UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase I trial of adjuvant chemotherapy with modified S-1 and propagermanium for pancreatic cancer
Title of the study (Brief title)	Phase I trial of adjuvant chemotherapy with modified S-1 and propagermanium for pancreatic cancer
Region	Japan

Condition
Condition	pancreatic cancer
Classification by specialty	Hepato-biliary-pancreatic surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	to assess the safety of S-1 adjuvant therapy with propagermanium in patients with resected pancreatic cancer
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase I

Assessment
Primary outcomes	safety
Key secondary outcomes

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	TS-1 <1.25m2, 80mg/body 1.25m2<and<1.5m2, 100mg/body 1.5m2<, 120mg/body day1-28, q2w, x6 propagerumanium 30mg/day day1-28, q2w, x6
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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1)Histologically proven pancreatic adenocarcinoma 2)Gross complete resection (R0) 3)Age above 20 years 4)Status of 0 or 1 5)Adequate hematologic, hepatic and renal function 6)Good oral intake 7)Start therapy after operation within 4 weeks later and 12 weeks 8)Written informed consent
Key exclusion criteria	1)Non curative operation 2)Active concomitant malignancy 3)History of severe anaphylaxies 4)Severe complications, such as heart failure, renal failure, liver failure, watery diarrhea, paresis of intestine, ileus and severe diabetes mellitus 5)With the jaundice or cirrhosis 6)Active infection 7)Pregnant or pregnant possibility 8)Severe mental disorder 9)Inappropriate
Target sample size	10

Research contact person
Name of lead principal investigator	Hidetoshi Eguchi
Organization	Osaka University Hospital
Division name	Division of HBP surgery and Transplantation
Address	2-2 Yamadaoka E-2, Suita, Osaka
TEL	06-6879-3251
Email	heguchi@gesurg.med.osaka-u.ac.jp

Public contact
Name of contact person	Daisaku Yamada
Organization	Osaka University Hospital
Division name	Division of HBP surgery and Transplantation
Address	2-2 Yamadaoka E-2, Suita, Osaka
TEL	06-6879-3251
Homepage URL
Email	dyamada@gesurg.med.osaka-u.ac.jp

Sponsor
Institute	Osaka University Hospital
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Self funding
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	2015 Year 07 Month 01 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2015 Year 05 Month 08 Day
Anticipated trial start date	2015 Year 07 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 05 Month 28 Day
Last modified on	2016 Year 06 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000020523