UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058867 |
|---|---|
| Receipt number | R000067252 |
| Scientific Title | Patient-Reported Outcomes Following Hypo- vs Ultra-Hypofractionated Radiotherapy in Breast-Conserving Therapy: A Prospective Observational Study |
| Date of disclosure of the study information | 2025/09/11 |
| Last modified on | 2025/09/11 11:51:30 |
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Basic information
Public title
Patient-Reported Outcomes Following Hypo- vs Ultra-Hypofractionated Radiotherapy in Breast-Conserving Therapy: A Prospective Observational Study
Acronym
UPBEAT-PRO
Scientific Title
Patient-Reported Outcomes Following Hypo- vs Ultra-Hypofractionated Radiotherapy in Breast-Conserving Therapy: A Prospective Observational Study
Scientific Title:Acronym
UPBEAT-PRO
Region
| Japan |
Condition
Condition
Breast cancer
Classification by specialty
| Breast surgery | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This study aims to compare acute adverse events and quality of life (QOL) after moderate hypofractionated (MHF) and ultra-hypofractionated (UHF) whole-breast irradiation in patients who have undergone breast-conserving surgery, using standardized assessment tools (PRO-CTCAE and CTCAE) from both patient-reported outcome (PRO) and clinician-reported outcome (CRO) perspectives.
Basic objectives2
Others
Basic objectives -Others
To compare PRO-CTCAE and CTCAE assessments of radiation-related symptoms, evaluate longitudinal changes in patient-reported burden, determine the proportion selecting UHF, and generate evidence on the role of patient perspectives in treatment evaluation and decision-making.
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Proportion of patients with PRO-CTCAE-assessed radiation-related skin reactions of moderate or higher severity at any time from treatment initiation to the 7-week post-treatment assessment
Key secondary outcomes
(1)Proportion of patients reporting moderate or higher severity on the PRO-CTCAE for each of the following symptoms at any assessment from treatment initiation to the 7-week post-treatment evaluation: erythema, hyperpigmentation, pruritus, breast swelling/tenderness, skin dryness, pain, and fatigue.
(2)Longitudinal changes in PRO-CTCAE scores for the above symptoms.
(3)Proportion of patients with CTCAE-graded adverse events occurring at any time from treatment initiation to the 7-week post-treatment evaluation.
(4)Distribution of severity grades for each symptom as reported by both PRO-CTCAE and CTCAE.
(5)Proportion of patients who selected ultra-hypofractionated radiotherapy (UHF).
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
| 40 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
1.Female patients aged 40 years or older who have undergone breast-conserving surgery for early breast cancer and are scheduled to receive whole-breast irradiation
2.Female, 40 years of age or older
3.Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
4.Written informed consent obtained from the patient
Key exclusion criteria
1.Patients requiring supraclavicular lymph node irradiation or boost irradiation
2.Patients scheduled to receive conventional fractionated radiotherapy (e.g., 50 Gy in 25 fractions)
3.History of prior radiotherapy to the same site
4.Presence of evident psychiatric disorders or cognitive impairment that may compromise the reliability of responses to questionnaires
5.Presence of comorbidities judged to have a significant impact on study endpoints
6.Determined by the attending physician to be unsuitable or unable to participate in the study
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Masaki |
| Middle name | |
| Last name | Kokubo |
Organization
Kobe City Medical Center General Hospital
Division name
Department of Radiation Oncology
Zip code
650-0047
Address
2-1-1 Minatojima Minamimachi, Chuo-ku, Kobe
TEL
078-302-4321
mkokubo@kcho.jp
Public contact
Name of contact person
| 1st name | Takamasa |
| Middle name | |
| Last name | Mitsuyoshi |
Organization
Kobe City Medical Center General Hospital
Division name
Department of Radiation Oncology
Zip code
650-0047
Address
2-1-1 Minatojima Minamimachi, Chuo-ku, Kobe
TEL
078-302-4321
Homepage URL
mitsu.t@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kobe City Medical Center General Hospital
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kobe City Medical Center General Hospital
Address
2-1-1 Minatojima Minamimachi, Chuo-ku, Kobe
Tel
078-302-4321
rinken@kcho.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
神戸市立医療センター中央市民病院（兵庫県）
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 09 | Month | 11 | 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
| 2025 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2025 | Year | 09 | Month | 03 | Day |
Anticipated trial start date
| 2025 | Year | 09 | Month | 03 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
| 2027 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2028 | Year | 03 | Month | 31 | Day |
Other
Other related information
This study is a prospective observational study of breast-conserving surgery followed by radiotherapy, comparing patients receiving ultrahypofractionated versus moderately hypofractionated regimens, with a primary focus on evaluating patient-reported outcomes (PROs) related to symptoms and treatment burden.
Management information
Registered date
| 2025 | Year | 08 | Month | 22 | Day |
Last modified on
| 2025 | Year | 09 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067252
