UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024505 |
|---|---|
| Receipt number | R000028203 |
| Scientific Title | Low-dose gemcitabine plus nab-paclitaxel versus standard-dose gemcitabine plus nab-paclitaxel in elderly patients with metastastic pancreatic cancer: A randomized phase II trial |
| Date of disclosure of the study information | 2016/10/20 |
| Last modified on | 2023/10/26 10:54:51 |
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Basic information
Public title
Low-dose gemcitabine plus nab-paclitaxel versus standard-dose gemcitabine plus nab-paclitaxel in elderly patients with metastastic pancreatic cancer: A randomized phase II trial
Acronym
Low-dose gemcitabine plus nab-paclitaxel versus standard-dose gemcitabine plus nab-paclitaxel in elderly patients with metastastic pancreatic cancer
Scientific Title
Low-dose gemcitabine plus nab-paclitaxel versus standard-dose gemcitabine plus nab-paclitaxel in elderly patients with metastastic pancreatic cancer: A randomized phase II trial
Scientific Title:Acronym
Low-dose gemcitabine plus nab-paclitaxel versus standard-dose gemcitabine plus nab-paclitaxel in elderly patients with metastastic pancreatic cancer
Region
| Japan |
Condition
Condition
Metastatic pancreatic cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To assess the efficacy of low-dose gemcitabine plus nab-paclitaxel compared with standard-dose gemicitabine plus nab-paclitaxel for elderly patients with metastatic pancreatic cancer
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Response rate
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
To receive a 30-minite intravenous infusion of nab-paclitaxel at a dose of 125 mg per square meter, followed by an infusion of gemcitabine at a dose of 1000 mg per square meter for standard group, on days 1, 8, 15 every 4 weeks until discontinuation.
Interventions/Control_2
To receive a 30-minite intravenous infusion of nab-paclitaxel at a dose of 125 mg per square meter, followed by an infusion of gemcitabine at a dose of 250 mg per square meter for low-dose group, on days 1, 8, 15 every 4 weeks until discontinuation.
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Histologically or cytologically confirmed adenocarcinoma of the pancreas
2)Metastatic pancreatic cancer
3)Case that is measurable. Imaging examination is finished within 4 weeks.
4)Case that chemotherapy or radiation had not been performed.
5)More than 65-years-old
6)Performance Status 0 or 1
7)Case without major organ disorders
8)Case without abnormality on ECG within 4 weeks
9)Obtain informed concent
Key exclusion criteria
1)Pulmonary fibrosis/pneumonia interstitialis
2)Serous diarrhea
3)Active infection
4)Serious complication
5)modelate or severe pleural effusion/ascites
6)Brain metastasis with sympsons
7)Active multiple primary cancer
8)Use of warfarin potassium
9)During pregnancy
10)Serious mental disorders
11)The other inappropriate case
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Mamoru |
| Middle name | |
| Last name | Takenaka |
Organization
Kindai University
Division name
Gastroenterology and Hepatology
Zip code
589-8511
Address
377-2 Ohno-higashi, Osaka-sayama 589-8511, Japan
TEL
072-366-0221
mamoxyo45@gmail.com
Public contact
Name of contact person
| 1st name | Ken |
| Middle name | |
| Last name | Kamata |
Organization
Kindai University
Division name
Gastroenterology and Hepatology
Zip code
589-8511
Address
377-2 Ohno-higashi, Osaka-sayama 589-8511, Japan
TEL
072-366-0221
Homepage URL
ky11@leto.eonet.ne.jp
Sponsor or person
Institute
Kindai University
Institute
Department
Personal name
Funding Source
Organization
Kindai University
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
Kindai Univercity faculty of medicine
Address
377-2, Ohno-higashi, Osaka-sayamashi
Tel
072-366-0221
zizen@med.kindai.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
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 10 | Month | 20 | 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
| 2016 | Year | 07 | Month | 07 | Day |
Date of IRB
| 2016 | Year | 11 | Month | 15 | Day |
Anticipated trial start date
| 2016 | Year | 11 | Month | 15 | Day |
Last follow-up date
| 2024 | Year | 08 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 10 | Month | 20 | Day |
Last modified on
| 2023 | Year | 10 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028203
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| Registered date | File name |
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