UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Multicenter phase II study of oral S-1 monotherapy in advanced colorectal cancer who have failed prior oxaliplatin and irinotecan-based therapies
Title of the study (Brief title)	Multicenter phase II study of oral S-1 monotherapy in advanced colorectal cancer who have failed prior oxaliplatin and irinotecan-based therapies <CCOG-1103 (C3-01)>
Region	Japan

Condition
Condition	Colorectal cancer
Classification by specialty	Gastroenterology Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy and safety of oral S-1 monotherapy in advanced colorectal cancer who have failed prior oxaliplatin and irinotecan-based therapies
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	Progression free survival
Key secondary outcomes	One year survival rate, Overall survival, Response rate, Disease control rate, Time to treatment failure, Toxicity

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 monotherapy
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) Histopathologically confirmed colorectal cancer (2) Unresectable advanced colorectal cancer patients who have failed prior oxaliplatin and irinotecan-based therapies (3) Measurable or evaluable disease (RECIST ver.1.1.) (4) Colorectac cancer with Kras mutant type gene (5) Age of 20 years or older (6) ECOG performance status 0-1 (7) Alife expectancy greater than 3 months (8) Written informed concent (9) Adequate organ function
Key exclusion criteria	(1) Uncontrolled infection. (2) Patient with symptomatic cardiovascular disease or asymptomatic disease but have been treated (>=Grade 2 according to NCI-CTCAE ver.4). History of myocardial infarction within a year. (3) Severe lung disease. (4) Interstitial lung disease or pulmonary fibrosis. (5) Severe liver disease. (6) Severe renal failure, or urinary protein (more than 2+). (7) Previous history of severe drug-induced allergy (8) ileus, bowel obstruction (9) Uncontrolled severe complications (DM, hypertension, diarrhea, et al.). (10) History of active double cancer. (11) Massive pleural effusion or ascites that required drainage. (12) Brain metastasis (13) Pregnant women, possibly pregnant women, wishing to become pregnant, and nursing mothers. (14) Not appropriate for the study at the physician's assessment.
Target sample size	34

Research contact person
Name of lead principal investigator	Goro Nakayama
Organization	Nagoya University Gradeate School of Medicine
Division name	Department of Gastroenterology
Address	65,turumaityou,syouwaku,nagoya city
TEL	052-744-2250
Email	goro@med.nagoya-u.ac.jp

Public contact
Name of contact person	Takahiro Asada, Koji Torii
Organization	Nagoya University Gradeate School of Medicine
Division name	Department of Gastroenterology
Address	65,turumaityou,syouwaku,nagoya city
TEL	052-744-2250
Homepage URL	http://www.med.nagoya-u.ac.jp/surgery2/scientific/ccog/
Email	goro@med.nagoya-u.ac.jp

Sponsor
Institute	Chube Clinical Oncology Group (CCOG)
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

Other administrative information
Date of disclosure of the study information	2011 Year 10 Month 06 Day

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2011 Year 09 Month 26 Day
Anticipated trial start date	2011 Year 10 Month 01 Day
Last follow-up date	2016 Year 09 Month 01 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	2011 Year 10 Month 05 Day
Last modified on	2016 Year 11 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000007697