UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027229 |
|---|---|
| Receipt number | 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 | 2020/02/27 14:30:13 |
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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 | 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
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
tomot1226@yahoo.co.jp
Sponsor or person
Institute
Study group of pancreatic cancer with
peritoneal metastasis
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031196
