UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028116 |
|---|---|
| Receipt number | R000032118 |
| Scientific Title | Phase II study of chemoradiotherapy combined with gemcitabine and nab-paclitaxel for unresectable locally advanced pancreatic cancer |
| Date of disclosure of the study information | 2017/08/01 |
| Last modified on | 2019/08/14 14:39:47 |
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Basic information
Public title
Phase II study of chemoradiotherapy combined with gemcitabine and nab-paclitaxel for unresectable locally advanced pancreatic cancer
Acronym
NUPAT 05
Scientific Title
Phase II study of chemoradiotherapy combined with gemcitabine and nab-paclitaxel for unresectable locally advanced pancreatic cancer
Scientific Title:Acronym
NUPAT 05
Region
| Japan |
Condition
Condition
Unresectable locally advanced pancreatic cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine | Hematology and clinical oncology | Hepato-biliary-pancreatic surgery |
| Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate efficacy and safety of chemoradiotherapy with gemcitabine and nab-paclitaxel for unresectable locally advanced pancreatic cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
2-year survival rates
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
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Gemcitabine (800mg/m2) and nab-paclitaxel (100mg/ m2) are planed to be administered on Day 1, 8, 15, respectively concurrent with radiotherapy to 50.4 Gy in 28 fractions fore the treatment of unresectable locally advanced pancreatic cancer.
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) Patients who were diagnosed to be pancreatic cancer
2) No distant metastasis
3) Diagnosed unresectable locally advanced pancreatic by rresectability defined by NCCN guideline
4) 20 years of age to 75 years of age
5) ECOG performance status score of 0, 1
6) No prior chemotherapy
7) Primary tumor and adjacent lymph nodes can be treated within 10*10 cm radiation field
8) Enough biliary drainage
9) No invasion to digestive tract
10) No synchronic cancer of other organs
11) Enough oral intake
12) Life expectancy at least 3 months
13) Adequate major organs' function
Key exclusion criteria
1) Distant metastasis
2) Allergy to gemcitabine or nab-paclitaxel
3) Invasion to digestive tract
4) Severe allergy to drags
5) Infection
6) Severe cardiovascular disease
7) Severe basal disease
8) Double cancer
9) Peripheral sensory neuropathy or myelopathy
10) ascites or pleural effusion
11) Active digestive tract bleeding
12) Severe diarrhea
13) Fibroid lung
14) History of radiotherapy for abdomen
15) Uncontrolled cancer pain
16) Lung would be included within radiation field
17) Uncontrolled severe mental disease
18) Pregnant
19) Not obtained consent to this trail
20) Not appropriate for the study at the physician's assessment.
Target sample size
25
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
Gastroenterological Surgery
Zip code
Address
56, Tsurumai-cho, Showa-ku, Nagoya city, Japan
TEL
052-744-2249
ykodera@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Suguru Yamada |
Organization
Nagoya University Graduate School of Medicine
Division name
Gastroenterological Surgery
Zip code
Address
56, Tsurumai-cho, Showa-ku, Nagoya city, Japan
TEL
(81)52-744-2249
Homepage URL
suguru@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University Pancreatic Tumor Bord
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 | 08 | 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
Enrolling by invitation
Date of protocol fixation
| 2017 | Year | 07 | Month | 02 | Day |
Date of IRB
| 2017 | Year | 12 | Month | 04 | Day |
Anticipated trial start date
| 2017 | Year | 12 | Month | 04 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 04 | 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 | 07 | Month | 06 | Day |
Last modified on
| 2019 | Year | 08 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032118
