UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Prospective Study of Hypofractionated Partial Breast Irradiation using 3D-Conformal Radiotherapy
Title of the study (Brief title)	3D-HPBI Trial
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 safe and effectiveness of partial breast irradiation (30 Gy/5 fraction) for early breast cancer
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	2-year late adverse events
Key secondary outcomes	overall survival, disease-free survival, local recurrence-free survival, compliance for treatment, acute adverse events, cosmesis

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	Radiotherapy (Photon and/or electron) 30Gy/5fractions/2wks
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	80 years-old >=
Gender	Female
Key inclusion criteria	Stage 1 partial breast resection axillary resection or sentinel lumph node biopsy were performed invasive ductal carcinoma less than 5.5 cm of the distance clip PS0-1 no privious radiotherapy informed consent
Key exclusion criteria	active double cancer active infection pregnancy mental disorder collagen disease
Target sample size	55

Research contact person
Name of lead principal investigator	Yoshikazu Kagami
Organization	Showa University, School of Medicine
Division name	Radiation Oncology
Address	Hatanodai 1-5-8, Hinagawa-ku, 142-8555 Tokyo Japan
TEL	03-6426-3228
Email	kagami@med.showa-u.ac.jp

Public contact
Name of contact person	Naoto Shikama
Organization	Saitama Medical University International Hospital
Division name	Radiation Oncology
Address	1397-1 Yamane Hidakashi, 350-1298, Japan
TEL	042-984-4111
Homepage URL
Email	nshikama0525@gmail.com

Sponsor
Institute	Health and Labor Sciences Research Grants (H21-018)
Institute
Department

Funding Source
Organization	Health and Labor Sciences Research Grants (H21-018)
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	佐久総合病院（長野県）、埼玉医科大学国際医療センター（埼玉県）、聖路加国際病院（東京都）、都立駒込病院（東京都）

Other administrative information
Date of disclosure of the study information	2010 Year 09 Month 13 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2010 Year 04 Month 01 Day
Anticipated trial start date	2010 Year 05 Month 01 Day
Last follow-up date	2015 Year 12 Month 31 Day
Date of closure to data entry	2015 Year 12 Month 31 Day
Date trial data considered complete	2016 Year 01 Month 01 Day
Date analysis concluded	2016 Year 01 Month 10 Day

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	https://www.ncbi.nlm.nih.gov/pubmed/27127160
Results	Fifty-three patients were treated using photons in the supine position, and two patients received photon and electron beams. Three patients (5%) developed grade 2 symptomatic radiation pneumonitis at 5, 8, and 9 months after 3D-CRT APBI. ILV10Gy should be lower than 10% to avoid symptomatic radiation pneumonitis after 3D-CRT APBI.
Other related information

Management information
Registered date	2010 Year 09 Month 10 Day
Last modified on	2016 Year 12 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000005028