UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000624 |
|---|---|
| Receipt number | R000000757 |
| Scientific Title | Randomized controlled phase II trial of gemcitabine/radiation combination therapy and gemcitabine monotherapy in locally advanced pancreatic cancer. |
| Date of disclosure of the study information | 2007/03/03 |
| Last modified on | 2012/04/25 10:34:38 |
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Basic information
Public title
Randomized controlled phase II trial of gemcitabine/radiation combination therapy and gemcitabine monotherapy in locally advanced pancreatic cancer.
Acronym
gemcitabine/radiation combination therapy and gemcitabine monotherapy in pancreatic cancer.
Scientific Title
Randomized controlled phase II trial of gemcitabine/radiation combination therapy and gemcitabine monotherapy in locally advanced pancreatic cancer.
Scientific Title:Acronym
gemcitabine/radiation combination therapy and gemcitabine monotherapy in pancreatic cancer.
Region
| Japan |
Condition
Condition
locally advanced unresectable pancreatic cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of clinical trial is to evaluate gemcitabine/radiation combination therapy compared with gemcitabine monotherapy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
a survival rate for 1 year
Key secondary outcomes
response rate/ safety
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Gemcitabine 1,000mg/m2 is administered with 30-min intravenous infusion on day 1, 8, and 15. The cycle was repeated every 4 weeks until disease progression or unacceptable toxicity is remarked.
Interventions/Control_2
5 weeks concurrent chemo-radiation therapy (CCRT). CCRT is combined radiation (total dose 50 Gy /25 fractions) and weekly Gemcitabine (250mg/m2 administered with 30-min intravenous infusion). 2weeks after CCRT, same protocol with Gemcitabine monotherapy is started.
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 pathologically confirmed locally advanced pancreatic cancer
2.Patients of 20 years old and above
3.Patients without simultaneous other cancers
4.Patients without history of prior therapy for primary disease, excluding billiary drainage
5.ECOG Performance status 0-2
6.Patients with adequate organ function
7.Patients without concomitant diseases required therapy
8.Informed consents are obtained from all patients
Key exclusion criteria
1.Patients with interstitial pneumonia, pulmonary fibrosis.
2.Patients with intractable diabetes mellitus, liver dysfunction, angina pectoris, or myocardinal infarction within 3 months after onset.
3.Patients with suspicious of serious infection, or serious infection
4.Patients with pregnacy, during lactation, or patient with hope of pregnant
5.Patients with severe drug allergy
6.Patients with severe concomitant disease
7.Patients with pleural effusion or ascites
8.Patients with active multiple cancers
9.The patients judged inappropriate in enrolling into this study by the investigators
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ichiro Yasuda |
Organization
Gifu University Hospital
Division name
First Dept. Internal Medicine
Zip code
Address
1-1 Yanagido Gifu
TEL
058-230-6308
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ichiro Yasuda |
Organization
Gifu University Hospital
Division name
First Dept. Internal Medicine
Zip code
Address
1-1 Yanagido Gifu
TEL
058-230-6308
Homepage URL
YASUDAIC@aol.com
Sponsor or person
Institute
First Dept. Internal Medicine
Gifu University Hospital
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
Gifu Municipal Hospital,
Gifu Prefecural General Medical Center,
Takayama Red Cross Hospital
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
| 2007 | Year | 03 | Month | 03 | 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
Completed
Date of protocol fixation
| 2007 | Year | 02 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 03 | 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
| 2007 | Year | 03 | Month | 01 | Day |
Last modified on
| 2012 | Year | 04 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000757
