UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000034885
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email cc16ar.dc@jaccro.or.jp

Sponsor
Institute Japan Clinical Cancer Research Organization (JACCRO)
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039770

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.