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

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 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


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

Value
https://center6.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