UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001923 |
|---|---|
| Receipt number | R000002344 |
| Scientific Title | A randomized trial of chemoradiotherapy and chemotherapy for locally advanced pancreatic cancer |
| Date of disclosure of the study information | 2009/04/30 |
| Last modified on | 2014/05/02 10:10:54 |
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Basic information
Public title
A randomized trial of chemoradiotherapy and chemotherapy for locally advanced pancreatic cancer
Acronym
A randomized trial for locally advanced pancreatic cancer
Scientific Title
A randomized trial of chemoradiotherapy and chemotherapy for locally advanced pancreatic cancer
Scientific Title:Acronym
A randomized trial for locally advanced pancreatic cancer
Region
| Japan |
Condition
Condition
pancreatic cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine | Hepato-biliary-pancreatic surgery | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This phase III study was conducted to evaluate the efficacy and toxicity of EBRT combined with S-1 for locally advanced pancreatic cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
overall survival
Key secondary outcomes
progression-free survival
tumor response
toxicity
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
EBRT & S-1
Interventions/Control_2
S-1 alone
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
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
histologically or cytologically confirmed adenocarcinoma of the pancreas;clinically or surgically staged and considered unresectable for cure;life expectancy greater than 6 months;measurable or assessable disease; life expectancy of > 3 months; adequate organ
Key exclusion criteria
active infection; severe heart disease; interstitial pneumonitis or pulmonary fibrosis; pleural effusion or ascites; active gastroduodenal ulcer; pregnant or lactating females; severe mental disorder; active concomitant malignancy; other serious medical conditions.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroyuki Shinchi |
Organization
Kagoshima University Graduate School
Division name
Department of Surgical Oncology and HBP Surgery
Zip code
Address
8-35-1 Sakuragaoka, Kagoshima 890-8520, Japan
TEL
099-275-5361
shinchi@m.kufm.kagoshima-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroyuki Shinchi |
Organization
Kagoshima University Graduate School
Division name
Department of Surgical Oncology and HBP Surgery
Zip code
Address
8-35-1, Sakuragaoka, Kagoshima 890-8520, JAPAN
TEL
099-275-6756
Homepage URL
shinchi@m.kufm.kagoshima-u.ac.jp
Sponsor or person
Institute
Department of Surgical Oncology and HBP Surgery, Kagoshima University Graduate School
Institute
Department
Personal name
Funding Source
Organization
Kagoshima University Graduate School
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
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
| 2009 | Year | 04 | Month | 30 | Day |
Related information
URL releasing protocol
Publication of results
Partially 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
| 2009 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
| 2014 | Year | 04 | Month | 01 | Day |
Date trial data considered complete
| 2014 | Year | 04 | Month | 01 | Day |
Date analysis concluded
| 2014 | Year | 04 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2009 | Year | 04 | Month | 30 | Day |
Last modified on
| 2014 | Year | 05 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002344
