UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059805 |
|---|---|
| Receipt number | R000068384 |
| Scientific Title | Patient-Reported Outcomes in Patients with Metastatic Colorectal Cancer Treated with Fruquintinib: A Prospective Observational Study |
| Date of disclosure of the study information | 2026/03/01 |
| Last modified on | 2025/11/18 09:16:14 |
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Basic information
Public title
Patient-Reported Outcomes in Patients with Metastatic Colorectal Cancer Treated with Fruquintinib: A Prospective Observational Study
Acronym
FRUPRO
Scientific Title
Patient-Reported Outcomes in Patients with Metastatic Colorectal Cancer Treated with Fruquintinib: A Prospective Observational Study
Scientific Title:Acronym
FRUPRO
Region
| Japan |
Condition
Condition
Metastatic colorectal cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To collect and analyze patient-reported outcomes (PROs) during fruquintinib treatment in patients with colorectal cancer, thereby elucidating adverse events and impacts on quality of life from the patient's perspective. This will support individualized treatment selection and dose adjustment, as well as the development of patient-centered supportive care strategies.
Basic objectives2
Others
Basic objectives -Others
Patient reported outcome
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
PRO-CTCAE
Key secondary outcomes
Longitudinal changes in PRO scores during the treatment period
Association between treatment modifications (dose reduction, treatment interruption, or discontinuation) and deterioration in PROs
Time to deterioration (TTD) of health-related quality of life (HRQoL)
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.Histologically confirmed adenocarcinoma originating from the colon or rectum.
2.Unresectable Stage IV or recurrent colorectal cancer.
3.Age 18 years or older at the time of informed consent.
4.ECOG performance status of 0-2.
5.Planned to receive treatment with fruquintinib.
6.Able to complete PRO questionnaires.
Key exclusion criteria
1. Deemed unsuitable for participation in the study at the discretion of the treating physician.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Hiroya |
| Middle name | |
| Last name | Taniguchi |
Organization
Aichi Cancer Center Hospital
Division name
Department of Clinical Oncology
Zip code
464-8681
Address
Kanokoden 1-1, Chikusa-ku, Nagoya, Aichi
TEL
0527626111
hiroya.taniguchi@aichi-cc.jp
Public contact
Name of contact person
| 1st name | Hiroya |
| Middle name | |
| Last name | Taniguchi |
Organization
Aichi Cancer Center Hospital
Division name
Department of Clinical Oncology
Zip code
4648681
Address
Kanokoden 1-1, Chukusa-ku, Nagoya, Aichi
TEL
0527626111
Homepage URL
hiroya.taniguchi@aichi-cc.jp
Sponsor or person
Institute
Aichi Cancer Network
Institute
Department
Personal name
Funding Source
Organization
Takeda
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Aichi Cancer Center Hospital IRB
Address
Kanokoden 1-1, Chikusa-ku, Nagoya, Aichi
Tel
0527626111
irb@aichi-cc.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
愛知県
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 03 | Month | 01 | 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
| 2025 | Year | 11 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2030 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
PRO-CTCAE: The PRO-CTCAE will be used to assess the following symptoms: mouth or throat pain, hoarseness, changes or loss of taste for food or drinks, decreased appetite, vomiting, diarrhea (loose or watery stools), abdominal pain, shortness of breath, swelling of the arms or legs, rash, hand foot syndrome (skin reactions on the hands or feet such as cracking, peeling, redness, or pain), joint pain (including the elbows, knees, shoulders, etc.), fatigue/lack of energy,and anxiety.
A baseline assessment will be performed before initiation of treatment, and symptoms will be collected weekly through the third treatment cycle. A final assessment will be conducted two weeks after treatment completion.
FACT-GP5
FACT-GP5 single item: "I am bothered by side effects of treatment" will be collected concurrently with the PRO-CTCAE.
Management information
Registered date
| 2025 | Year | 11 | Month | 18 | Day |
Last modified on
| 2025 | Year | 11 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068384
