UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041032 |
|---|---|
| Receipt number | R000046859 |
| Scientific Title | Radical radiotherapy using single-fraction carbon-ion beams for early-stage breast cancer: Phase I/II trial |
| Date of disclosure of the study information | 2020/07/27 |
| Last modified on | 2021/02/09 19:16:47 |
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Basic information
Public title
Radical radiotherapy using single-fraction carbon-ion beams for early-stage breast cancer: Phase I/II trial
Acronym
Breast III
Scientific Title
Radical radiotherapy using single-fraction carbon-ion beams for early-stage breast cancer: Phase I/II trial
Scientific Title:Acronym
Breast III
Region
| Japan |
Condition
Condition
breast cancer
Classification by specialty
| Breast surgery | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To determine the safe and effective dose of carbon-ion radiotherapy in single fractionation for early-stage breast cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase I,II
Assessment
Primary outcomes
In phase I:
Acute toxicities of normal tissue
Evaluation of dose limiting toxicities
In phase II:
Primary local effect (non-PD rate)
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
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
Carbon-ion radiotherapy for breast tumor (no tumor resection). Adjuvant therapy is performed based on the guidelines for 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
| 50 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
1.Patholog ically proven ductal carcinoma in situ or invasive ductal carcinoma (usual type)
2.Single lesion, tumor 2 cm or less on MRI: which is classified as Stage 0-I (UICC)
3.No lymphovascular space involvement, no extensive intraductal carcinoma
4.Luminal A like sub type (in case the patient has IDC)
5.Performance status 0 to 2
6.Age 50 years old and over
7.No other life-threatening illness
8.Written informed consent
Key exclusion criteria
1.Severe complication
2.Previous treatment for the breast cancer
3.Active double primary tumor
4.Tumor invasion to skin or chest wall
5.Distance between tumor border to skin less than 5mm
6.Previous irradiation at tumor site
7.Medically, psychologically or other reason who are not suitable for candidate
Target sample size
45
Research contact person
Name of lead principal investigator
| 1st name | Kumiko |
| Middle name | |
| Last name | Karasawa |
Organization
National Institutes for Quantum and Radiological Sciences and Technology
Division name
QST Hospital
Zip code
263-8555
Address
Anagawa 4-9-1, Inage-ku 263-8555 Chiba, Japan
TEL
043-206-3306
kkarasaw@twmu.ac.jp
Public contact
Name of contact person
| 1st name | Noriyuki |
| Middle name | |
| Last name | Okonogi |
Organization
National Institutes for Quantum and Radiological Sciences and Technology
Division name
QST Hospital
Zip code
263-8555
Address
Anagawa 4-9-1, Inage-ku 263-8555 Chiba, Japan
TEL
043-206-3306
Homepage URL
okonogi.noriyuki@qst.go.jp
Sponsor or person
Institute
National Institutes for Quantum and Radiological Sciences and Technology
Institute
Department
Personal name
Funding Source
Organization
National Institutes for Quantum and Radiological Sciences and Technology
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
National Institutes for Quantum and Radiological Sciences and Technology, Certified Review Board
Address
Anagawa 4-9-1, Inage-ku 263-8555 Chiba, Japan
Tel
043-206-3306
okonogi.noriyuki@qst.go.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
量子科学技術研究開発機構 QST病院
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 07 | Month | 27 | 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
| 2020 | Year | 07 | Month | 03 | Day |
Date of IRB
| 2020 | Year | 07 | Month | 03 | Day |
Anticipated trial start date
| 2020 | Year | 07 | Month | 27 | Day |
Last follow-up date
| 2035 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 07 | Month | 08 | Day |
Last modified on
| 2021 | Year | 02 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046859
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