 90days and 1 year after PDT
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
| Device,equipment | Maneuver |
Interventions/Control_1
Photodynamic theapy
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
Cancer nodule within 20mm in maximum measured by thin-slice CT
Negative for lymphnode or distant metastasis measured by FDG-PET, abdomnal CT or US, Brain CT or MRI.
ECOG PS 0-2
Over 20 years old
Platete: 100000~400000
PT-INR: less than 1.4
Diagnosed as non-small cell lung cancer by trans-bronchal biopsy or cytology
Inoperable case or Reject operation cases
with written informed concent
Key exclusion criteria
Patients with anti-coagulant dose, except for salicylic acid formulation in the past week
women who are/may pregnant, or lactating
Patients with serious complications such as heart disease, liver disease and kidney failure
Patients who have the porphyria
Patients who have the sunlight hypersensitivity
Patients who have been determined to be inappropriate as a subject upon the doctor's discretion
Target sample size
6
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Jitsuo Usuda |
Organization
Nippon Medical School Hospital
Division name
Thoracic Surgery
Zip code
Address
1 Chome-1-5 Sendagi Bunkyo-ku, Tokyo
TEL
03-3822-2131
jusuda@nms.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Jitsuo Usuda |
Organization
Nippon Medical School Hospital
Division name
Thoracic Surgery
Zip code
Address
1 Chome-1-5 Sendagi Bunkyo-ku, Tokyo
TEL
03-3822-2131
Homepage URL
jusuda@nms.ac.jp
Sponsor or person
Institute
Nippon Medical School Hospital
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development (AMED)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2016 | Year | 03 | Month | 16 | 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
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 | 02 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 03 | Month | 16 | Day |
Last follow-up date
| 2018 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
| 2018 | Year | 04 | Month | 30 | Day |
Date trial data considered complete
Date analysis concluded
| 2018 | Year | 04 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 03 | Month | 16 | Day |
Last modified on
| 2018 | Year | 03 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024797
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
