UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018878 |
|---|---|
| Receipt number | R000021832 |
| Scientific Title | Phase I/II study of Gemcitabine plus nab-paclitaxel and intraperitoneal paclitaxel for pancreas cancer with peritoneal metastasis |
| Date of disclosure of the study information | 2015/09/01 |
| Last modified on | 2019/04/01 18:21:59 |
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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
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
satoi@hirakata.kmu.ac.jp
Public contact
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
satoi@hirakata.kmu.ac.jp
Sponsor or person
Institute
Study group of pancreatic cancer with peritoneal metastasis
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021832
