UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051553 |
|---|---|
| Receipt number | R000058811 |
| Scientific Title | A pilot study of hypofractionated nodal irradiation for postoperative breast cancer |
| Date of disclosure of the study information | 2023/07/08 |
| Last modified on | 2023/07/08 03:47:37 |
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Basic information
Public title
A pilot study of hypofractionated nodal irradiation for postoperative breast cancer
Acronym
FRONTIRE
Scientific Title
A pilot study of hypofractionated nodal irradiation for postoperative breast cancer
Scientific Title:Acronym
FRONTIRE
Region
| Japan |
Condition
Condition
Breast cancer
Classification by specialty
| Hematology and clinical oncology | Breast surgery | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the mid-term outcomes of mildly hypofractionated postoperative nodal irradiation for breast cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Acute or subacute adverse events of CTACE grade 2+ occurring within 6 months from radiation therapy completion
Key secondary outcomes
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
Mild hypofractionated postoperative radiation therapy 42.56 Gy in 16 daily fractionations for patients with high-risk breast cancer.
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Postoperative breast cancer patients who meet the indication criteria for adjuvant radiation therapy including chest wall/conserved breast and regional lymph node in Hyogo Cancer Center Breast Cancer Guidelines.
Key exclusion criteria
Patients with malignancy other than breast cancer, infective disease requiring systemic therapy, fever (> 100 F), diabetes mellitus (HbA1c => 7.0 %), lung fibrosis/interstitial lung disease/severe emphysema, active collagen vascular disease, or genetic disorders high-risk for radiation. Patients who are (possibly) pregnant, breast feeding, receiving systemic steroids or immune-suppression therapy, planned to have breast reconstruction surgery, unable to raise her/his arms above shoulders, or receiving radiation therapy including internal mammary node region.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Haruka |
| Middle name | |
| Last name | Uezono |
Organization
Hyogo Cancer Center
Division name
Department of Radiation Oncology
Zip code
673-8558
Address
13-70 Kitaoji-Cho, Akashi
TEL
0789291151
haru770911@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Haruka |
| Middle name | |
| Last name | Uezono |
Organization
Hyogo Cancer Center
Division name
Department of Radiation Oncology
Zip code
673-8558
Address
13-70 Kitaoji-Cho, Akashi
TEL
0789291151
Homepage URL
https://hyogo-cc.jp/about/dept/radiology_therapeutic.html
haru770911@yahoo.co.jp
Sponsor or person
Institute
Hyogo Cancer Center
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
hyogo cancer center
Address
13-70 Kitaoji-Cho, Akashi
Tel
0789291151
haru770911@yahoo.co.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
R23-002
Org. issuing International ID_1
Hyogo Cancer Center
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
兵庫県立がんセンター
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 07 | Month | 08 | 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
| 2023 | Year | 06 | Month | 22 | Day |
Date of IRB
| 2023 | Year | 07 | Month | 03 | Day |
Anticipated trial start date
| 2023 | Year | 07 | Month | 04 | Day |
Last follow-up date
| 2024 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 07 | Month | 08 | Day |
Last modified on
| 2023 | Year | 07 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058811
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
