UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Feasibility Study of Accelerated Partial Breast Irradiation using External Beam Radiotherapy
Title of the study (Brief title)	Feasibility Study of Accelerated Partial Breast Irradiation using External Beam Radiotherapy
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 feasibility of accelerated partial breast irradiation using external beam radiotherapy for early breast cancer patients.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	rate of completion of protocol treatment
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	Maneuver
Interventions/Control_1	accelerated partial breast irradiation using external beam radiotherapy after breast-conserving surgery
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) Clinically tumor diameter is less than or equal to 2 cm. 3) Clinically negative nodes and negative metastases. 3) Negative multicentric disease. 4) Histologically ductal carcinoma. 5) After breast-conserving surgery and insertion of surgical clips in tumor resection margin. 6) Histologically no tumor cells within 5 mm from the surgical margin 7) Negative axillary nodes and/or negative sentinel nodes. 8) Written informed consent.
Key exclusion criteria	1) Patients with operation other than lumpectomy. 2) Patients with non-epithelial breast malignancies such as sarcoma or lymphoma. 3) Patients with proven multicentric disease. 4) Time between final definitive breast procedure to beginning radiotherapy is greater than 8 weeks. 5) Prior non-hormonal therapy for the present breast cancer. 6) Prior ipsilateral breast or thoracic radiotherapy. 7) Patients who are pregnant or lactating. 8) Patients with collagen vascular disease. 9) Patietns with psychiartic or addictive disorders. 10) Other malignancy. 11) Patients with uncontrolled diabetes.
Target sample size	20

Research contact person
Name of lead principal investigator	Ryoichi Yoshimura
Organization	Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University
Division name	Department of Radiation Therapeutics and Oncology
Address	1-5-45 Yushima Bunkyo-ku Tokyo
TEL	03-5803-5311
Email	ysmrmrad@tmd.ac.jp

Public contact
Name of contact person	Ryoichi Yoshimura
Organization	Graduate School of Medical and Dental Sciences,Tokyo Medical and Dental University
Division name	Department of Radiation Therapeutics and Oncology
Address	1-5-45 Yushima Bunkyo-ku Tokyo
TEL	03-5803-5311
Homepage URL
Email	ysmrmrad@tmd.ac.jp

Sponsor
Institute	Department of Radiation Therapeutics and Oncology, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University
Institute
Department

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)

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	東京医科歯科大学医学部附属病院（東京都）

Other administrative information
Date of disclosure of the study information	2015 Year 04 Month 13 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2014 Year 11 Month 01 Day
Anticipated trial start date	2015 Year 04 Month 13 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 04 Month 10 Day
Last modified on	2018 Year 10 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000019826