UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Feasibility study of adjuvant chemotherapy with alternate-day administrations of S-1 in patients with resected pancreatic cancer
Title of the study (Brief title)	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	Seiichi Takenoshita
Organization	Fukushima Medical University Hospital, School of medicine
Division name	Department of Organ Regulatory Surgery
Address	1 Hikariga-oka, Fukushima City, Fukushima Prefecture 960-1295 JAPAN
TEL	024-547-1111
Email

Public contact
Name of contact person	Tatsuo Shimura
Organization	Fukushima Medical University Hospital, School of medicine
Division name	Department of Organ Regulatory Surgery
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)

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

Progress
Recruitment status	Terminated
Date of protocol fixation	2012 Year 12 Month 10 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000011638