UMIN-CTR Clinical Trial

Basic information
Public title	Safety and efficacy evaluation of postoperative whole breast radiotherapy in prone position for Japanese Women
Acronym	Safety and efficacy evaluation of postoperative whole breast radiotherapy in prone position for Japanese Women
Scientific Title	Safety and efficacy evaluation of postoperative whole breast radiotherapy in prone position for Japanese Women
Scientific Title:Acronym	Safety and efficacy evaluation of postoperative whole breast radiotherapy in prone position for Japanese Women
Region	Japan

Condition
Condition	breast cancer
Classification by specialty	Radiology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	This prospective study aimed to analyze the safety and efficacy of whole breast radiotherapy treated in the prone position.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	the frequency and severity of acute radiation toxicities
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Other
Interventions/Control_1	Postoperative whole breast radiotherapy was delivered in the prone position.
Interventions/Control_2	Postoperative whole breast radiotherapy was delivered in the supine position.
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	Not applicable
Gender	Female
Key inclusion criteria	Patients with stage 0-II breast cancer(invasive or non-invasive). Large or pendulous breasts (Japanese bra size C or larger, or the widest measurements of the bust equal to or over 95 cm). Undergoing partial mastectomy in National Cancer Center Hospital. Three or less axillary lymph node metastasis. Written informed consents were obtainted.
Key exclusion criteria	History of irradiation to the ipsilateral breast. Concurrent malignancy. Bilateral breast cancer. Active connective tissue disorders. In pregnancy. Severe infection.
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Yoshikazu Middle name Last name Kagami
Organization	School of Medicine,Showa University
Division name	Department of Radiation Oncology
Zip code	142-0064
Address	1-5-8 Hatanodai, Shinagawa-ku, Tokyo 142-8666, Japan
TEL	03-3784-8000
Email	kagami@med.showa-u.ac.jp

Public contact
Name of contact person	1st name Kana Middle name Last name Takahashi
Organization	National Cancer Center Hospital
Division name	Department of Radiation Oncology
Zip code	104-0045
Address	5-1-1 Tsukiji, Chuo-ku, Tokyo 104-0045, JAPAN
TEL	03-3542-2511
Homepage URL
Email	kantakah@ncc.go.jp

Sponsor
Institute	National Cancer Center Hospital
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)

IRB Contact (For public release)
Organization	Institutional Review Board, National Cancer Cener
Address	5-1-1 Tsukiji, Chuo-ku, Tokyo 104-0045, JAPAN
Tel	03-3542-2511
Email	NCC_IRBoffice@ml.res.ncc.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

Other administrative information
Date of disclosure of the study information	2016 Year 01 Month 23 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications	https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5041564/
Number of participants that the trial has enrolled	22
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	Completed
Date of protocol fixation	2009 Year 08 Month 12 Day
Date of IRB	2009 Year 08 Month 12 Day
Anticipated trial start date	2009 Year 08 Month 12 Day
Last follow-up date	2020 Year 03 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	2016 Year 01 Month 22 Day
Last modified on	2019 Year 07 Month 31 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000023893