UMIN-CTR Clinical Trial

Basic information
Public title	The prospective study of the clinical efficacy/adverse event of regorafenib in unresectable metastatic and advanced colorectal cancer
Acronym	Prediction of the Efficacy/Adverse event of Regorafenib in advanced Colorectal cancer (PEARC study)
Scientific Title	The prospective study of the clinical efficacy/adverse event of regorafenib in unresectable metastatic and advanced colorectal cancer
Scientific Title:Acronym	Prediction of the Efficacy/Adverse event of Regorafenib in advanced Colorectal cancer (PEARC study)
Region	Japan

Condition
Condition	Colorectal cancer
Classification by specialty	Gastroenterology
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	To evaluate the relationship between the blood concentration of regorafenib and the dosage amount, and to evaluate the association with clinical efficacy/adverse event and identify the potent polymorphisms and biomarkers.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	To evaluate the association with clinical efficacy/adverse event of regorafenib
Key secondary outcomes	To explore the potent polymorphisms and biomarkers

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1. Unresectable metastatic and advanced colorectal cancer. 2. with sufficient organ function. 3. with written informed consent.
Key exclusion criteria	1. with potent drug affected activity of CYP3A4 or UGT1A9, and with potent drug affected blood concentration of regorafenib. 2. Pregnant female, possibly pregnant females and females feeding babies. 3. with uncontrollable hypertension (systolic >150 mmHg or diastolic >90 mmHg even with hypotensives) 4. with a history of embolism, ischemic heart disease, unstable angina, heart failure or cerebrovascular disease. 5. with severe allergy. 6. Any other patients whom the physician in charge of the study judges to be unsuitable.
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Hiroyuki Middle name Last name Shibata
Organization	Akita University Hospital
Division name	Department of Clinical Oncology
Zip code	018-8543
Address	1-1-1 Hondo, Akita, Japan
TEL	018-884-6261
Email	hiroyuki@med.akita-u.ac.jp

Public contact
Name of contact person	1st name Hiroyuki Middle name Last name Shibata
Organization	Akita University Hospital
Division name	Department of Clinical Oncology
Zip code	018-8543
Address	1-1-1 Hondo, Akita, Japan
TEL	018-884-6262
Homepage URL
Email	minoue@med.akita-u.ac.jp

Sponsor
Institute	Department of Clinical Oncology, Akita University Hospital
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)

IRB Contact (For public release)
Organization	Akita University
Address	Hondo 1-1-1, Akita, Japan
Tel	018-884-6262
Email	hiroyuki@med.akita-u.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	2014 Year 10 Month 10 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	2014 Year 08 Month 13 Day
Date of IRB	2014 Year 08 Month 20 Day
Anticipated trial start date	2014 Year 08 Month 21 Day
Last follow-up date	2017 Year 03 Month 01 Day
Date of closure to data entry	2017 Year 03 Month 01 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information	Prospective exploratory study

Management information
Registered date	2014 Year 10 Month 10 Day
Last modified on	2020 Year 04 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017914