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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000015563
Receipt No. R000018084
Scientific Title Phase II study to examine efficacy prediction of Regorafenib with FDG-PET/CT in patients with treatment-refractory metastatic colorectal cancer
Date of disclosure of the study information 2014/11/01
Last modified on 2016/11/15

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Basic information
Public title Phase II study to examine efficacy prediction of Regorafenib with FDG-PET/CT in patients with treatment-refractory metastatic colorectal cancer
Acronym JACCRO CC-12 study
Scientific Title Phase II study to examine efficacy prediction of Regorafenib with FDG-PET/CT in patients with treatment-refractory metastatic colorectal cancer
Scientific Title:Acronym JACCRO CC-12 study
Region
Japan

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

Objectives
Narrative objectives1 To examine change of SUVmax in FDG-PET/CT at 4 weeks after treatment by Regorafenib in patients with standard treatment-refractory metastatic colorectal cancer.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Response rate in change of SUVmax in primary target lesion (the highest value in SUVmax at baseline) at 4 weeks after treatment by Regorafenib.
Key secondary outcomes (1) Response rate in change of SUVmax in target lesion (up to 5 lesions) at 4 weeks after treatment by Regorafenib.
(2) Progression free survival
(3) Overall Survival
(4) Response Rate
(5) Disease control rate
(6) Relationship between change of SUVmax and OS,PFS
(7) AE

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 Regorafenib:160 mg orally, once daily for 3 weeks and one week rest in each cycle.
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) Histologically confirmed colorectal cancer. (2) Metastatic or inoperable locally advanced colorectal cancer(regardless RAS mutation). (3) Measurable lesion by RECIST (Ver.1.1). (4) Evaluable target lesion by FDG-PET/CT. (5) Refractory to fluoronated pyrimidine, oxaliplatin, Irinotecan, bevacizumab, and anti-EGFR antibody therapy. (6) ECOG Performance status 0-1. (7) Age>=20 years old. (8) Life expectancy of more than 3 months. (9) Able to take oral medications. (10)Patients have enough organ function for study treatment within 14 days before enrollment; 1) WBC>= 3,000/mm3, <12,000/mm3. 2) Neu>= 1,500/mm3. 3) PLT>= 100,000/mm3. 4) Hb>= 9.0g/dL. 5) Total bilirubin<= 1.5x ULN. 6) AST<= 2.5x ULN. 7) ALT<= 2.5x ULN. 8) Creatinine<= 1.5x ULN. 9) PT-INR<= 1.5x ULN. (11) Written informed consent.
Key exclusion criteria (1) Synchronous multiple malignancy or metachronous multiple malignancy within 5 years of disease free survival. (2) Serious infection. (3) Following severe comorbidity. 1) Diabetes mellitus required insulin. 2) Uncontrolled hypertension(systolic BP>150mmHg, and/or diastolic BP>90mmHg). 3) Unstable angina,Myocardial infarction,Cerebral infarction,Pulmonary embolism within 6months. 4) Abnormal cardiac rhythm required anti arrhythmic agent. 5) Congestive heart failure(NYHA>=class2). 6) Active or chronic hepatitis B and/or hepatitis C. 7) Active interstitial pneumonia. 8) Hemorrhages(CTCAE>=Grade3) within 4 weeks prior to enrollment. 9) Non-healing wound, ulcer, or bone fracture. (4) Brain metastases. (5) History of treatment by Regorafenib. (6) History of allergy with Regorafenib. (7) Extended field radiotherapy within 4 weeks or local radiotherapy within 2 weeks prior to enrollment. (8) Major surgery, skin-open biopy, severe injury within 4 weeks prior to enrollment. (9) Sustained proteinuria(3+) (10) Men/women who are unwilling to avoid pregnancy. Women who are pregnant or breastfeeding. Women with a positive pregnancy test. (11) Any other cases who are regarded as inadequate for study enrollment by investigators.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masato Nakamura
Organization Aizawa Hospital
Division name Aizawa Comprehensive Cancer Center
Zip code
Address Honjo 2-5-1, Matsumoto City, Nagano
TEL 0263-33-8600
Email geka-dr7@ai-hosp.or.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masashi Fujii
Organization Nonprofit Organization Japan Clinical Cancer Research Organization
Division name Office
Zip code
Address 1-14-5 Ginza, Chuo-ku, Tokyo 104-0061, Japan
TEL 03-5579-9882
Homepage URL
Email cc12.dc@jaccro.or.jp

Sponsor
Institute Nonprofit Organization Japan Clinical Cancer Research Organization
Institute
Department

Funding Source
Organization Nonprofit Organization Japan Clinical Cancer Research Organization
Organization
Division
Category of Funding Organization Non profit foundation
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
2014 Year 11 Month 01 Day

Related information
URL releasing protocol
Publication of results Partially published

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 No longer recruiting
Date of protocol fixation
2014 Year 10 Month 27 Day
Date of IRB
Anticipated trial start date
2014 Year 11 Month 01 Day
Last follow-up date
2017 Year 03 Month 31 Day
Date of closure to data entry
2017 Year 05 Month 30 Day
Date trial data considered complete
2017 Year 06 Month 30 Day
Date analysis concluded
2017 Year 08 Month 31 Day

Other
Other related information

Management information
Registered date
2014 Year 10 Month 30 Day
Last modified on
2016 Year 11 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018084

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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