UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008148 |
|---|---|
| Receipt number | R000009374 |
| Scientific Title | Phase I study of weekly low dose Paclitaxel for pancreato-biliary cancers after failure of gemcitabine and 5-FU |
| Date of disclosure of the study information | 2012/06/14 |
| Last modified on | 2020/02/13 22:37:55 |
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Basic information
Public title
Phase I study of weekly low dose Paclitaxel for pancreato-biliary cancers after failure of gemcitabine and 5-FU
Acronym
Palliative chemotherapy with paclitaxel for pancreato-biliary cancers
Scientific Title
Phase I study of weekly low dose Paclitaxel for pancreato-biliary cancers after failure of gemcitabine and 5-FU
Scientific Title:Acronym
Palliative chemotherapy with paclitaxel for pancreato-biliary cancers
Region
| Japan |
Condition
Condition
pancreato-biliary cancers
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Palliative chemotherapy for pancreato-biliary cancers after failure of gemcitabine and oral S-1
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase I
Assessment
Primary outcomes
Determination of recommended dose
Key secondary outcomes
Assessment of safety, Prolonged survival after failur of S-1 and GEM, Response rate, Disease control rate, Adverse event
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
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
patient with pancreatobiliary cancer after failure of gemcitabine and 5FU.
Key exclusion criteria
Patients with a history of anti-cancer agent taxane administration.
Target sample size
9
Research contact person
Name of lead principal investigator
| 1st name | Tetsuo |
| Middle name | |
| Last name | Ohta |
Organization
Kanazawa University Hospital
Division name
Hepato-Biliary-Pancreatic Surgery
Zip code
920-8641
Address
13-1 Takaramachi, Kanazawa
TEL
076-265-2362
hidetaji@staff.kanazawa-u.ac.jp
Public contact
Name of contact person
| 1st name | Hidehiro |
| Middle name | |
| Last name | Tajima |
Organization
Kanazawa University Hospital
Division name
Hepato-Biliary-Pancreatic Surgery
Zip code
920-8641
Address
13-1 Takaramachi, Kanazawa
TEL
076-265-2362
Homepage URL
hidetaji@staff.kanazawa-u.ac.jp
Sponsor or person
Institute
Kanazawa University Hospital
Hepato-Biliary-Pancreatic Surgery
Institute
Department
Personal name
Funding Source
Organization
Kanazawa University Hospital
Hepato-Biliary-Pancreatic Surgery
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
Department of Gastroenterological Surgery, Kanazawa University
Address
13-1 Takaramachi
Tel
076-265-2000
hidetaji@staff.kanazawa-u.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
| 2012 | Year | 06 | Month | 14 | Day |
Related information
URL releasing protocol
DOI: 10.3892/mco.2017.1206 DOI: 10.3892/mco.2018.1579
Publication of results
Published
Result
URL related to results and publications
DOI: 10.3892/mco.2017.1206
Number of participants that the trial has enrolled
16
Results
BTC: PR 3, SD 2, PD 1
PDAC: SD 4, PD 6
Results date posted
| 2020 | Year | 02 | Month | 13 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2016 | Year | 09 | Month | 07 | Day |
Baseline Characteristics
BTC or PDAC patients failure of GEM and 5-FU
Participant flow
See paper
Adverse events
See paper
Outcome measures
See paper
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2012 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2012 | Year | 04 | Month | 02 | Day |
Anticipated trial start date
| 2012 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 12 | Month | 28 | Day |
Date of closure to data entry
| 2016 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2016 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2016 | Year | 08 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 06 | Month | 12 | Day |
Last modified on
| 2020 | Year | 02 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009374
