UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010326 |
|---|---|
| Receipt number | 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 12:13:05 |
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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
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
kanai@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011541
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
