UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034885 |
|---|---|
| Receipt number | R000039770 |
| Scientific Title | A biomarker research of "A phase II study of second-line combination therapy with FOLFIRI plus ramucirumab in patients with RAS wild-type unresectable advanced/recurrent colorectal cancer " |
| Date of disclosure of the study information | 2018/11/15 |
| Last modified on | 2018/11/14 10:57:30 |
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Basic information
Public title
A biomarker research of "A phase II study of second-line combination therapy with FOLFIRI plus ramucirumab in patients with RAS wild-type unresectable advanced/recurrent colorectal cancer "
Acronym
JACCRO CC-16AR
Scientific Title
A biomarker research of "A phase II study of second-line combination therapy with FOLFIRI plus ramucirumab in patients with RAS wild-type unresectable advanced/recurrent colorectal cancer "
Scientific Title:Acronym
JACCRO CC-16AR
Region
| Japan |
Condition
Condition
Colorectal cancer
Classification by specialty
| Gastroenterology | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To evaluate associations of a prognosis and the clinical response with the reported biomarkers or new ones in metastatic colorectal cancer patients with RAS wild-type tumors who enrolled a phase II trial of FOLFIRI plus ramucirumab (JACCRO CC-16).
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Association between protein in plasma at pre-treatment and progression-free survival
Key secondary outcomes
- Association between protein in plasma at post-treatment and progression-free survival
- Association between protein in plasma at pre-treatment and response rate or overall survival
- Association between protein in plasma at post-treatment and response rate or overall survival
- Association between novel biomarkers and clinical outcomes
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who were registered in the JACCRO CC-16 trial (jRCTs061180002), include the following:
(1) Approved to supply the tissue sample for this study by IRB.
(2) Written informed consent.
Key exclusion criteria
(1) Patients who were regarded as inadequate for study enrollment by investigators.
(2) Patients who refused to supply the tumor samples.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yu Sunakawa |
Organization
St. Marianna University School of Medicine
Division name
Department of Clinical Oncology
Zip code
Address
2-16-1, Sugao, Miyamae-ku, Kawasaki, Kanagawa, 216-8511, Japan
TEL
044-977-8111
y.sunakawa@marianna-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masashi Fujii |
Organization
Japan Clinical Cancer Research Organization (JACCRO)
Division name
Office
Zip code
Address
7F Ginza Wing Bldg. 1-14-5 Ginza, Chuo-ku, Tokyo 104-0061, Japan
TEL
03-5579-9882
Homepage URL
cc16ar.dc@jaccro.or.jp
Sponsor or person
Institute
Japan Clinical Cancer Research Organization (JACCRO)
Institute
Department
Personal name
Funding Source
Organization
Japan Clinical Cancer Research Organization (JACCRO)
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
University of Southern California(USC), Norris Comprehensive Cancer Center
Name of secondary funder(s)
Eli Lilly Japan K.K
IRB Contact (For public release)
Organization
Address
Tel
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
聖マリアンナ医科大学病院（神奈川県）他
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 11 | Month | 15 | 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
Enrolling by invitation
Date of protocol fixation
| 2018 | Year | 10 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2022 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
| 2023 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2024 | Year | 06 | Month | 30 | Day |
Other
Other related information
To evaluate associations of a prognosis and the clinical response with the reported biomarkers or new ones in metastatic colorectal cancer patients with RAS wild-type tumors who enrolled a phase II trial of FOLFIRI plus ramucirumab (JACCRO CC-16).
Management information
Registered date
| 2018 | Year | 11 | Month | 14 | Day |
Last modified on
| 2018 | Year | 11 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039770
