UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032398 |
|---|---|
| Receipt number | R000036808 |
| Scientific Title | Safety and efficacy of photodynamic therapy using ME2906 and PNL6405GST for gastric cancer in patients who cannot undergo surgery or endoscopic resection |
| Date of disclosure of the study information | 2018/05/01 |
| Last modified on | 2022/05/24 21:30:46 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
shikokuri@gunma-u.ac.jp
Sponsor or person
Institute
Gunma University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036808
