UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016670 |
|---|---|
| Receipt number | R000019346 |
| Scientific Title | Phase I/II study of intravenous and intraperitoneal paclitaxel for peritoneal metastasis after resection of pancreatic cancer refractory to gemcitabine and fluoropyrimidine chemotherapy |
| Date of disclosure of the study information | 2015/04/01 |
| Last modified on | 2018/07/25 14:52:44 |
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Basic information
Public title
Phase I/II study of intravenous and intraperitoneal paclitaxel for peritoneal metastasis after resection of pancreatic cancer refractory to gemcitabine and fluoropyrimidine chemotherapy
Acronym
Intravenous and intraperitoneal paclitaxel for peritoneal metastasis after resection of pancreatic cancer
Scientific Title
Phase I/II study of intravenous and intraperitoneal paclitaxel for peritoneal metastasis after resection of pancreatic cancer refractory to gemcitabine and fluoropyrimidine chemotherapy
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Yasuhiro Kodera |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Gastroenterological Surgery (Surgery II)
Zip code
Address
65,Tsurumai-cho,Showa-ku,Nagoya,Aichi,Tsurumai-cho,Showa-ku,Nagoya,Aichi
TEL
052-744-2245
fjt@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tsutomu Fujii |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Gastroenterological Surgery (Surgery II)
Zip code
Address
65,Tsurumai-cho,Showa-ku,Nagoya,Aichi
TEL
052-744-2245
Homepage URL
fjt@med.nagoya-u.ac.jp
Sponsor or person
Institute
Department of Gastroenterological Surgery (Surgery II), Nagoya University Graduate School of Medicine
Institute
Department
Personal name
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)
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 | 04 | 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
Main results already published
Date of protocol fixation
| 2015 | Year | 04 | Month | 01 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019346
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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