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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000009936
Receipt No. R000011638
Scientific Title Feasibility study of adjuvant chemotherapy with alternate-day administrations of S-1 in patients with resected pancreatic cancer
Date of disclosure of the study information 2013/02/02
Last modified on 2018/08/15

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Basic information
Public title Feasibility study of adjuvant chemotherapy with alternate-day administrations of S-1 in patients with resected pancreatic cancer
Acronym Feasibility study of adjuvant alternate-day S-1 therapy for pancreatic cancer
Scientific Title Feasibility study of adjuvant chemotherapy with alternate-day administrations of S-1 in patients with resected pancreatic cancer
Scientific Title:Acronym Feasibility study of adjuvant alternate-day S-1 therapy for pancreatic cancer
Region
Japan

Condition
Condition pancreatic cancer
Classification by specialty
Hepato-biliary-pancreatic surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate treatment completion rate, efficacy and safety of alternate-day administrations of S-1 in patients with pancreatic cancer
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes Treatment completion rate
Key secondary outcomes Overall Survival
Relapse-free Survival
Incidence and Severity of Adverse Events

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
Interventions/Control_1 S-1 is administered orally twice daily after morning and evening meals at a dose of 80-150 mg/day on Mondays, Wednesdays, Fridays and Sundays. The study treatment is repeated for 24 weeks.
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

Not applicable
Gender Male and Female
Key inclusion criteria 1) Resected cases with histologically proven invasive ductal carcinoma of the pancreas
2) According to the UICC classification,
a) Stage I, II, or III
b) R0 or R1
3) No distant metastasis
4) No prior history of chemotherapy nor radiation therapy for pancreatic cancer
5) Age of 20 years or older
6) An Eastern Cooperative Oncology Group performance status of 0 or 1
7) Sufficient organ function:
Neutrophil count >= 1,500 /mm3
Platelet count >= 100,000 /mm3
Hemoglobin >= 9.0 g/dL
Serum total bilirubin <= 2.0 mg/dL,
AST <= 150 IU/L
ALT <= 150 IU/L
Serum creatinine <= 1.2 mg/dL
Creatinine clearance >= 50 mL/min
8) Within 10 weeks after surgery
9) Adequate oral intakes
10) Written informed consent
Key exclusion criteria 1) Contraindication of S-1
2) Active double cancer (synchronous double cancer or asynchronous double cancer with disease-free duration of 3 years or less). Carcinoma in situ and lesions of intramucosal carcinoma will not be included in active double cancer and will be permitted for registration
3)Pulmonary fibrosis or interstitial pneumonia
4)Watery diarrhea
5)Active infections (e.g. patients with pyrexia of 38 degree centigrade or greater), excluding viral hepatitis
6)Serious complications (e.g. heart failure, renal failure, hepatic failure, hemorrhagic peptic ulcer, intestinal paralysis, intestinal obstruction or poorly controlled diabetes).
7)Moderate or severe (requiring drainage) ascites or pleural effusion
8) Current use of flucytosine
9) Pregnant females, possibly pregnant females, females wishing to become pregnant and nursing mothers. Males that are currently attempting to produce a pregnancy.
10) Severe mental disorder.
11) Severe drug allergies.
12) Positive HBs antigen and/or HCV antibody.
13)Physician concludes that the patient's participation in this trial is inappropriate.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Seiichi Takenoshita
Organization Fukushima Medical University Hospital, School of medicine
Division name Department of Organ Regulatory Surgery
Zip code
Address 1 Hikariga-oka, Fukushima City, Fukushima Prefecture 960-1295 JAPAN
TEL 024-547-1111
Email

Public contact
Name of contact person
1st name
Middle name
Last name Tatsuo Shimura
Organization Fukushima Medical University Hospital, School of medicine
Division name Department of Organ Regulatory Surgery
Zip code
Address 1 Hikariga-oka, Fukushima City, Fukushima Prefecture 960-1295 JAPAN
TEL 024-547-1111
Homepage URL
Email

Sponsor
Institute Fukushima Medical University Hospital, School of medicine
Institute
Department

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
Email

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(福島県)
大原綜合病院(福島県)
北福島医療センター(福島県)
社会保険二本松病院(福島県)
星総合病院(福島県)
寿泉堂綜合病院(福島県)

Other administrative information
Date of disclosure of the study information
2013 Year 02 Month 02 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 Terminated
Date of protocol fixation
2012 Year 12 Month 10 Day
Date of IRB
Anticipated trial start date
2013 Year 05 Month 01 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
2013 Year 02 Month 02 Day
Last modified on
2018 Year 08 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011638

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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