UMIN-CTR Clinical Trial

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
Email	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
Email	okonogi.noriyuki@qst.go.jp

Sponsor
Institute	National Institutes for Quantum and Radiological Sciences and Technology
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046859