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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000028933
Receipt No. R000033114
Scientific Title Regorafinib escalation for colorectal cancer
Date of disclosure of the study information 2017/10/01
Last modified on 2018/03/02

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Basic information
Public title Regorafinib escalation for colorectal cancer
Acronym RECC Study
Scientific Title Regorafinib escalation for colorectal cancer
Scientific Title:Acronym 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
1st name
Middle name
Last name Kazuhiro Sakamoto
Organization Juntendo University Hospital
Division name Juntendo University Hospital
Zip code
Address 3-1-3, Hongo, Bunkyo-ku, Tokyo, Japan
TEL 03-3813-3111
Email kazusaka@juntendo.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takeshi Yamada
Organization Nippon medical school hospital
Division name Digestive Surgery
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

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 Open public recruiting
Date of protocol fixation
2016 Year 12 Month 28 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000033114

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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