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Recruitment status Terminated
Unique ID issued by UMIN UMIN000010326
Receipt No. R000011541
Scientific Title A randomized phase II trial using highly bioavailable curcumin in patients with unresectable advanced pancreatic cancer
Date of disclosure of the study information 2013/04/01
Last modified on 2016/11/16

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Basic information
Public title A randomized phase II trial using highly bioavailable curcumin in patients with unresectable advanced pancreatic cancer
Acronym A randomized phase II trial using highly bioavailable curcumin in patients with unresectable advanced pancreatic cancer
Scientific Title A randomized phase II trial using highly bioavailable curcumin in patients with unresectable advanced pancreatic cancer
Scientific Title:Acronym A randomized phase II trial using highly bioavailable curcumin in patients with unresectable advanced pancreatic cancer
Region
Japan

Condition
Condition advanced pancreatic cancer
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy of highly bioavailable curcumin on patients with advanced pancreatic cancer
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Phase II

Assessment
Primary outcomes overall survival
Key secondary outcomes Quality of life (QOL) score, Time to Treatment Failure, response rate, safety

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Double blind -all involved are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Theracurmin
Interventions/Control_2 placebo
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. Patients with histologically or cytologically comfirmed pancreatic cancer who have not received palliative chemotherapy
2. Age >/=20
3. ECOG performance status </=2
4. Adequate oral intake
5. Adequate organ and bone marrow function
6. Provided written informed consent
Key exclusion criteria 1.Patients with active interstitial pneumonia or pulmonary fibrosis
2.Patients with digestive tract obstruction confirmed by imaging test
3.Patients with moderate or severe ascites /pleural effusion
4.Patients with uncontrollable diabetes mellitus, liver dysfunction, severe heart disease
5.Patients with serious infection
6.Patients with a history of severe drug allergy
7.Patients with other serious comorbid diseases
8.Patients with other advanced cancer
9.Pregnant women or patients who wish pregnant
10.Patients with mental diseases
11.Patients who are judged inappropriate for the entry into the study by the investigator
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masashi Kanai
Organization Kyoto University Hospital
Division name Department of Clinical Oncology and Pharmacogenomics
Zip code
Address 54 Shogoin-Kawahara-cho, Sakyo-ku, Kyoto
TEL 075-751-4770
Email kanai@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kanai Masashi
Organization Kyoto University Hospital
Division name Department of Clinical Oncology and Pharmacogenomics
Zip code
Address 54 Shogoin Kawahara-cho, Sakyo-ku, Kyoto 606-8507
TEL 075-751-4770
Homepage URL
Email kanai@kuhp.kyoto-u.ac.jp

Sponsor
Institute Kyoto University Hospital
Institute
Department

Funding Source
Organization Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2013 Year 04 Month 01 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 Terminated
Date of protocol fixation
2013 Year 03 Month 12 Day
Date of IRB
Anticipated trial start date
2013 Year 05 Month 10 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
2013 Year 03 Month 27 Day
Last modified on
2016 Year 11 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011541

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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