UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020681 |
|---|---|
| Receipt number | R000023796 |
| Scientific Title | Randomized open-label phase II study of adjuvant chemotherapy of S-1 plus metformin vs. S-1 alone in patients with resected pancreatic cancer |
| Date of disclosure of the study information | 2016/01/22 |
| Last modified on | 2023/07/27 14:10:16 |
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Basic information
Public title
Randomized open-label phase II study of adjuvant chemotherapy of S-1 plus metformin vs. S-1 alone in patients with resected pancreatic cancer
Acronym
Randomized open-label phase II study of adjuvant chemotherapy of S-1 plus metformin vs. S-1 alone in patients with resected pancreatic cancer(ASMET)
Scientific Title
Randomized open-label phase II study of adjuvant chemotherapy of S-1 plus metformin vs. S-1 alone in patients with resected pancreatic cancer
Scientific Title:Acronym
Randomized open-label phase II study of adjuvant chemotherapy of S-1 plus metformin vs. S-1 alone in patients with resected pancreatic cancer(ASMET)
Region
| Japan |
Condition
Condition
Pancreatic cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To compare the efficacy of adjuvant chemotherapy of metformin in combination with S-1 versus S-1 for as assessed by Overall Survival in resected pancreatic patients.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
2-year survival rate (overall survaival)
Key secondary outcomes
Recurrence free survival time
Adverse event rate
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
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
A:S-1+Metformin
S-1 day1-14 of each 21-day cycle, until progression disease or completion of the planned 6 months
Treatment for diabetes: Metformin 500mg/day day1-21, subsequently 750mg/day for 2 years
Interventions/Control_2
B:S-1
S-1 day1-14 of each 21-day cycle, until progression disease or completion of the planned 6 months
Treatment for diabetes: Any diabetic treatment without Metformin for 2 years
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Histologically confirmed invasive ductal carcinoma of pancreas and after radical pancreatic resection
2)The primary tumor has been macrospically complete resected and meet all of the following the histopathological staging in UICC seventh edition
･StageIIor less
･StageIII underwent celiac artery resection for complete tumor removal
･Local residual tumor status is
R0 or R1
･Intraoperative peritoneal lavage cytology is negative
3)Neither distant metastasis nor malignant ascites
4)Oral nutrition is sufficiently maintained
5)No previous cancer treatment history other than pancreatic resection for pancreatic cancer
6)The patient is >= 20 years old at the time of obtaining informed consent
7)The patient has an Eastern Cooperative Oncology Group(ECOG)Performance Status (PS) of 0 or 1
8)The patient discontinued any chemotherapy and any radiotherapy>= 3years prior to randomization
9)The patient received radical pancreatic resection within 12 weeks prior to randomization
10)Impaired glucose tolerance was observed to meet one of the following diagnostic criteria for diabetes even once throughout the entire period prior to randomization
･Fasting plasma glucose level>= 126mg/dl
･Plasma glucose level at any time>=200mg/dl
･Diabetes type in 75gOGTT
･HbA1c(NGSP) >= 6.5%
･HbA1c(JDS) >= 6.1%
11)The patient has adequate major organ function and meet all of the following requirements within 7 days prior to randomization:(HBs antigen test is only allowed within 28 days prior to randomization.)
･White blood cell count(WBC) >=3,000/mm3 and<= 12,000/mm3
･Absolute neutrophil count(ANC) >=1,500/mm3
･Platelets>=100,000/mm3
･Hemoglobin>=8.0g/dL
･Total bilirubin<=2.0mg/dL
･Aspartate transaminase(AST) and alanine transaminase(ALT) <=150IU/L
･Serum creatinine<=1.5mg/dL
･Ccr>=50mL/min
･HBs antigen is negative
12)The patient has provided signed informed consent prior to randomization
Key exclusion criteria
1)Any previous therapy with S-1 or any DPP-4 inhibitor or any GLP-1
2)Any anticancer therapy,(including hormone therapy, immunotherapy, and natural-origin and plant supplement etc.)within 1-year prior to randomization and any neoajduvant therapy
3)A history of serious complications associated with resection
4)Reccurence in the examination prior to randomization
*But it is not concluded that only incomplete decrease of tumor marker or only tiny ascites with CT means recurrence
5)Moderate or more pleural effusion or ascites with chest X-ray or abdominal CT
6)Apparent pulmonary fibrosis or interstitial pneumonia with chest X-ray or with clinical symptom
7)A history of gastrointestinal disorder concerning for dehydration status
8)Symptomatic congestive heart failure: New York Heart Association III-IV
9)Severe ketosis, diabetic coma or pre-coma, or type 1 diabetes
10)Malnutrition, starvation, general prostration condition, pituitary dysfunction or adrenal insufficiency.
11)A history of onset of myocardial infarction within 6 months
12)Active infection
13)Positive for HBs antigen
14)A history blood transfusion within 2 weeks prior to randomization
15)A history of lactic acidosis
16)Moderate or severe renal dysfunction or has received dialysis
17)Severe liver dysfunction
18)The patienttends to run into hypoxia status
19)The patient intakes excessive alcohol
20)Other severe complication
21)Any psychosis or psychiatric symptoms
22)Active multiple primary cancer(simultaneous one or heterochronous one accompanied by disease-free time within 3 years)
23)A female with pregnancy , breast-feeding,possibility of pregnancy,intention of pregnancy, or desire od delivery
24)A male with intention of having children.
25)The patient receives flucytosine, phenytoin, or warfarin potassium
26)The patient is determined to be unsuitable to safely carry out the study
Target sample size
160
Research contact person
Name of lead principal investigator
| 1st name | Terumasa |
| Middle name | |
| Last name | Hisano |
Organization
National Kyushu Cancer Center
Division name
Department of Hepato-Biliary-Pancreatology
Zip code
811-1395
Address
Notame 3-1-1,Minami-Ku, Fukuoka
TEL
092-541-3231
idling3000@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Masayuki |
| Middle name | |
| Last name | Furukawa |
Organization
National Kyushu Cancer Center
Division name
Department of Hepato-Biliary-Pancreatology
Zip code
811-1395
Address
Notame 3-1-1,Minami-Ku, Fukuoka
TEL
092-541-3231
Homepage URL
nhoebm@gmail.com
Sponsor or person
Institute
National Hospital Organization
Institute
Department
Personal name
Funding Source
Organization
National Hospital Organization
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Hospital Organization Review Board for Cli nical Trials (Nagoya)
Address
4-1-1 Sannomaru Naka-ku Nagoya ,Aichi, Japan
Tel
052-951-1111
311-nmc-rec@mail.hosp.go.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
函館病院（北海道）、高崎総合医療センター（群馬県）、災害医療センター（東京）、まつもと医療センター（長野県）、金沢医療センター（石川県）、静岡医療センター（静岡県）、京都医療センター（京都府）、大阪医療センター（大阪府）、米子医療センター（鳥取県）、呉医療センター（広島県）、福山医療センター（広島県）、関門医療センター（山口県）、岩国医療センター（山口県）、四国がんセンター（愛媛県）、九州がんセンター（福岡県）、福岡東医療センター（福岡県）、長崎医療センター（長崎県）、別府医療センター（大分県）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 01 | Month | 22 | 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
76
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
| 2015 | Year | 11 | Month | 10 | Day |
Date of IRB
| 2015 | Year | 11 | Month | 10 | Day |
Anticipated trial start date
| 2018 | Year | 01 | Month | 26 | Day |
Last follow-up date
| 2024 | Year | 01 | Month | 26 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 01 | Month | 21 | Day |
Last modified on
| 2023 | Year | 07 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023796
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