UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000000624
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email

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
Email YASUDAIC@aol.com

Sponsor
Institute First Dept. Internal Medicine
Gifu University Hospital
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000757

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.