UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045530 |
|---|---|
| Receipt number | R000051983 |
| Scientific Title | Observational Study of BRAF Inhibitor Combination Therapy for BRAF mutant Metastatic Colorectal Cancer including Biomarker Research: BEETS trial(JACCRO CC-18) |
| Date of disclosure of the study information | 2021/09/23 |
| Last modified on | 2021/09/23 15:33:01 |
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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
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
y.sunakawa@marianna-u.ac.jp
Sponsor or person
Institute
JACCRO
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051983
