UMIN-CTR Clinical Trial

Basic information
Public title	Phase III study of S-1 plus intravenous and introperitoneal paclitaxel for pancreatic ductal adenocarcinoma patients with peritoneal metastasis
Acronym	Phase III study for pancreatic ductal adenocarcinoma patients with peritoneal metastasis
Scientific Title	Phase III study of S-1 plus intravenous and introperitoneal paclitaxel for pancreatic ductal adenocarcinoma patients with peritoneal metastasis
Scientific Title:Acronym	Phase III study for pancreatic ductal adenocarcinoma patients with peritoneal metastasis
Region	Japan

Condition
Condition	pancreatic ductal adenocarcinoma patients with peritoneal metastasis
Classification by specialty	Hepato-biliary-pancreatic surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To investigate clinical efficacy of S-1 plus intravenous and intraperitoneal paclitaxel in pancreatic ductal adenocarcinoma patients with peritoneal metastasis in comparison with overall survival in patients who received gemcitabine and nab-paclitaxel.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Overall survival
Key secondary outcomes	Response rate, rate of negative peritoneal washing cytology, resectability, dose intensity, progression-free survival, rate of alleviating cancer symposium, rate of decreased tumor marker level, safety (adverse event profile etc.) etc.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Cluster
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	S-1 is administered orally twice daily at a dose of 80mg/m2/d for 14 consecutive days, followed by 7 days of rest. PTX is administered i.v. at a dose of 50mg/m2 and i.p. at 20mg/m2 on days 1 and 8.
Interventions/Control_2	Nab-PTX (125mg/m2) and GEM (1000mg/m2)is administered i.v. on days 1, 8, and 15 followed by one week of rest.
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	1.histologically proven pancreatic ductal adenocarcinoma and peritoneal metastasis diagnosed using staging laparoscopy or open laparotomy 2.a chemo-naive patient or a patient within 2 months after introducing the first-line chemotherapy 3.performance status 0 or 1 4.adequate bone marrow, lung, liver amd renal function 5.a patient who can eat by mouth 6.obtained informed consent 7.20 years or more and less than 80 years
Key exclusion criteria	1.Metastasis to distant organ sites such as the liver, lungs, bone and so on except ovary 2.resectable pancreatic ductal adenocarcinoma defined by NCCN guideline with positive peritoneal washing cytology 3.contraindication of S-1 gemcitabine, nab-paclitaxel, and paclitaxel 4. evident infection or inflammation on the entry of the study 5.severe herat disease 6.severe co-morbid diseases 7.highly amount of ascites 8.active intestinal bleeding 9.diarrhea (4 time or more in a day) 10. psychiatric disease 11. other active concomitant malignancies 12. pregnat (probable) or feeding women 13. a patient recognized as inappropriate 14. a petient receiving flucytosine, fenitoin, or warfarin. 15. a patient with allergic reaction to S-1, gemcitabine, nab-paclitaxel and paclitaxel 16. a patient with direct tumor invation to the intestine diagnosed by endoscopy or CT scan 17. a patient who cannot give appropriate informed consent other severe medical conditions; contraindication of Gemcitabine, nabpaclitaxel or Paclitaxel, or Pregnant woman
Target sample size	180

Research contact person
Name of lead principal investigator	1st name Sohei Middle name Last name SATOI
Organization	Knasai Medical University
Division name	Department of Surgery
Zip code	5730101
Address	2-5-1, Shin-machi, Hirakata, Osaka, JAPAN
TEL	072-804-0101
Email	satoi@hriakata.kmu.ac.jp

Public contact
Name of contact person	1st name Tomohisa Middle name Last name Yamamoto
Organization	Knasai Medical University
Division name	Department of Surgery
Zip code	5731010
Address	2-5-1, Shin-machi, Hirakata, Osaka, JAPAN
TEL	072-804-0101
Homepage URL
Email	tomot1226@yahoo.co.jp

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

Funding Source
Organization	cloud funding
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	Wakayama Medical University Certified Review Board
Address	811-1 Kimiidera, Wakayama, Wakayama Prefecture 641-8509, Japan
Tel	073-441-0896
Email	wa-rinri@wakayama-med.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

Other administrative information
Date of disclosure of the study information	2017 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	Open public recruiting
Date of protocol fixation	2017 Year 01 Month 05 Day
Date of IRB	2019 Year 11 Month 19 Day
Anticipated trial start date	2020 Year 02 Month 07 Day
Last follow-up date	2024 Year 05 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	2017 Year 05 Month 02 Day
Last modified on	2020 Year 02 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031196