UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056813 |
|---|---|
| Receipt number | R000064935 |
| Scientific Title | An observational / translational study to evaluate outcomes of fruquintinib in clinical practice for patients with metastatic colorectal cancer (FruBLOOM trial) |
| Date of disclosure of the study information | 2025/01/25 |
| Last modified on | 2025/05/30 11:54:04 |
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Basic information
Public title
An observational / translational study to evaluate outcomes of fruquintinib in clinical practice for patients with metastatic colorectal cancer (FruBLOOM trial)
Acronym
JACCRO CC-19
Scientific Title
An observational / translational study to evaluate outcomes of fruquintinib in clinical practice for patients with metastatic colorectal cancer (FruBLOOM trial)
Scientific Title:Acronym
FruBLOOM trial: JACCRO CC-19
Region
| Japan |
Condition
Condition
colorectal cancer
Classification by specialty
| Gastroenterology | Hematology and clinical oncology | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
The study will prospectively evaluate the efficacy and safety of fruquintinib monotherapy administered in clinical practice to treat metastatic colorectal cancer. Efficacy will be examined in the following patients: patients who have not received regorafenib and who receive fruquintinib monotherapy after receiving trifluridine-tipiracil (FTD/TPI) plus bevacizumab [cohort A] and patients who have not received either FTD/TPI +- bevacizumab or regorafenib and who receive fruquintinib monotherapy or patients who receive fruquintinib monotherapy after receiving both FTD/TPI +- bevacizumab and regorafenib (FTD/TPI +- bevacizumab => regorafenib) [cohort B]. In addition, factors related to the efficacy of fruquintinib monotherapy will be explored. Blood will be collected before and after the treatment, and the predictors of fruquintinib monotherapy effectiveness and mechanism of treatment resistance will be investigated.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Overall survival [cohort A]
Key secondary outcomes
Response rate, disease control rate, depth of response, time to response, time to treatment failure, progression-free survival, and safety [cohort A].
Response rate, disease control rate, depth of response, time to response, time to treatment failure, progression-free survival, safety, and overall survival [for cohort B as a whole, for each treatment line, and by previous treatment history].
Progression-free survival and overall survival for post-treatment.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) Colorectal cancer pathologically (biopsy or cytology) confirmed to be adenocarcinoma
(2) All of the following used in previous treatments: fluoropyrimidine, oxaliplatin, irinotecan*1, and angiogenesis inhibitors
However, if the patient has the RAS/BRAF wild type, a BRAF mutation, is HER2 positive, or is MSI-high, the following criteria must be satisfied.
If the RAS/BRAF wild type is present, the patient was previously treated with an anti-EGFR antibody drug.
If a BRAF mutation is present, the patient previously received concomitant BRAF inhibitor therapy.
If the patient is HER2 positive, the patient was previously treated with an anti-HER antibody.
If the patient is MSI-high, the patient was previously administered an immune checkpoint inhibitor.
*1 In cases such as an antibody-drug conjugate (ADC), irinotecan administration may be omitted if the payload is a topoisomerase I inhibitor.
*2 In the case of HER2 positive, anti-EGFR therapy is not required.
*3 In case the patient has the RAS/BRAF mutation, anti-HER2 antibody therapy is not required.
(3) Patients who satisfy any of 1) to 3) below.
1) Recently received FTD/TPI plus bevacizumab therapy and determined to be refractory to or intolerant of this therapy (=> corresponds to cohort A)
2) Previously administered neither regorafenib nor FTD/TPI (=> corresponds to cohort B)
3) Administered regorafenib monotherapy after FTD/TPI +- bevacizumab and determined to be refractory to or intolerant of regorafenib monotherapy (=> corresponds to cohort B)
(4) ECOG Performance Status of 0 to 2
(5) Aged 18 years or older at time of consent
(6) Measurable or evaluable lesions according to RECIST version 1.1
(7) Patients who have given their written consent.
Key exclusion criteria
(1) Has symptomatic or Grade2 or higher interstitial pneumonia or pulmonary fibrosis
(2) History of acute myocardial infarction or acute coronary syndrome (e.g., unstable angina, coronary artery bypass surgery, stent placement) within 6 months (180 days) before enrollment
(3) History of clinically significant congestive heart failure or cardiac arrhythmia within 6 months (180 days) before enrollment or current evidence of such a condition. However, non-symptomatic and/or rate-controlled atrial fibrillation and paroxysmal supraventricular tachycardia are exceptions.
(4) History of a clinically significant thrombotic or cerebrovascular event within 6 months (180 days) before enrollment
(5) Other malignancies
(6) Active infection requiring systemic treatment
(7) Positive for HBs antigen, HCV antibodies, or HIV antibodies
(8) The investigator or a sub-investigator determines that the patient is unsuitable to safely participate in the study.
Target sample size
300
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
2-16-1, Sugao, Miyamae-ku, Kawasaki, Kanagawa
TEL
044-977-8111
y.sunakawa@marianna-u.ac.jp
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
2-16-1, Sugao, Miyamae-ku, Kawasaki, Kanagawa
TEL
044-977-8111
Homepage URL
y.sunakawa@marianna-u.ac.jp
Sponsor or person
Institute
Japan Clinical Cancer Research Organization (JACCRO)
Institute
Department
Personal name
Funding Source
Organization
Takeda Pharmaceutical Company Limited.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
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
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
| 2025 | Year | 01 | Month | 25 | 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
Open public recruiting
Date of protocol fixation
| 2024 | Year | 12 | Month | 24 | Day |
Date of IRB
| 2025 | Year | 01 | Month | 14 | Day |
Anticipated trial start date
| 2025 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study will examine the baseline characteristics, administration status, adverse events during the treatment period, and treatment efficacy in patients with metastatic colorectal cancer who receive fruquintinib monotherapy. In addition, blood samples will be prospectively collected before and after the treatment, and the analysis results and clinical information will be used to investigate biomarkers for fruquintinib monotherapy and the mechanism of resistance to the therapy.
Management information
Registered date
| 2025 | Year | 01 | Month | 25 | Day |
Last modified on
| 2025 | Year | 05 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064935
