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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000027229
Receipt No. R000031196
Scientific Title Phase III study of S-1 plus intravenous and introperitoneal paclitaxel for pancreatic ductal adenocarcinoma patients with peritoneal metastasis
Date of disclosure of the study information 2017/09/01
Last modified on 2017/05/02

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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
Middle name
Last name Sohei SATOI MD, FACS
Organization Knasai Medical University
Division name Department of Surgery
Zip code
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
Middle name
Last name Tomohisa Yamamoto MD
Organization Knasai Medical University
Division name Department of Surgery
Zip code
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 Japan Agency for Medical Research and Develoment
Organization
Division
Category of Funding Organization Japanese Governmental office
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
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 Preinitiation
Date of protocol fixation
2017 Year 01 Month 05 Day
Date of IRB
Anticipated trial start date
2017 Year 09 Month 01 Day
Last follow-up date
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
2017 Year 05 Month 02 Day


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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