UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020475 |
|---|---|
| Receipt number | R000023458 |
| Scientific Title | Phase I study of chemoradiotherapy using gemcitabine plus nab-paclitaxel for unresectable locally advanced pancreatic cancer |
| Date of disclosure of the study information | 2016/01/07 |
| Last modified on | 2018/07/25 14:53:15 |
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Basic information
Public title
Phase I study of chemoradiotherapy using gemcitabine plus nab-paclitaxel for unresectable locally advanced pancreatic cancer
Acronym
Phase I study of chemoradiotherapy using gemcitabine plus nab-paclitaxel for unresectable locally advanced pancreatic cancer
Scientific Title
Phase I study of chemoradiotherapy using gemcitabine plus nab-paclitaxel for unresectable locally advanced pancreatic cancer
Scientific Title:Acronym
Phase I study of chemoradiotherapy using gemcitabine plus nab-paclitaxel for unresectable locally advanced pancreatic cancer
Region
| Japan |
Condition
Condition
unresectable locally advanced pancreatic cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To confirm the safety of chemoradiotherapy using gemcitabine plus nab-paclitaxel and to determine the Recommended Dose for unresectable locally advanced pancreatic cancer
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
incidence of dose limiting toxicity (within 2 courses)
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
(1)Concurrent radiotherapy is delivered in 28 fractions (a total dose of 50.4Gy).
(2)Gemcitabine+Nab-Paclitaxel is intravenously administered on day 1,8 and 15 every 4 weeks.
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
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1)pancreatic cancer
(2)no distant metastasis
(3)unresectable defined by NCCN guideline
(4)age 20-75
(5)Performance Status:0-1(ECOG)
(6)initial treatment
(7)Radiotherapist determines that all of the primary tumor and lymph node metastasis is possible to be included in the radiation field of 10cm X 10cm
(8)biliary drainage for obstructive jaundice
(9)no invasion of digestive tract
(10)no other organ cancer
(11)adequate oral intake
(12)Life expectancy more than 3 months
(13)adequate organ function (bone marrow, liver, kidney etc)
(14)written informed consent
Key exclusion criteria
(1)other distant metastasis
(2)allergy of gemcitabine or nab-paclitaxel
(3)invasion of digestive tract
(4)severe drug allergy
(5)active infection
(6)severe heart disease
(7)severe complications(bowel obstruction, lung fibrosis, interstitial pneumonia, diabetes, renal failure, liver cirrhosis)
(8)active synchronous cancer
(9)peripheral neuropathy
(10)uncontrollable ascites or pleural effusion
(11)active gastrointestinal bleeding
(12)severe diarrhea
(13)mental disorder
(14)pregnancy
(15)no informed consent
(16)inappropriate case
(17)pulmonary fibrosis, interstitial pneumonia
(18)history of abdominal irradiation
(19)uncontrollable carcinomatous pain
(20)Lung in the pulmonary field
Target sample size
24
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,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
名古屋大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 01 | Month | 07 | 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
| 2016 | Year | 01 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 03 | 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
| 2016 | Year | 01 | Month | 07 | 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=R000023458
