UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Regorafinib escalation for colorectal cancer
Title of the study (Brief title)	RECC Study
Region	Japan

Condition
Condition	metastatic colorectal cancer
Classification by specialty	Gastroenterology Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	The efficacy and safety of Regorafinib does escalation therapy as third or fourth line therapy for colorectal cancer
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	progression free survival
Key secondary outcomes

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	Regorafinib: 80mg/body/day, given orally for 7 days. After confirmation of acceptability, daily dosage is escalated to 120mg/body/day and given for 7 days. After confirmation of acceptability again, daily dosage is escalated to 160mg/body/day.
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 proven colorectal cancer 2)patient who has unresectable primary tumor or with one or more unresectable metastatic tumor(s) 3)treatment history of two or more regimens for metastatic colorectal cancer, and who has confirmed PD in imaging study 4)20<= and 80>= years old 5)ECOG performance status of 0 or 1 6)With measurable lesions according 7)ability to tolerate oral drug administration 8)a life expectancy of at least 3 months 9)Patient who has adequate main organ functions in tests within 14 days before enrollment leukocyte >=3,500/mm3 neutrophil >=1,500/mm3 platelet >=75,000/mm3 hemoglobin concentration >=8.0 g/dL serum total bilirubin level <=1.5 mg/dL serum creatinine <=1.5 mg/dL serum AST and ALT levels <2.5x Upper limit of normal (ULN). serum creatinine <=1.5 mg/dL Peripheral neuropathy<=grade2 Diarrhea and Non-hematotoxicity =<grade1 10)gave written informed consent
Key exclusion criteria	1)contraindications for Regorafinib 2)previously received chemotherapy with Regorafinib 3)severe drug allergy 4)pregnant woman or Possibility of the pregnant woman. male patient who hoping partner's pregnancy. 5)patient who has severe clinical complications (symptomatic unstable ischemic heart disease, arrhythmia, acute myocardial infarction within 6 months, liver cirrhosis, renal failure, active gastrointestinal ulcer, ileus, uncontrolled diabetes, uncontrolled hypertension, etc.) 6)other active malignancies 7)severe disorder of liver function 8)Uncontrollable hypertension 9)Severe complication 10)Synchronous or metachronous multiple malignancy within the last 5 year disease free interval 11)Under continuous steroid administration 12)decision of unsuitable for this study by the investigator
Target sample size	55

Research contact person
Name of lead principal investigator	Kazuhiro Sakamoto
Organization	Juntendo University Hospital
Division name	Juntendo University Hospital
Address	3-1-3, Hongo, Bunkyo-ku, Tokyo, Japan
TEL	03-3813-3111
Email	kazusaka@juntendo.ac.jp

Public contact
Name of contact person	Takeshi Yamada
Organization	Nippon medical school hospital
Division name	Digestive Surgery
Address	1-1-5, Sendagi, Bunkyo-ku, Tokyo, Japan
TEL	03-3822-2131
Homepage URL
Email	y-tak@nms.ac.jp

Sponsor
Institute	Department of Coloproctological Surgery, Juntendo University Hospital
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Other
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	2017 Year 10 Month 01 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2016 Year 12 Month 28 Day
Anticipated trial start date	2017 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	2017 Year 08 Month 31 Day
Last modified on	2018 Year 03 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000033114