UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017694 |
|---|---|
| Receipt number | R000020429 |
| Scientific Title | Efficacy of neoadjuvant chemoradiotherapy with Metformin for locally advanced pancreatic cancer |
| Date of disclosure of the study information | 2015/05/28 |
| Last modified on | 2022/12/12 17:47:39 |
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Basic information
Public title
Efficacy of neoadjuvant chemoradiotherapy with Metformin for locally advanced pancreatic cancer
Acronym
PK-NACRT-Gmet
Scientific Title
Efficacy of neoadjuvant chemoradiotherapy with Metformin for locally advanced pancreatic cancer
Scientific Title:Acronym
PK-NACRT-Gmet
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
To evaluate the anticancer effect of neoadjuvant chemoradiotherapy using gemcitabine with metformin for locally advanced pancreatic cancer.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the ratio of histological remnant cancer cells
Key secondary outcomes
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 | Other |
Interventions/Control_1
Duration: 3 months
Dose
Neoadjuvant chemoradiation: Gemcitabine(150mg/m2/w)+RT(50.4G/28f)
Metformin: from 5days before starting neoadjuvant chemoradiation until surgery.(1500mg/3x)
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) Certification of pancreatic cancer (histological confirmation is desired).
2) Beyond borderline resectable pancreatic cancer (NCCN guideline 2013 ver.1).
3) No prior anti-tumor therapy for pancreatic cancer.
4) Patient age: over 20 years old, 80 years old or less.
5) Performance status (ECOG) is 0 or 1.
6) Essential organ function is preserved.
WBC counts: over 3000/mm3
Neutrophil counts: over 2000/mm3
Platelets counts: over10^4/mm3
Hb: over 9 g/dl
TBil: below 3.0 mg/dl
AST/ALT: 5 times less than the upper limit of normal
Serum creatinine: below 1.3mg/dl (male) 1.2mg/dl (female)
7) Patients with type 2 diabetes
8) Written consent has been obtained from the patient himself.
Key exclusion criteria
1) Pulmonary fibrosis or interstitial pneumonia
2) severe infectious disease
3) Patients with uncontrolled heart failure , angina, arrhythmias, and myocardial infarction within 6 months after the onset.
4) uncontrolled diabetes
5) Patients with active infection
6) Patients with pregnant women, the possibility or intention of lactating and pregnant.
7)severe drug allergy
8)peptic ulcer and bleeding
9)obvious neurological disorder or mental disorder
10)active double cancer
11)Patients who are already administered metformin
12)other severe complications
13)The patients who are judged inadequate to the present study by Principal investigator or researcher.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Akinobu |
| Middle name | |
| Last name | Taketomi |
Organization
Hokkaido University Graduate School of Medicine
Division name
Gastroenterological Surgery 1
Zip code
060-8638
Address
N15, W-7, Kita-ku Sapporo Japan
TEL
011-706-5927
taketomi@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | Tatsuhiko |
| Middle name | |
| Last name | Kakisaka |
Organization
Hokkaido University Hospital
Division name
Gastroenterological Surgery 1
Zip code
060-8638
Address
N15, W-7, Kita-ku Sapporo Japan
TEL
011-706-5927
Homepage URL
kakisaka@pop.med.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University Graduate School of Medicine Gastroenterological Surgery 1
Institute
Department
Personal name
Funding Source
Organization
Hokkaido University Graduate School of Medicine Gastroenterological Surgery 1
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
Hokkaido University Hospital Division of Clinical Research Administration
Address
Kita 14, Nishi 5, Kita-ku, Sapporo, Hokkaido, 060-8648 Japan
Tel
011-701-7636
crjimu@huhp.hokudai.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
北海道大学病院（北海道）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 05 | Month | 28 | 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
Enrolling by invitation
Date of protocol fixation
| 2015 | Year | 05 | Month | 25 | Day |
Date of IRB
| 2015 | Year | 05 | Month | 14 | Day |
Anticipated trial start date
| 2015 | Year | 06 | Month | 18 | Day |
Last follow-up date
| 2025 | Year | 12 | 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
| 2015 | Year | 05 | Month | 27 | Day |
Last modified on
| 2022 | Year | 12 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020429
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| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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