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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000008148
Receipt No. 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

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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
Email 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
Email hidetaji@staff.kanazawa-u.ac.jp

Sponsor
Institute Kanazawa University Hospital
Hepato-Biliary-Pancreatic Surgery
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009374

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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