UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000037 |
|---|---|
| Receipt number | R000000045 |
| Scientific Title | A Multicenter Randomized Controlled Trial to Evaluate the Effect of Adjuvant Chemotherapy using Gemcitabine After Resection of Pancreatic Cancer |
| Date of disclosure of the study information | 2005/08/05 |
| Last modified on | 2012/08/20 11:55:41 |
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Basic information
Public title
A Multicenter Randomized Controlled Trial to Evaluate the Effect of Adjuvant Chemotherapy using Gemcitabine After Resection of Pancreatic Cancer
Acronym
A Randomized Controlled Trial to Evaluate Adjuvant Gemcitabine therapy for Pancreatic Cancer
Scientific Title
A Multicenter Randomized Controlled Trial to Evaluate the Effect of Adjuvant Chemotherapy using Gemcitabine After Resection of Pancreatic Cancer
Scientific Title:Acronym
A Randomized Controlled Trial to Evaluate Adjuvant Gemcitabine therapy for Pancreatic Cancer
Region
| Japan |
Condition
Condition
resectable pancreatic cancer
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of the survival benefit of adjuvant systemic chemotherapy with gemcitabine after resection of pancreatic cancer
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
survival time, recurrence rate
Key secondary outcomes
adverse effect
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
adjuvant systemic chemotherapy with gemcitabine 1000mg/m2 IV on days 1, 8, 15 every 28 days x 3 courses
Interventions/Control_2
observation
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 proven ductal pancreatic cancer
surgical resection
no previous chemo- or radiotherapy
Karnofsky Performance Status >= 50
WBC 4000/mm3 - 12000/mm3
Hb >= 9g/dl
total bilirubin <= 3mg/dl
AST, ALT < upper limit x 5
normal creatinine level
Key exclusion criteria
interstitial pneumonia, pulmonary fibrosis
intractable pleural effusion
distant metastasis
other active cancers
apparent infection
sever postoperative complications
active peptic ulcer
episode of myocardial infarction within three months
mental disorders
pregnacy or patient's hope to be pregnant
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tomoo Kosuge |
Organization
National Cancer Center Hospital
Division name
HBP Surgery Division
Zip code
Address
5-1-1, Tsukiji, Chuo-ku, Tokyo
TEL
03-3542-2511
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomoo Kosuge |
Organization
Office of the Study Group for Adjuvant Chemotherapy of Pancreatic Cancer
Division name
National Cancer Center Hospital, HBP Surgery Division
Zip code
Address
TEL
03-3542-2511
Homepage URL
http://mhlw-grants.niph.go.jp/
Sponsor or person
Institute
Study Group for Adjuvant Chemotherapy of Pancreatic Cancer
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
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
| 2005 | Year | 08 | Month | 05 | 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
| 2002 | Year | 03 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2002 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2006 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
| 2007 | Year | 01 | Month | 01 | Day |
Date trial data considered complete
| 2007 | Year | 03 | Month | 01 | Day |
Date analysis concluded
| 2007 | Year | 04 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2005 | Year | 08 | Month | 04 | Day |
Last modified on
| 2012 | Year | 08 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000045
