UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020977 |
|---|---|
| Receipt number | R000024207 |
| Scientific Title | preoperative gemcitabine based chemoradiation therapy for resectable and borderline resectable pancreatic cancer phase1 study |
| Date of disclosure of the study information | 2016/04/01 |
| Last modified on | 2021/08/15 22:17:46 |
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Basic information
Public title
preoperative gemcitabine based chemoradiation therapy for resectable and borderline resectable pancreatic cancer phase1 study
Acronym
Preoperative chemoradiation therapy for pancreatic cancer
Scientific Title
preoperative gemcitabine based chemoradiation therapy for resectable and borderline resectable pancreatic cancer phase1 study
Scientific Title:Acronym
Preoperative chemoradiation therapy for pancreatic cancer
Region
| Japan |
Condition
Condition
resectable and borderline resectable pancreatic cancer
Classification by specialty
| Hepato-biliary-pancreatic surgery | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate safety of preoperative gemcitabine based chemoradiation therapy for pancreatic cancer.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase I
Assessment
Primary outcomes
occurrence of side effect of preoperative gemcitabine based chemoradiation therapy
Key secondary outcomes
postoperative complication, 2-year recurrence-free survival, 2-year overall survival, recurrence site
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine | Other |
Interventions/Control_1
gemcitabine (1000mg/m2) treated on day1,8,15,29,36,43,57,64,71
radiation thrapy;54gly(1.8Gly * 30days)
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) histopathologically diagnosed pancreatic cancer
2) performance status: 0-1 (eco grade)
3) pancreatic cancer, diagnosed as resectable by enhanced computed tomography
4) patient who expected to have more than 6 month survival at start of the treatment
5) patient with normal organ function
white blood cell:>3500/mm3,<10,000/mm3
neutrophil: >2,000/mm3
lymphocyte: >1,500/mm3
platelet: >100,000/mm3
hemoglobin: >9.0g/dl
total bilirubin: <2.0mg/dl
ast, alt:>150 u/l
serum creatinine:<1.2mg/dl
Key exclusion criteria
1) unresectable pancreatic cancer
1 distant organ metastasis
2 peritoneal dissamination
3 para aortic lymph node metastasis
4 pancreatic cancer with artery invasion, such as abdominal aorta, superior mesenteric artery, ceriac artery, common hepatic artery, or proper hepatic artery.
5 portal vein invasion beyond reconstruction
patient with interstitial lung disease or fibroid lung
patient with severe diarrhea
active viral infection excluding viral hepatitis
patient with double cancer
a woman of childbearing potential
patient with severe psychological disorder
patient with severe allergy to any drug
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Shigeru |
| Middle name | |
| Last name | Marubashi |
Organization
Fukushima medical university
Division name
Division of Hepato-Biliary-Pancreatic and Transplant surgery
Zip code
9601295
Address
fukushima hikarigaoka 1
TEL
024-547-1111
mgotoh@fmu.ac.jp
Public contact
Name of contact person
| 1st name | Naoya |
| Middle name | |
| Last name | sato |
Organization
Fukushima medical university
Division name
Division of Hepato-Biliary-Pancreatic and Transplant surgery
Zip code
9601295
Address
fukushima hikarigaoka 1
TEL
024-547-1111
Homepage URL
nawoya2U@gmail.com
Sponsor or person
Institute
fukushima medical university
Institute
Department
Personal name
Funding Source
Organization
fukusima medical university
department of regenerative surgery
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
Fukushima medical university
Address
Fukushima Hikarigaoka-1
Tel
0245471254
nawoya@fmu.ac.jp
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
福島県立医科大学附属病院
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 04 | Month | 01 | 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
30
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
No longer recruiting
Date of protocol fixation
| 2016 | Year | 02 | Month | 10 | Day |
Date of IRB
| 2016 | Year | 04 | Month | 01 | Day |
Anticipated trial start date
| 2016 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 02 | Month | 01 | Day |
Date of closure to data entry
| 2021 | Year | 02 | Month | 28 | Day |
Date trial data considered complete
| 2021 | Year | 10 | Month | 01 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 02 | Month | 10 | Day |
Last modified on
| 2021 | Year | 08 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024207
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| Registered date | File name |
| Research case data | |
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