UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028101 |
|---|---|
| Receipt number | R000032172 |
| Scientific Title | Multicenter phase II study of neoadjuvant chemotherapy of gemcitabine+nab-paclitaxel therapy for patients with resectable pancreatic cancer. |
| Date of disclosure of the study information | 2017/08/15 |
| Last modified on | 2017/07/06 15:14:21 |
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Basic information
Public title
Multicenter phase II study of neoadjuvant chemotherapy of gemcitabine+nab-paclitaxel therapy for patients with resectable pancreatic cancer.
Acronym
Multicenter phase II study of neoadjuvant GEM+nab-PTX for resectable pancreatic cancer.
Scientific Title
Multicenter phase II study of neoadjuvant chemotherapy of gemcitabine+nab-paclitaxel therapy for patients with resectable pancreatic cancer.
Scientific Title:Acronym
Multicenter phase II study of neoadjuvant GEM+nab-PTX for resectable pancreatic cancer.
Region
| Japan |
Condition
Condition
Invasive ductal adenocarcinoma
Classification by specialty
| Hepato-biliary-pancreatic medicine | Hematology and clinical oncology | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety and efficacy of gemcitabine+nab-paclitaxel therapy as neoadjuvant chemotharpy for resectable pancreatic cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
2 year progression-free survival rate (the initial date in reckoning is set at the date of registration)
Key secondary outcomes
Overall survival from registration
Radiological response rate
R0 resection rate
Histological response rate
Protocol compliance
Relative dose intensity
Incidence of adverse events
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 and nab-paclitaxel therapy as neoadjuvant therapy
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
1. Resectable pancreatic cancer
2. Adenocarcinoma or adenosquamous carcinoma
3. Age 20-79
4. ECOG PS 0-1
5. Able to eat orally
6. Appropriate biliary drainage if bile duct obstructed
7. No apparent sensory or motor neuropathy
8. No history of chemotherapy within last 3 years
9. No prior therapy for pancreatic cancer 10. Meet all the criteria of laboratory examination
11. Informed consent by patient
Key exclusion criteria
1. History of gemcitabine, nab-paclitaxel
2. Ongoing active other malignancy
3. Allergic to gemcitabine and nab-
4. Computed tomography contrast media allergy
5. poor control of diarrhea
6. Intestinal pneumonia
7. Moderate amount of ascites or pleural effusion
8. Active infection
9. Poor control of diabetes mellitus
10. Serious comorbid conditions
11.Myocardial infarction within last 6 months
12. Systemic steroid therapy
13. Serious psychiatric diseases
14. Planning a baby or pregnancy
15. Planning a baby
16. Judged unable to guarantee safety
Target sample size
45
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hirochika Toyama |
Organization
Kobe University Graduate School of Medicine
Division name
Division of Hepato-biliary-pancreatic Surgery Department of Surgery
Zip code
Address
7-5-2, Kusunoki-cho, Chuo-ku, Kobe, Hyogo, Japan
TEL
078-382-6302
tymhr@me.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hirochika Toyama |
Organization
Kobe University Graduate School of Medicine
Division name
Division of Hepato-biliary-pancreatic Surgery Department of Surgery
Zip code
Address
7-5-2, Kusunoki-cho, Chuo-ku, Kobe, Hyogo, Japan
TEL
078-382-6302
Homepage URL
tymhr@me.com
Sponsor or person
Institute
Division of Hepato-biliary-pancreatic Surgery Department of Surgery, Kobe University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Self-funding
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
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
神戸大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 08 | Month | 15 | 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
Preinitiation
Date of protocol fixation
| 2017 | Year | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 09 | 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
| 2017 | Year | 07 | Month | 06 | Day |
Last modified on
| 2017 | Year | 07 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032172
