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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004184
Receipt No. R000005028
Scientific Title Prospective Study of Hypofractionated Partial Breast Irradiation using 3D-Conformal Radiotherapy
Date of disclosure of the study information 2010/09/13
Last modified on 2016/12/26

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Basic information
Public title Prospective Study of Hypofractionated Partial Breast Irradiation using 3D-Conformal Radiotherapy
Acronym 3D-HPBI Trial
Scientific Title Prospective Study of Hypofractionated Partial Breast Irradiation using 3D-Conformal Radiotherapy
Scientific Title:Acronym 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
1st name
Middle name
Last name Yoshikazu Kagami
Organization Showa University, School of Medicine
Division name Radiation Oncology
Zip code
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
1st name
Middle name
Last name Naoto Shikama
Organization Saitama Medical University International Hospital
Division name Radiation Oncology
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications https://www.ncbi.nlm.nih.gov/pubmed/27127160
Number of participants that the trial has enrolled
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. 
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
2010 Year 04 Month 01 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000005028

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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