UMIN-CTR Clinical Trial

Basic information
Public title	Phase I/II study of Gemcitabine plus nab-paclitaxel and intraperitoneal paclitaxel for pancreas cancer with peritoneal metastasis
Acronym	clinical study for pancreatic cancer with peritoneal metastasis
Scientific Title	Phase I/II study of Gemcitabine plus nab-paclitaxel and intraperitoneal paclitaxel for pancreas cancer with peritoneal metastasis
Scientific Title:Acronym	clinical study for pancreatic cancer with peritoneal metastasis
Region	Japan

Condition
Condition	The patients with pancreatic cancer who have peritoneal metastasis diagnosed by staging laparoscopy or open laparotomy.
Classification by specialty	Hepato-biliary-pancreatic surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To investigate safety and clinical efficacy of Gemcitabine and nab-paclitaxel plus intraperitoneal paclitaxel administration in pancreatic cancer patients with peritoneal metastasis
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	One year survival rate
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
Interventions/Control_1	Gemcitabine (800-1000mg/m2, weekly for 3 weks with 1wk rest) and nab-paclitaxel(100-125mg/m2, weekly for 3 weks with 1wk rest) plus intraperitoneal paclitaxel administration (15-20mg/m2, weekly for 3 weks with 1wk rest) Regimen will be continued according to the protocol.
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	80 years-old >
Gender	Male and Female
Key inclusion criteria	Pancreatic adenocarcinoma histologically proven with peritoneal metastasis diagnosed using staging laparoscopy or open laparotomy, performance status 0 or 1, adequate bone marrow function, adequate liver function, adequate renal function, obtained informed consent
Key exclusion criteria	Metastasis to distant organ sites such as the liver, lungs or bone; other active concomitant malignancies; other severe medical conditions; contraindication of Gemcitabine, nab-paclitaxel or Paclitaxel, or Pregnant woman
Target sample size	48

Research contact person
Last name of lead principal investigator	1st name Middle name Last name Sohei SATOI MD, FACS
Organization	Kansai Medical University
Division name	Department of Surgery
Zip code
Address	2-3-1 Shinmachi, Hirakata, Osaka
TEL	0728040101
Email	satoi@hirakata.kmu.ac.jp

Public contact
1st name of contact person	1st name Middle name Last name Sohei SATOI MD, FACS
Organization	Kansai Medical University
Division name	Department of Surgery
Zip code
Address	2-3-1 Shinmachi, Hirakata, Osaka
TEL	0728040101
Homepage URL
Email	satoi@hirakata.kmu.ac.jp

Sponsor
Institute	Study group of pancreatic cancer with peritoneal metastasis
Institute
Department

Funding Source
Organization	Study group of pancreatic cancer with peritoneal metastasis
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	2015 Year 09 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	2015 Year 04 Month 30 Day
Date of IRB	2015 Year 08 Month 12 Day
Anticipated trial start date	2015 Year 09 Month 01 Day
Last follow-up date	2019 Year 03 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	2015 Year 09 Month 01 Day
Last modified on	2019 Year 04 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021832