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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000020681
Receipt No. 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 2019/07/25

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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 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
Email nhoebm@gmail.com

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
Email nhoebm@gmail.com

Sponsor
Institute National Hospital Organization
Institute
Department

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 Org anization Review Board for Clinical Trials (Headquarters)
Address 2-5-21 Hig ashig aoka Meg uro-ku Tokyo , Japan Tokyo
Tel 03-5712-5050
Email 700-kenkyu@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 北海道医療センター(北海道)、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)、横浜医療センター(神奈川県)、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)、敦賀医療センター(福井県)、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)、東広島医療センター(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)、熊本医療センター(熊本県)、熊本南病院(熊本県)、別府医療センター(大分県)、鹿児島医療センター(鹿児島県)

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
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 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
2023 Year 01 Month 25 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
2019 Year 07 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023796

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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