UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000041364
Receipt number R000047225
Scientific Title Study to omit irradiation after partial mastectomy with hormone therapy
Date of disclosure of the study information 2020/08/10
Last modified on 2023/08/13 11:14:20

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Basic information

Public title

Study to omit irradiation after partial mastectomy with hormone therapy

Acronym

Breast conserving surgery without irradiation

Scientific Title

Study to omit irradiation after partial mastectomy with hormone therapy

Scientific Title:Acronym

Breast conserving surgery without irradiation

Region

Japan


Condition

Condition

Breast cancer

Classification by specialty

Breast surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

Safe omission of breast irradiation after partial mastectomy for early stage Luminal A breast cancer with detailed pathological search and hormone therapy

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Explanatory

Developmental phase

Phase II


Assessment

Primary outcomes

Proportion of 5-year local recurrence free breasts

Key secondary outcomes

1) Local recurrence rate 2)Distant organ recurrence-free survival rate 3) Regional lymph node recurrence-free survival rate 4) Pathological study of local recurrence 5) Contralateral breast cancer incidence


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

Omission of breast irradiation

Interventions/Control_2

Breast irradiation

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


Not applicable

Age-upper limit


Not applicable

Gender

Female

Key inclusion criteria

1) Case where partial mastectomy was performed 2) Non-invasive breast cancer or invasive cancer with an invasion diameter of 2 cm or less at the final pathological diagnosis 3) Cases where consent was obtained by informed consent

Key exclusion criteria

1) Patients who received drug therapy before surgery 2) Cases that the doctor has determined to be inappropriate

Target sample size

300


Research contact person

Name of lead principal investigator

1st name Masujiro
Middle name
Last name Makita

Organization

Nippon Medical School Musashikosugi Hospital

Division name

Department of breast surgery

Zip code

211-8533

Address

1-396 Kosugi-machi, Nakahara-ku, Kawasaki-shi, Kanagawa 211-8533, Japan.

TEL

0447335181

Email

m-makita@nms.ac.jp


Public contact

Name of contact person

1st name Masujiro
Middle name
Last name Makita

Organization

Nippon Medical School Musashikosugi Hospital

Division name

Department of breast surgery

Zip code

211-8533

Address

1-396 Kosugi-machi, Nakahara-ku, Kawasaki-shi, Kanagawa 211-8533, Japan.

TEL

0447335181

Homepage URL


Email

m-makita@nms.ac.jp


Sponsor or person

Institute

Nippon Medical School

Institute

Department

Personal name



Funding Source

Organization

Nippon Medical School Musashikosugi Hospital

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Ethics committee of Nippon Medical School Musashikosugi Hospital

Address

1-396 Kosugi-machi, Nakahara-ku, Kawasaki-shi, Kanagawa 211-8533, Japan.

Tel

0447335181

Email

eriko@nms.ac.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

日本医科大学武蔵小杉病院


Other administrative information

Date of disclosure of the study information

2020 Year 08 Month 10 Day


Related information

URL releasing protocol


Publication of results

Partially published


Result

URL related to results and publications


Number of participants that the trial has enrolled

131

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

No longer recruiting

Date of protocol fixation

2015 Year 08 Month 31 Day

Date of IRB

2015 Year 09 Month 08 Day

Anticipated trial start date

2015 Year 10 Month 01 Day

Last follow-up date

2027 Year 09 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2020 Year 08 Month 09 Day

Last modified on

2023 Year 08 Month 13 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047225


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name