UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047080 |
|---|---|
| Receipt number | R000053655 |
| Scientific Title | Ultra-hypofractionated Breast Radiotherapy After Breast-Conserving Surgery for Early-Stage Breast Cancer |
| Date of disclosure of the study information | 2022/03/07 |
| Last modified on | 2024/09/04 19:03:36 |
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Basic information
Public title
Ultra-hypofractionated Breast Radiotherapy After Breast-Conserving Surgery for Early-Stage Breast Cancer
Acronym
UPBEAT study
Scientific Title
Ultra-hypofractionated Breast Radiotherapy After Breast-Conserving Surgery for Early-Stage Breast Cancer
Scientific Title:Acronym
UPBEAT study
Region
| Japan |
Condition
Condition
Breast Cancer
Classification by specialty
| Breast surgery | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety of ultra-hypofractionated whole breast adjuvant radiotherapy for breast cancer after breast conservation surgery(26 Gy in 5 fractions)
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence rate of late adverse events within 3 years
Key secondary outcomes
Overall survival, Progression-free survival, Ipsilateral breast tumour recurrence free survival, Ipsilateral breast tumour recurrence free rates, Incidence rate of acute adverse events within 3 months, Incidence rate of late adverse events within 5 years.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Ultra-hypofractionated whole breast adjuvant radiotherapy is given over 5 days (26 Gy in 5 fractions)
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. No distant metastasis confirmed via all exam before surgery
2. After breast-conserving surgery
3. Pathological findings fulfill all of the following conditions:
i. invasive carcinoma or ductal carcinoma in situ
ii. pathological stage review is indicated in pTis-3pN0-1
iii. no tumor exposure to excision margin
4. Within 70 days from surgery in case without adjuvant chemotherapy, and within 42 days from the latest chemotherapy in case with adjuvant chemotherapy
5. Asian woman with enough fluency in Japanese
6. >=40 years of age
7. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
8. No prior radiation therapy against the thoracic
9. Written informed consent
Key exclusion criteria
1. Prior malignancies; except another malignancy and disease-free for > 5 years, or completely resected or successfully treated in situ carcinoma.
2. Infection with systemic therapy indicated
3. Body temperature of 38 or more degrees Celsius
4. Women during pregnancy, possible pregnancy or breast-feeding
5. Psychosis
6. Uncontrollable diabetes mellitus or administration of insulin
7. Interstitial pneumonia, pulmonary fibrosis, or severe emphysema.
8. Systemic steroids medication.
9. Immunosuppressant for active collagen disease.
10. History of severe heart disease, heart failure, myocardial infarction within 6 months or attack of angina pectoris within 6 months.
11. The patient inappropriate for entry into this study.
Target sample size
98
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)
京都大学医学部附属病院 (京都府)
滋賀県立総合病院 (滋賀県)
京都市立病院 (京都府)
京都桂病院 (京都府)
京都岡本記念病院 (京都府)
音羽病院 (京都府)
市立長浜病院 (滋賀県)
大阪赤十字病院 (大阪府)
県立尼崎総合医療センター (兵庫県)
日赤和歌山医療センター (和歌山県)
福井赤十字病院 (福井県)
静岡市立静岡病院 (静岡県)
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 03 | Month | 07 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
105
Results
Interim analysis:
Between May and December 2022,28 patients from 7 institutes were enrolled.
Acute adverse events within 3 months: dermatitis of Grade 2 occurred in 1 patient
Ultra-HF-WBI is considered to be within the acceptable limits for Japanese women in terms of acute toxicities.
Results date posted
| 2024 | Year | 09 | Month | 04 | Day |
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
No longer recruiting
Date of protocol fixation
| 2022 | Year | 02 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 03 | Month | 02 | Day |
Anticipated trial start date
| 2022 | Year | 03 | Month | 04 | Day |
Last follow-up date
| 2029 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Clinical trial notes
Mitsuyoshi T, Ono Y, Ashida R, Yamashita M, Tanabe H, Takebe S, Tokiwa M, Suzuki E, Imagumbai T, Yoshimura M, Yamauchi C, Mizowaki T, Kokubo M. Multi-institutional phase II study of ultra-hypofractionated whole-breast irradiation after breast-conserving surgery for breast cancer in Japan: Kyoto Radiation Oncology Study Group (UPBEAT study). Jpn J Clin Oncol. 2023 Jan 28;53(2):174-178. doi: 10.1093/jjco/hyac174. PMID: 36420578; PMCID: PMC9885732.
Management information
Registered date
| 2022 | Year | 03 | Month | 04 | Day |
Last modified on
| 2024 | Year | 09 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053655
