UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000004184
Receipt number 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 14:25:02

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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 or person

Institute

Health and Labor Sciences Research Grants (H21-018)

Institute

Department

Personal name



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

Value
https://center6.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