UMIN-CTR Clinical Trial

Basic information
Public title	Clinical effect of everolimus and somatostatin analogues as a first line therapy for patients with pNET (phase II study)
Acronym	Clinical effect of everolimus and somatostatin analogues for patients with pNET
Scientific Title	Clinical effect of everolimus and somatostatin analogues as a first line therapy for patients with pNET (phase II study)
Scientific Title:Acronym	Clinical effect of everolimus and somatostatin analogues for patients with pNET
Region	Japan

Condition
Condition	Patients with unresectable or metastatic pNET
Classification by specialty	Hepato-biliary-pancreatic surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To investigate clinical efficacy and sefety of evelolimus and somatostatin analogue for patients with unresectabel pNET
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	progression free survival
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	Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Combined therapy of evelrolimus and somatostatin analogue
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1.pathologically proved NET 2.unresectable disease 3.no prior therapy 4.ECOG performance status 0-2 5.target lesion on RECIST 6.Adequate organ function 7.Written informed consent
Key exclusion criteria	1.past history of allergy for everolimus or somatostatin analogue 2.inaduquate organ function 3.steroids or immunosuppressive thrapy 4.Pregnant females, possibly pregnant females
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Middle name Last name Sohei SATOI
Organization	Kansai Medical University
Division name	Department of Surgery
Zip code
Address	2-3-1 Shinmachi, Hirakata, Osaka
TEL
Email

Public contact
Name of contact person	1st name Middle name Last name
Organization	Kansai Medical University
Division name	Department of Surgery
Zip code
Address
TEL
Homepage URL
Email	satoi@hirakata.kmu.ac.jp

Sponsor
Institute	Kansai Medical University
Institute
Department

Funding Source
Organization	Department of Surgery, Kansai Medical University
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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	2013 Year 04 Month 08 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	Terminated
Date of protocol fixation	2013 Year 04 Month 01 Day
Date of IRB	2013 Year 04 Month 01 Day
Anticipated trial start date	2013 Year 04 Month 08 Day
Last follow-up date	2019 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2013 Year 04 Month 02 Day
Last modified on	2019 Year 10 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000012160