UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023591 |
|---|---|
| Receipt number | R000027167 |
| Scientific Title | Feasibility study of neoadjuvant gemcitabine plus nab-paclitaxel for borderline resectable pancreatic cancer |
| Date of disclosure of the study information | 2016/08/10 |
| Last modified on | 2024/09/19 06:07:16 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Feasibility study of neoadjuvant gemcitabine plus nab-paclitaxel for borderline resectable pancreatic cancer
Acronym
Feasibility study of NAC GEM+nab-PTX for BRPC
Scientific Title
Feasibility study of neoadjuvant gemcitabine plus nab-paclitaxel for borderline resectable pancreatic cancer
Scientific Title:Acronym
Feasibility study of NAC GEM+nab-PTX for BRPC
Region
| Japan |
Condition
Condition
Borderline resectable pancreatic cancer
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 feasibility of neoadjuvant gemcitabine plus nab-paclitaxel in patients with borderline resectable pancreatic cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Feasibility for 2 cycles of GEM+nab-PTX therapy
Key secondary outcomes
R0 resection rate, Response rate, Histological effect, Adverse events, Severe adverse events, Treatment-related death
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
Administration of neoadjuvant GEM+nab-PTX
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Diagnosed as pancreatic cancer by imaging and histologically proven adenocarcinoma
2) No distant metastasis
3) Borderline resectable pancreatic cancer by NCCN Guidelines Version 2.2015
4) Without ascites/pleural effusion
5) Measurable disease not mandatory
6) Eastern Cooperative Oncology Group performance status 0-1
7) Peripheral neuropathy (Grade0 or 1)
8) No prior therapy for malignancy
9) Adequate organ function
10) Written informed consent
Key exclusion criteria
1) With pulmonary fibrosis or interstitial pneumonia
2) With active double cancers
3) With severe complications such as heart failure, bowel obstruction and uncontrollable diabetes millitus
4) With active infection
5) Pregnant or lactating women or women of childbearing potential and men who want to get partner pregnant
6) Psychosis or severe mental disorder
7) Recieving systemic steroid therapy
8) With severe drug allergy
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Junji Furuse |
Organization
Kyorin University, School of Medicine
Division name
Department of Medical Oncology
Zip code
Address
6-20-2, Shinkawa, Mitaka-shi, Tokyo, 181-8611, Japan
TEL
0422-47-5511
jfuruse@ks.kyorin-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Naohiro Okano |
Organization
Kyorin University, School of Medicine
Division name
Department of Medical Oncology
Zip code
Address
6-20-2, Shinkawa, Mitaka-shi, Tokyo, 181-8611, Japan
TEL
0422-47-5511
Homepage URL
naohiro-okano@ks.kyorin-u.ac.jp
Sponsor or person
Institute
Kyorin University, School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Kyorin University, School of Medicine
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
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 08 | Month | 10 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://doi.org/10.2169/internalmedicine.9504-22
Number of participants that the trial has enrolled
10
Results
Two-cycle NAC (neoadjuvant)-GnP (gemcitabine plus nab-paclitaxel) is a feasible treatment for patients with borderline-resectable pancreatic cancer (BRPC).
Further studies on NAC-GnP in patients with BRPC are warranted.
Results date posted
| 2024 | Year | 09 | Month | 19 | Day |
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
| 2016 | Year | 06 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 06 | Month | 24 | 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 | 08 | Month | 10 | Day |
Last modified on
| 2024 | Year | 09 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027167
