UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase II study of 3-weeks cycle of S-1 as first-line for advanced pancreatic cancer (PACS-3)
Title of the study (Brief title)	3-weeks cycle of S-1 for pancreatic cancer (PACS-3)
Region	Japan

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

Objectives
Narrative objectives1	To evaluate efficacy and safety of 3-weeks cycle of S-1 as first-line chemotherapy for advanced pancreatic cancer
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	Overall survival
Key secondary outcomes	Progression free survival Response rate Safety

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	TS-1 will be orally administered twice daily (after breakfast and supper) for 14 consecutive days at one of the doses (50mg, 80 mg, 100 mg, 120 mg/day) adjusted for body surface area, then withdrawn for 7 days. One cycle consists of 21 days and administration will be continued until patients satisfy any of the conditions for discontinuation of the study treatment.
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) Pancreatic carcinoma histologically determined to be adenocarcinoma or adenosquamous carcinoma. 2) Advanced unresectable pancreatic cancer. 3) Patients with no previous treatment (radiotherapy, chemotherapy etc) for pancreatic cancer, except resection. 4) Age: between 20 and 79 years at registration. 5) ECOG Performance Status (PS) of 0 or 1. 6) Sufficient function of major organs as defined below. White blood cell count: 3500/mm3 Neutrophil count: 2000/mm3 Hemoglobin: 9.0 g/dL Platelet count: 100000/mm3 Total bilirubin: 2.0 mg/dL AST and ALT: 150 U/L Serum creatinine: 1.2 mg/dL Creatinine clearance: 50mL/min 7) Able to take capsules orally. 8) No clinically abnormal ECG findings within 28 days before registration. 9) Voluntarily signed the written consent form.
Key exclusion criteria	1) Pulmonary fibrosis or interstitial pneumonia. 2) Watery diarrhoea. 3) Active infections, excluding viral hepatitis. 4) Serious complications (e.g. heart failure, renal failure, hepatic failure, haemorrhagic peptic ulcer, intestinal paralysis, intestinal obstruction or poorly controlled diabetes). 5) Moderate or severe ascites or pleural effusion requiring treatment. 6) Metastasis in the CNS. 7) Active double cancer. 8) Patients under treatment with flucytosine, phenytoin or warfarin potassium. 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) Judged ineligible by physicians for participation in the study from a safety viewpoint.
Target sample size	70

Research contact person
Name of lead principal investigator	Ichiro Yasuda
Organization	Gifu University graduate school of medicine
Division name	Department of Gastroenterology
Address	1-1 Yanagido, Gifu city
TEL	058-230-6308
Email

Public contact
Name of contact person	Shinpei Doi
Organization	Gifu University graduate school of medicine
Division name	Department of Gastroenterology
Address	1-1 Yanagido, Gifu city
TEL	058-230-6308
Homepage URL
Email	doisin@nifty.com

Sponsor
Institute	Gifu University Hospital
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	Gifu Prefectural Medical Center Gifu Municipal Hospital Kurume University Hospital Japanese Red Cross Nagoya Daini Hospital Nagoya City University Hospital Mie University Hospital
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	岐阜大学医学部附属病院（岐阜県） 岐阜県総合医療センター（岐阜県） 岐阜市民病院（岐阜県） 久留米大学医学部附属病院（福岡県） 名古屋第二赤十字病院（愛知県） 名古屋市立大学医学部附属病院（愛知県） 三重大学医学部附属病院（三重県）

Other administrative information
Date of disclosure of the study information	2013 Year 07 Month 12 Day

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2013 Year 07 Month 02 Day
Anticipated trial start date	2013 Year 07 Month 10 Day
Last follow-up date	2017 Year 05 Month 30 Day
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 07 Month 12 Day
Last modified on	2018 Year 01 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000012997