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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000018907
Receipt No. 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 2019/08/29

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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
Email 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
Email kokuwaki@kitasato-u.ac.jp

Sponsor
Institute Kitasato University School of Medicine
Institute
Department

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
Email 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 Main results already published
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
2019 Year 08 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021870

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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