UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000028933
Receipt number R000033114
Scientific Title Regorafinib escalation for colorectal cancer
Date of disclosure of the study information 2017/10/01
Last modified on 2018/03/02 10:58:35

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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 or person

Institute

Department of Coloproctological Surgery, Juntendo University Hospital

Institute

Department

Personal name



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

Value
https://center6.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