UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009172 |
|---|---|
| Receipt number | R000010762 |
| Scientific Title | Phase II study of neoadjuvant S-1 concurrent radiotherapy for borderline resectable pancreatic cancer |
| Date of disclosure of the study information | 2012/10/23 |
| Last modified on | 2013/11/26 04:43:02 |
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Basic information
Public title
Phase II study of neoadjuvant S-1 concurrent radiotherapy for borderline resectable pancreatic cancer
Acronym
JASPAC05
Scientific Title
Phase II study of neoadjuvant S-1 concurrent radiotherapy for borderline resectable pancreatic cancer
Scientific Title:Acronym
JASPAC05
Region
| Japan |
Condition
Condition
borderline resectable pancreatic cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of neoadjuvant S-1 and concurrent radiotherapy for borderline resectable pancreatic cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
curative R0 resection rate
Key secondary outcomes
overall survival, recurrence free survival, response rate, pathological response rate, 2 year survival rate, adverse event, surgical complication, response rate based on the central radiological diagnosis
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
neoadjuvant S-1 and concurrent radiotherapy
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
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) adenocarcinoma or adenosquamous carcinoma
2) no distant metastasis
3) borderline resectable pancreatic cancer
4) age 20-75
5) ECOG PS 0-1
6) No prior therapy
7) can be included in the irradiation field of 10cm x10cm
8) good oral intake
9) adequate biliary drainage for obstructive jaundice
10) no invasion to digestive tract
11) good main organ function
12) written informed consent
Key exclusion criteria
1) no prior fluoropyrimidine anticancer therapy
2) prior abdominal radiotherapy
3) diarrhea
4) iodine contrast allergy
5) pulmonary fibrosis or interstitial pneumonitis
6) ascites or pleural effusion
7) active infection
8) poor controlled diabetes
9) active other malignancy
10) active digestive ulcer
11) serious complications
12) continuous steroid administration
13) severe mental disorder
14) pregnancy
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masafumi Ikeda |
Organization
National Cancer Center Hospital East
Division name
Division of Hepatobiliary and Pancreatic Oncology
Zip code
Address
6-5-1 Kashiwanoha, Kashiwa city, Chiba 277-8577, JAPAN
TEL
+81-471-33-1111
masikeda@east.ncc.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Izumi Ohno |
Organization
National Cancer Center Hospital East
Division name
Division of Hepatobiliary and Pancreatic Oncology
Zip code
Address
6-5-1 Kashiwanoha, Kashiwa city, Chiba 277-8577, JAPAN
TEL
+81-471-33-1111
Homepage URL
ioono@east.ncc.go.jp
Sponsor or person
Institute
JASPAC
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
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
国立がん研究センター東病院 （千葉県）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 10 | Month | 23 | 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
Open public recruiting
Date of protocol fixation
| 2012 | Year | 06 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 10 | Month | 23 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 10 | Month | 23 | Day |
Last modified on
| 2013 | Year | 11 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010762
