UMIN-CTR Clinical Trial

Basic information
Public title	Phase II study of alternate-day administrations of S-1 as 2nd-line treatment in patients with metastatic and locally advanced pancreatic cancer
Acronym	Phase II study of alternate-day administrations of S-1 as 2nd-line treatment in patients with metastatic and locally advanced pancreatic cancer
Scientific Title	Phase II study of alternate-day administrations of S-1 as 2nd-line treatment in patients with metastatic and locally advanced pancreatic cancer
Scientific Title:Acronym	Phase II study of alternate-day administrations of S-1 as 2nd-line treatment in patients with metastatic and locally advanced pancreatic cancer
Region	Japan

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

Objectives
Narrative objectives1	To evaluate the efficacy and safety of alternate-day S-1 administration for 2nd-line metastatic and locally advanced pancreatic cancer
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	Overall Survival
Key secondary outcomes	Time to Treatment Failure, Disease Control Rate, Adverse Events, Administration Rate of S-1

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	Alternate-day administrations of S-1
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	80 years-old >
Gender	Male and Female
Key inclusion criteria	1)Histologically confirmed pancreatic cancer as adenocarcinoma or adenosquamous carcinoma 2)Non-resectable and confirmed target region 3)History of prior treatment without S-1 4)Age 20-79 5)PS 0/1 6)Adequate organ functions neutrophils >=2,000/mm3 leukocytes >=3,500/mm3 platelets >=100,000/mm3 hemoglobin >=9.0g/dL AST(GOT)/ALT(GPT) <=150IU/L total bilirubin <=2.0mg/dL serum creatinine <=1.2mg/dL creatinine clearance >=60mL/min 7)Sufficient oral intake 8)Normal ECG 9)Written informed concent
Key exclusion criteria	1)Symptomatic pulmonary fibrosis or interstitial pneumonia 2)Severe diarrhea 3)Active infection 4)Severe complications, such as ileus, heart failure and renal failure 5)Marked pleural or peritoneal effusion 6)Metastasis in central nervous system 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)History of severe anaphylaxies 12)Inadequate physical condition, as diagnosed by primary physician
Target sample size	45

Research contact person
Name of lead principal investigator	1st name Hiroki Middle name Last name Yamaue
Organization	Wakayama Medical University, School of Medicine
Division name	Second Department of Surgery
Zip code	6418510
Address	811-1 Kimiidera, Wakayama 641-8510, Japan
TEL	073-441-0613
Email	yamaue-h@wakayama-med.ac.jp

Public contact
Name of contact person	1st name Atsushi Middle name Last name Shimizu
Organization	Wakayama Medical University, School of Medicine
Division name	Second Department of Surgery
Zip code	6418510
Address	811-1 Kimiidera, Wakayama 641-8510, Japan
TEL	073-441-0613
Homepage URL
Email	atsus28@wakayama-med.ac.jp

Sponsor
Institute	Pancreatic Cancer Treatment Research Group
Institute
Department

Funding Source
Organization	Pancreatic Cancer Treatment Research Group
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	Wakayama Medical University, School of Medicine
Address	811-1 Kimiidera, Wakayama 641-8510, Japan
Tel	073-441-0613
Email	atsus28@wakayama-med.ac.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

Other administrative information
Date of disclosure of the study information	2010 Year 04 Month 06 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	2009 Year 07 Month 12 Day
Date of IRB	2009 Year 08 Month 01 Day
Anticipated trial start date	2009 Year 08 Month 01 Day
Last follow-up date	2013 Year 07 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2010 Year 04 Month 06 Day
Last modified on	2019 Year 10 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000004175