UMIN-CTR Clinical Trial

Basic information
Public title	Safety and efficacy of photodynamic therapy using ME2906 and PNL6405GST for gastric cancer in patients who cannot undergo surgery or endoscopic resection
Acronym	Safety and efficacy of photodynamic therapy for gastric cancer
Scientific Title	Safety and efficacy of photodynamic therapy using ME2906 and PNL6405GST for gastric cancer in patients who cannot undergo surgery or endoscopic resection
Scientific Title:Acronym	Safety and efficacy of photodynamic therapy for gastric cancer
Region	Japan

Condition
Condition	Gastric cancer
Classification by specialty	Gastroenterology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Safety
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	To decide maximum tolerated dose of irradiation fluence (50, 75 or 100 J/cm2) to evaluate dose limited toxicity
Key secondary outcomes

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 Device,equipment
Interventions/Control_1	Photodynamic therapy
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	(1) Patients with clinical stage IA gastric cancer (2) The size of tumor fulfilled any condition shown below, confirmed by EGD performed within 28 days before the photodynamic therapy (A) The size of tumor was 1-3 centimeter diameter without ulceration (B) The size of tumor was less than 2 centimeter with ulceration (3) The whole tumor can be observed and can be irradiated stably (4) No lymph node metastasis evaluated by CT performed within 28 days before the photodynamic therapy (5) Patients cannot undergo surgery or endoscopic resection (6) Patients whom a written consent can be obtained
Key exclusion criteria	(1) Patients having active multiple cancers except gastric cancer (2) Patients who cannot undergo EGD safely (A) Patients in the shock state (B) Patients with disseminated intravascular coagulation (C) Patients with desaturation (SpO2 < 90%) even under oxygen administration (D) Patients with thrombocytopenia (< 10000 / micro-liter) (E) Performance status 4 (F) Patients with heart failure (NYHA class IV) (G) Patients with angina pectoris (CSS grade IV) (H) Patients with severe valvular disease of heart (I) Patients with pulmonary hypertension (WHO classification group 4) (J) Patients with ventilatory impairment (both FEV1.0% and %VC < 60%) (K) Patients with severe bronchial asthma (L) Patients with coagulopathy (PT-INR > 3.0) (3) Patients who cannot tolerate shading (4) Patients with porphyria (5) Patients with photosensitivity (6) Patients had PDT therapy previously (7) Patients in pregnancy (8) Nursing patients (9) Patients with severe liver failure (Child-Pugh classification class C) (10) Patients enrolling another clinical trial or within 3 months after the completion of enrollment of another clinical trial (11) Patients who were not suitable for the study
Target sample size	18

Research contact person
Name of lead principal investigator	1st name Yasuyuki Middle name Last name Shimoyama
Organization	Gunma University Hospital
Division name	Division of Gastroenterology and Hepatology
Zip code	371-8511
Address	3-39-15 Showa-machi, Maebashi, Gunma, Japan
TEL	027-220-8137
Email	yshimoyama@gunma-u.ac.jp

Public contact
Name of contact person	1st name Shiko Middle name Last name Kuribayashi
Organization	Gunma University Hospital
Division name	Division of Gastroenterology and Hepatology
Zip code	371-8511
Address	3-39-15 Showa-machi, Maebashi, Gunma, Japan
TEL	027-220-8137
Homepage URL
Email	shikokuri@gunma-u.ac.jp

Sponsor
Institute	Gunma University Hospital
Institute
Department

Funding Source
Organization	Gunma University
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	Gunma University Hospital Institutional Review Board
Address	3-39-15 Showa-machi, Maebashi, Gunma, Japan
Tel	027-220-8740
Email	shikokuri@gunma-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	群馬大学医学部附属病院（群馬県）

Other administrative information
Date of disclosure of the study information	2018 Year 05 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
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	2018 Year 02 Month 15 Day
Date of IRB	2018 Year 02 Month 28 Day
Anticipated trial start date	2018 Year 05 Month 01 Day
Last follow-up date	2019 Year 07 Month 24 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 04 Month 26 Day
Last modified on	2022 Year 05 Month 24 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036808