UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016852 |
|---|---|
| Receipt number | R000019542 |
| Scientific Title | Phase II study of Gemcitabine + nab-paclitaxel as first-line therapy for locally advanced pancreatic cancer |
| Date of disclosure of the study information | 2015/03/23 |
| Last modified on | 2020/07/01 18:16:39 |
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Basic information
Public title
Phase II study of Gemcitabine + nab-paclitaxel as first-line therapy for locally advanced pancreatic cancer
Acronym
Phase II study of Gemcitabine + nab-paclitaxel as first-line therapy for locally advanced pancreatic cancer
Scientific Title
Phase II study of Gemcitabine + nab-paclitaxel as first-line therapy for locally advanced pancreatic cancer
Scientific Title:Acronym
Phase II study of Gemcitabine + nab-paclitaxel as first-line therapy for locally advanced pancreatic cancer
Region
| Japan |
Condition
Condition
locally advanced unresectable pancreatic cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of first line GEM+ nab-PTX combination therapy for 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
Response rate
Key secondary outcomes
Overall survival, progression free survival, 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
Patients receiving nab-PTX plus gemcitabine will receive 125 mg/m2, nab-PTX as a 30- to
40-minute infusion (maximum infusion time not to exceed 40 minutes) followed by 1000 mg/m2 gemcitabine as a 30- to 40-minute infusion (maximum 40 minutes) for 3 weeks followed by a week of rest.
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) Histlogically proven adenocarcinoma or adeno-squamous carcinoma
2) Unresectable locally advanced pancreatic cancer
3) No prior chemotherapy and radiotherapy for other malignancies
4) Age upper 20 and less than 80
5) ECOG performance status of 0, 1
6) Adequate hematologic, hepatic and renal function
7) Written informed consent
Key exclusion criteria
1) Patients with Distant metastasis
2) Patients with symptomatic pulmonary fibrosis or interstitial pneumonia
3) Patient has active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy.
4) Patients has severe complications, such as heart failure, renal failure ileus and severe mental disorder
5) History of malignancy in the last 3 years
6) History of Peripheral Artery Disease (eg, claudication, Leo Buerger's disease).
7) History of connective tissue disorders (eg, lupus, scleroderma, arteritis nodosa).
8) Women who are pregnant or expect to be pregnant, or nursing female
9) Others
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | Takuji |
| Middle name | |
| Last name | Torimura |
Organization
Kurume university school of medicine
Division name
Division of gastroenterology
Zip code
8300011
Address
Kurume-shi
TEL
0942-31-7561
takahashi_kenjirou@med.kurume-u.ac.jp
Public contact
Name of contact person
| 1st name | Masaru |
| Middle name | |
| Last name | Fukahori |
Organization
Kurume university school of medicine
Division name
Division of gastroenterology, multidisciplinary cancer treatment center
Zip code
830-0011
Address
67 Asahi-machi, Kurume city, Fukuoka
TEL
0942-31-7561
Homepage URL
digdug0526@gmail.com
Sponsor or person
Institute
Kurume university school of medicine
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
The Ethical Committee of Kurume University
Address
67 Asahi-machi, Kurume city, Fukuoka
Tel
0942-31-7917
aro_crc@kurume-u.ac.jp
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
久留米大学病院(福岡県)
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 03 | Month | 23 | 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
| 2015 | Year | 03 | Month | 20 | Day |
Date of IRB
| 2015 | Year | 03 | Month | 16 | Day |
Anticipated trial start date
| 2015 | Year | 03 | Month | 23 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2020 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2020 | Year | 04 | Month | 03 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 03 | Month | 20 | Day |
Last modified on
| 2020 | Year | 07 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019542
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