UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000041364
Receipt No. 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 2020/08/09

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Institute Nippon Medical School
Institute
Department

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 Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
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 Open public 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
2020 Year 08 Month 09 Day


Link to view the page
URL(English) https://upload.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


Contact us.