UMIN-CTR Clinical Trial

Basic information
Public title	Observational Study of BRAF Inhibitor Combination Therapy for BRAF mutant Metastatic Colorectal Cancer including Biomarker Research: BEETS trial(JACCRO CC-18)
Acronym	BEETS trial(JACCRO CC-18)
Scientific Title	Observational Study of BRAF Inhibitor Combination Therapy for BRAF mutant Metastatic Colorectal Cancer including Biomarker Research: BEETS trial(JACCRO CC-18)
Scientific Title:Acronym	BEETS trial(JACCRO CC-18)
Region	Japan

Condition
Condition	Colorectal Cancer
Classification by specialty	Gastroenterology Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	To prospectively evaluate the efficacy and safety of combination therapy with BRAF inhibitors in clinical practice for patients with metastatic colorectal cancer with BRAF mutation. The degree to which tumor growth can be controlled by periodic imaging evaluation will be analyzed. In addition, we will compare clinical data of three-drug and two-drug combination therapies to identify factors associated with the benefit of each therapy. Blood samples will be collected before and after treatment, and ctDNA and RNA will be analyzed using next-generation sequencing to identify predictors of efficacy and resistance mechanisms of BRAF inhibitor combination therapy.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Overall survival Relationship between treatment outcomes of BRAF inhibitor combination therapy and genomic data on pretreatment ctDNA and RNA analysis
Key secondary outcomes	Response rate Disease control rate Tumor shrinkage rate Time to response Duration of response Progression-free survival Safety

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	(1) Patients with colorectal cancer confirmed as adenocarcinoma by pathological examination (histology) and BRAF mutation by examination using tumor tissue (2) Patients who will receive BRAF inhibitor combination therapy as second- or third-line treatment (3) Patients with ECOG performance status of 0 to 2 (4) Patients aged 20 years or older (5) Patients with measurable or evaluable lesions by RECISTver1.1
Key exclusion criteria	(1) Patients with interstitial pneumonia or pulmonary fibrosis (2) Patients with a history of acute myocardial infarction or acute coronary syndrome (unstable angina, coronary artery bypass surgery, coronary angioplasty, stenting, etc.) within 6 months prior to enrollment (3) Patients with a history or current evidence of clinically significant congestive heart failure or cardiac arrhythmia within 6 months prior to enrollment (4) Patients with a history of clinically significant thromboembolic or cerebrovascular events within 6 months prior to enrollment (5) Patients with a history of chronic inflammatory bowel disease or Crohn's disease requiring medical intervention (immunomodulatory or immunosuppressive drugs or surgery) within 12 months prior to enrollment (6) Patients with active multiple cancers (7) Patients with active infectious diseases that require systemic treatment (8) Patients with positive HBs antigen, HCV antibody, or HIV antibody (9) Patients judged by the principal investigator or sub-investigator to be inappropriate for the safe conduct of this study
Target sample size	200

Research contact person
Name of lead principal investigator	1st name Yu Middle name Last name Sunakawa
Organization	St. Marianna University School of Medicine
Division name	Department of Clinical Oncology
Zip code	216-8511
Address	Sugao 2-16-1, Miyamae-ku, Kawasaki, Kanagawa
TEL	0449778111
Email	y.suna0825@gmail.com

Public contact
Name of contact person	1st name Yu Middle name Last name Sunakawa
Organization	St. Marianna University School of Medicine
Division name	Department of Clinical Oncology
Zip code	216-8511
Address	Sugao 2-16-1, Miyamae-ku, Kawasaki, Kanagawa
TEL	0449778111
Homepage URL
Email	y.sunakawa@marianna-u.ac.jp

Sponsor
Institute	JACCRO
Institute
Department

Funding Source
Organization	ONO PHARMACEUTICAL CO., LTD.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor	DNA Chip Research Inc.
Name of secondary funder(s)

IRB Contact (For public release)
Organization	IRB of St. Marianna University School of Medicine
Address	Sugao 2-16-1, Miyamae-ku, Kawasaki, Kanagawa
Tel	044-977-8111
Email	k-sienbu.mail@marianna-u.ac.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

Other administrative information
Date of disclosure of the study information	2021 Year 09 Month 23 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	Preinitiation
Date of protocol fixation	2021 Year 08 Month 25 Day
Date of IRB	2021 Year 09 Month 08 Day
Anticipated trial start date	2021 Year 10 Month 01 Day
Last follow-up date	2025 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	nothing special

Management information
Registered date	2021 Year 09 Month 21 Day
Last modified on	2021 Year 09 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051983