UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015563 |
|---|---|
| Receipt number | 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 | 2021/01/18 23:08:47 |
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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 | Masato |
| Middle name | |
| Last name | Nakamura |
Organization
Aizawa Hospital
Division name
Aizawa Comprehensive Cancer Center
Zip code
390-8510
Address
Honjo 2-5-1, Matsumoto City, Nagano, Japan
TEL
0263-33-8600
geka-dr7@ai-hosp.or.jp
Public contact
Name of contact person
| 1st name | Fujii |
| Middle name | |
| Last name | Masashi |
Organization
Nonprofit Organization Japan Clinical Cancer Research Organization
Division name
Office
Zip code
101-0051
Address
6F Jimbocho Kyowa Bldg. 1-64 Kanda-Jimbocho, Chiyoda-ku, Tokyo, Japan
TEL
03-6811-043
Homepage URL
cc12.dc@jaccro.or.jp
Sponsor or person
Institute
Nonprofit Organization Japan Clinical Cancer Research Organization
Institute
Department
Personal name
Funding Source
Organization
Bayer Yakuhin, Ltd
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Japan Clinical Cancer Research Organization (JACCRO)
Address
6F Jimbocho Kyowa Bldg. 1-64 Kanda-Jimbocho, Chiyoda-ku, Tokyo 101-0051
Tel
03-6811-0433
irb-jaccro@jaccro.or.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
慈泉会相澤病院（長野県）等
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
| 2021 | Year | 01 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018084
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