UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001386 |
|---|---|
| Receipt number | R000001344 |
| Scientific Title | Phase I/II study of complementary therapy using curcumin for gemcitabine-refractory pancreatic cancer patients |
| Date of disclosure of the study information | 2008/09/24 |
| Last modified on | 2010/10/25 09:28:40 |
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Basic information
Public title
Phase I/II study of complementary therapy using curcumin for gemcitabine-refractory pancreatic cancer patients
Acronym
Phase I/II study of curcumin for pancreatic cancer patients
Scientific Title
Phase I/II study of complementary therapy using curcumin for gemcitabine-refractory pancreatic cancer patients
Scientific Title:Acronym
Phase I/II study of curcumin for pancreatic cancer patients
Region
| Japan |
Condition
Condition
Advanced pancreatic cancer patients who get refractory to gemcitabine-based chemotherapy
Classification by specialty
| Hepato-biliary-pancreatic medicine | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Our purpose is to evaluate the safety and feasibility of complementary therapy using curcumin for gemcitabine-refractory pancreatic cancer patients
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase I,II
Assessment
Primary outcomes
Phase I; Safety
Phase II; Feasibility of complementary therapy using curcumin
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Curcumin (8g/day) is orally added to gemcitabine-based chemotherapy until disease progression, unacceptable adverse events, patient withdrawal or death.
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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Patients must have histologically or cytologically confirmed carcinoma of the pancreas that is not amenable to resection with curative intent.
2. Patients who have failed gemcitabine-based therapy and no other therapy is available.
3. Age >/= 18 years and </= 80 years.
4. ECOG performance status </=1
5. Adequate oral intake is maintained.
6. Patients must have adequate organ and marrow function.
7. Patients present written informed consent.
Key exclusion criteria
1. Patients with interstitial pneumonia or pulmonary fibrosis.
2. Patients with uncontrollable diabetes mellitus, liver disease, angina pectoris or a new onset of myocardial infarction within 3 months 3. Patients with severe infection.
4. Patients with history of severe drug allegy
5. Patients with other serious comorbid diseases
6. Patients with advanced cancer other than pancreatic cancer
7. Pregnant women or patients who wish pregnant
8. Patients with mental diseases
9. Patients who are judged inappropriate for the entry into the study by the investigater
Target sample size
21
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kanai Masashi |
Organization
Kyoto University Hospital
Division name
Outpatient Oncology Unit
Zip code
Address
54 Shogoin-Kawahara-cho 54, Sakyo-ku, Kyoto
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Kyoto University Hospital
Division name
Translational Research Center
Zip code
Address
TEL
075-751-3397
Homepage URL
Sponsor or person
Institute
Kyoto University Hospital, Outpatient Oncology Unit
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
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
| 2008 | Year | 09 | Month | 24 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
| 2008 | Year | 03 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2010 | 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
| 2008 | Year | 09 | Month | 22 | Day |
Last modified on
| 2010 | Year | 10 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001344
| 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 |
