UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Clinical study of photodynamic therapy for peripheral typelung cancers
Title of the study (Brief title)	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	Jitsuo Usuda
Organization	Nippon Medical School Hospital
Division name	Thoracic Surgery
Address	1 Chome-1-5 Sendagi Bunkyo-ku, Tokyo
TEL	03-3822-2131
Email	jusuda@nms.ac.jp

Public contact
Name of contact person	Jitsuo Usuda
Organization	Nippon Medical School Hospital
Division name	Thoracic Surgery
Address	1 Chome-1-5 Sendagi Bunkyo-ku, Tokyo
TEL	03-3822-2131
Homepage URL
Email	jusuda@nms.ac.jp

Sponsor
Institute	Nippon Medical School Hospital
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 02 Month 17 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000024797