UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase I/II study of intravenous and intraperitoneal paclitaxel for peritoneal metastasis after resection of pancreatic cancer refractory to gemcitabine and fluoropyrimidine chemotherapy
Title of the study (Brief title)	Intravenous and intraperitoneal paclitaxel for peritoneal metastasis after resection of pancreatic cancer
Region	Japan

Condition
Condition	Peritoneal metastasis after resection of pancreatic cancer refractory to gemcitabine and fluoropyrimidine chemotherapy
Classification by specialty	Hepato-biliary-pancreatic surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To investigate the safety and efficacy of intravenous and intraperitoneal paclitaxel for peritoneal metastasis after resection of pancreatic cancer refractory to gemcitabine and fluoropyrimidine chemotherapy
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Phase-I: Dose limiting toxicity Phase-II: 2-year 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	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	intravenous and intraperitoneal paclitaxel
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	Peritoneal recurrence after resection of pancreatic cancer, refractory to gemcitabine and fluoropyrimidine chemotherapy, performance status 0 or 1, adequate bone marrow function, adequate liver function, adequate renal function, obtained informed consent
Key exclusion criteria	Metastasis to other distant organsuch as the liver, lungs or bone; other active concomitant malignancies; other severe medical conditions; contraindication of Paclitaxel, Pregnant woman, no informed consent
Target sample size	35

Research contact person
Name of lead principal investigator	Yasuhiro Kodera
Organization	Nagoya University Graduate School of Medicine
Division name	Department of Gastroenterological Surgery (Surgery II)
Address	65,Tsurumai-cho,Showa-ku,Nagoya,Aichi,Tsurumai-cho,Showa-ku,Nagoya,Aichi
TEL	052-744-2245
Email	fjt@med.nagoya-u.ac.jp

Public contact
Name of contact person	Tsutomu Fujii
Organization	Nagoya University Graduate School of Medicine
Division name	Department of Gastroenterological Surgery (Surgery II)
Address	65,Tsurumai-cho,Showa-ku,Nagoya,Aichi
TEL	052-744-2245
Homepage URL
Email	fjt@med.nagoya-u.ac.jp

Sponsor
Institute	Department of Gastroenterological Surgery (Surgery II), Nagoya University Graduate School of Medicine
Institute
Department

Funding Source
Organization	Nagoya University Graduate School of Medicine
Organization
Division
Category of Funding Organization	Other
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 04 Month 01 Day

Progress
Recruitment status	Main results already published
Date of protocol fixation	2015 Year 04 Month 01 Day
Anticipated trial start date	2015 Year 05 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 03 Month 01 Day
Last modified on	2018 Year 07 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019346