UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018907 |
|---|---|
| Receipt number | R000021870 |
| Scientific Title | Clinical trial on the Feasibility and Efficacy of nab-PTX+GEM combination chemotherapy for elderly patients with advanced pancreatic cancer |
| Date of disclosure of the study information | 2015/09/04 |
| Last modified on | 2024/01/28 10:50:02 |
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Basic information
Public title
Clinical trial on the Feasibility and Efficacy of nab-PTX+GEM combination chemotherapy for elderly patients with advanced pancreatic cancer
Acronym
Feasibility and Efficacy of nab-PTX+GEM combination chemotherapy for elderly patients
Scientific Title
Clinical trial on the Feasibility and Efficacy of nab-PTX+GEM combination chemotherapy for elderly patients with advanced pancreatic cancer
Scientific Title:Acronym
Feasibility and Efficacy of nab-PTX+GEM combination chemotherapy for elderly patients
Region
| Japan |
Condition
Condition
pancreatic cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This clinical trial to evaluate Feasibility and Efficacy of nab-PTX+GEM combination chemotherapy on elderly patients with advanced pancreatic cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
adverse events, completion rates of two cycles chemotherapy, relative dose intensity, postponed rates of chemotherapy, reduced rates of dose, disease control rate and progression free survival
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 75 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
patients who had been already obtained informed consent for nab-PTX+GEM combination chemotherapy before registration time; histologically proven unresectable pancreatic adenocarcinoma or adenosquamous carcinoma; age more than 75 years; an expected survival period of more than 3 months; Eastern Cooperative Oncology Group performance status 0-1; measurable lesion by RECIST.(Ver.1.1); no prior chemotherapy and radiotherapy; adequate organ function as evidenced by the following laboratory studies within 7 days prior to enrollment (leukocyte count </=12,000/mm3, neutrophil count >= 1.500/mm3, hemoglobin >= 9.0 g/dl, platelets >= 100,000/mm3, AST/ALT </= ULN x 2.5 U/L, total bilirubin </= ULN x 1.25 mg/dL, creatinine clearance>= 60 ml/min, CRP </=1.5 mg/dL, HbA1c <8.4%,); no abnormal electrocardiogram; patients with agreement of this cohort study.
Key exclusion criteria
age less than 75 years; impossible to use both iodine and gadolinium due to being allergic to contrast agent; severe mental disorders; any other cases who are regarded as inadequate for study enrollment by investigators.
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | Mitsuhiro |
| Middle name | |
| Last name | Kida |
Organization
Kitasato University School of Medicine
Division name
Department of Gstroenterology
Zip code
252-0375
Address
1-1-15 Kitasato Minami Sagamihara Kanagawa 252-0375 Japan
TEL
81-42-778-8111
m-kida@kitasato-u.ac.jp
Public contact
Name of contact person
| 1st name | Kosuke |
| Middle name | |
| Last name | Okuwaki |
Organization
Kitasato University School of Medicine
Division name
Department of Gstroenterology
Zip code
252-0375
Address
1-1-15 Kitasato Minami Sagamihara Kanagawa 252-0375 Japan
TEL
81-42-778-8111
Homepage URL
kokuwaki@kitasato-u.ac.jp
Sponsor or person
Institute
Kitasato University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
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
Kitasato University Institutional Review Board
Address
1-1-15 Kitasato Minami Sagamihara Kanagawa 252-0375 Japan
Tel
81-42-778-7756
rinri@med.kitasato-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
北里大学病院
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 09 | Month | 04 | 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 | 09 | Month | 01 | Day |
Date of IRB
| 2015 | Year | 09 | Month | 01 | Day |
Anticipated trial start date
| 2015 | Year | 09 | Month | 07 | Day |
Last follow-up date
| 2018 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This clinical trial to evaluate Feasibility and Efficacy of nab-PTX+GEM combination chemotherapy on elderly patients with advanced pancreatic cancer.
Management information
Registered date
| 2015 | Year | 09 | Month | 04 | Day |
Last modified on
| 2024 | Year | 01 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021870
