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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000003751
Receipt No. R000004546
Scientific Title A phase II feasibility trial of Gemcitabine Hydrochloride and Krestin combination therapy in pancreatic cancer after surgery.
Date of disclosure of the study information 2010/06/30
Last modified on 2010/06/14

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Basic information
Public title A phase II feasibility trial of Gemcitabine Hydrochloride and Krestin combination therapy in pancreatic cancer after surgery.
Acronym A phase II feasibility trial of Gemcitabine Hydrochloride and Krestin combination therapy in pancreatic cancer after surgery.
Scientific Title A phase II feasibility trial of Gemcitabine Hydrochloride and Krestin combination therapy in pancreatic cancer after surgery.
Scientific Title:Acronym A phase II feasibility trial of Gemcitabine Hydrochloride and Krestin combination therapy in pancreatic cancer after surgery.
Region
Japan

Condition
Condition Pancreatic cancer
Classification by specialty
Hepato-biliary-pancreatic surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy and safety of Gemcitabine Hydrochloride and Krestin combination therapy in stage III or IVa pancreatic cancer after surgery as a feasibility trial.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Disease-free survival
Key secondary outcomes 1) Overall survival
2) Incidence of adverse event

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
Medicine
Interventions/Control_1 Gemcitabine Hydrochloride
1000 mg/m2 as Gemcitabine by drip infusion for 30 minutes
Once a week for 3 weeks
One course takes 4 weeks
Maximum 6 courses
Krestin
3 g per day
3 times per day
Daily oral administration
Start at initial administration of Gemcitabine Hydrochloride
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 with invasive ductal pancreatic cancer.
2)Patients with resection of the primary lesion and final findings stage III or IVa.
3)Patients who is between 20 and 80 years old at the time of enrollment.
4)Patients with ECOG Performance Status Scale of 0 or 1.
5)Patients without receiving chemotherapy, radiation therapy and immunotherapy including the treatment for the other carcinoma.
6)Patients who can take medicine orally.
7)Patients who maintain function of main organ in clinical test within 14 days before enrollment.
8)Patients with starting the immunochemotherapy within 2 weeks after enrollment.
9)Patients who have given consent to participate in this clinical study.
Key exclusion criteria 1) Active double cancer.
2) Patients with severe myelosuppression.
3) Patients who receiving radiation therapy to the chest.
4) Patients with severe infection.
5) Patients with pulmonary fibrosis or interstitial lung disease.
6) Pregnant patients.
7) Patients with insanity or psychological symptom.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shinji Uemoto
Organization Kyoto University Hospital
Division name Department of Hepato-Pancreatic Surgery & Transplantation
Zip code
Address 54 Kawara-cho, Shogoin, Sakyo-ku Kyoto 606-8507, JAPAN
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Kyoichi Takaori
Organization Kyoto University Hospital
Division name Department of Hepato-Pancreatic Surgery & Transplantation
Zip code
Address 54 Kawara-cho, Shogoin, Sakyo-ku Kyoto 606-8507, JAPAN
TEL
Homepage URL
Email takaori@kuhp.kyoto-u.ac.jp

Sponsor
Institute Kyoto University Hospital
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Other
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 京都大学医学部附属病院(京都府)
京都警察病院(京都府)

Other administrative information
Date of disclosure of the study information
2010 Year 06 Month 30 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 Preinitiation
Date of protocol fixation
2010 Year 06 Month 10 Day
Date of IRB
Anticipated trial start date
2010 Year 07 Month 01 Day
Last follow-up date
2013 Year 06 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
2010 Year 06 Month 14 Day
Last modified on
2010 Year 06 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004546

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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