UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026525 |
|---|---|
| Receipt number | R000030448 |
| Scientific Title | A phase II study of gemcitabine and nab-paclitaxel followed by chemoradiotherapy with S-1 in patients with locally advanced pancreatic cancer |
| Date of disclosure of the study information | 2017/03/13 |
| Last modified on | 2022/03/23 12:45:07 |
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Basic information
Public title
A phase II study of gemcitabine and nab-paclitaxel followed by chemoradiotherapy with S-1 in patients with locally advanced pancreatic cancer
Acronym
A phase II study of gemcitabine and nab-paclitaxel followed by chemoradiotherapy with S-1 in patients with locally advanced pancreatic cancer
Scientific Title
A phase II study of gemcitabine and nab-paclitaxel followed by chemoradiotherapy with S-1 in patients with locally advanced pancreatic cancer
Scientific Title:Acronym
A phase II study of gemcitabine and nab-paclitaxel followed by chemoradiotherapy with S-1 in patients with locally advanced pancreatic cancer
Region
| Japan |
Condition
Condition
Locally advanced pancreatic cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine | Hematology and clinical oncology | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To assess the efficacy and safety of
gemcitabine and nab-paclitaxel followed by
chemoradiotherapy with S-1 in patients
with locally advanced pancreatic cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Overall 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
GEM+nab-PTX for 12 weeks or 3cycles:
nab-PTX 125mg/m2 day1, 8, 15 every 4 weeks
GEM 1000 mg/m2 day1, 8, 15 every 4 weeks
S-1+RT:
S-1 80/100/120 mg/day based on BSA, day1-14 and 22-35
RT 1.8Gy/day, 28fractions, total 50.4Gy
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)Radiographic diagnosis of pancreatic ductal adenocarcinoma and histologic or
cytologic confirmation of adenocarcinoma
(2)Unresectable locally advanced pancreatic cancer without distant metastases
(3)No evidence of gastroduodenal invasion or obstruction
(4)Age: 20-75
(5)ECOG PS: 0 or 1
(6)No prior chemotherapy or radiotherapy
(7)Written informed consent
(8)Adequate organ function
Key exclusion criteria
(1)Severe concurrent disease
(2)Interstitial pneumonia or severe pulmonary emphysema
(3)Clinically significant mental disorder
(4)Active concomitant malignancy
(5)Moderate or severe diarrhea, hemorrhagic colitis or peptic ulcer
(6)Infection requiring systemic treatment
(7)Fever of 38 degrees centigrade or higher
(8)Pregnant or lactating females
(9)Under treatment with systemic steroid or immunosuppressive agent
(10)Severe drug hypersensitivity
(11)Regular use of phenytoin, warfarin or frucitocin
(12)Gr2 or more peripheral sensory neuropathy
(13)Inappropriate for entry onto the study, as diagnosed by primary physician
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kentaro Sudo |
Organization
Chiba Cancer Center
Division name
Gastroenterology
Zip code
Address
Nitona-cho 666-2, Chuo-ku, Chiba, Japan 260-8717
TEL
043-264-5431
ksudo@chiba-cc.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kentaro Sudo |
Organization
Chiba Cancer Center
Division name
Gastroenterology
Zip code
Address
Nitona-cho 666-2, Chuo-ku, Chiba, Japan 260-8717
TEL
043-264-5431
Homepage URL
ksudo@chiba-cc.jp
Sponsor or person
Institute
Chiba Cancer Center
Institute
Department
Personal name
Funding Source
Organization
None
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
| 2017 | Year | 03 | Month | 13 | 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
| 2017 | Year | 03 | Month | 08 | Day |
Date of IRB
| 2017 | Year | 03 | Month | 08 | Day |
Anticipated trial start date
| 2017 | Year | 03 | Month | 14 | Day |
Last follow-up date
| 2021 | Year | 12 | 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
| 2017 | Year | 03 | Month | 13 | Day |
Last modified on
| 2022 | Year | 03 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030448
