UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000013836
Receipt number R000016147
Scientific Title Phase II study on radiofrequency ablation in stage 0 and I breast cancer without extensive intraductal components
Date of disclosure of the study information 2014/04/30
Last modified on 2014/04/28 19:22:22

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Basic information

Public title

Phase II study on radiofrequency ablation in stage 0 and I breast cancer without extensive intraductal components

Acronym

Phase II study on radiofrequency ablation in stage 0 and I breast cancer

Scientific Title

Phase II study on radiofrequency ablation in stage 0 and I breast cancer without extensive intraductal components

Scientific Title:Acronym

Phase II study on radiofrequency ablation in stage 0 and I breast cancer

Region

Japan


Condition

Condition

breast cancer

Classification by specialty

Breast surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

We conducted a phase II study on radiofrequency ablation in stage 0-I breast cancer without extensive intraductal components to evaluate an alternative to breast-conserving surgery.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Explanatory

Developmental phase

Phase II


Assessment

Primary outcomes

pathological complete ablation rate

Key secondary outcomes

safety of RFA procedure, cosmetic outcome after RFA, 10-year relapse-free survival, 10-year overall survival


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

Device,equipment

Interventions/Control_1

thermal ablation of RFA in breast cancer

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


Not applicable

Age-upper limit


Not applicable

Gender

Female

Key inclusion criteria

1. Written informed consent is obtained.
2. Histologically invasive or noninvasive breast cancer.
3. stage 0 (TisN0M0) or I (T1N0M0 or T1N1miM0).
4. pN0(sn) or pN1mi(sn).
5. Image diagnosis of mammogram, ultrasound, and MR mammogram satisfies the following conditions: tumor with 2cm or less in diameter including extensive intraductal components, tumor not near the nipple-areolar complex, no skin retraction above the tumor, no multifocality, and/or limited microcalcification of the tumor.

Key exclusion criteria

male breast cancer.
bilateral breast cancer.
pregnant women or case with lactating breast.
special type of breast cancer, e.g. lobular carcinoma.

Target sample size

32


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Shigeru Imoto

Organization

School of Medicine Kyorin University

Division name

Department of Breast Surgery

Zip code


Address

6-20-2 Shinkawa Mitaka Tokyo 181-8611, JAPAN

TEL

0422-47-5511

Email

imoto@ks.kyorin-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Shigeru Imoto

Organization

School of Medicine Kyorin University

Division name

Department of Breast Surgery

Zip code


Address

6-20-2 Shinkawa Mmitaka Tokyo 181-8611, JAPAN

TEL

0422-47-5511

Homepage URL


Email

imoto@ks.kyorin-u.ac.jp


Sponsor or person

Institute

Department of Breast Surgery, School of Medicine Kyorin University

Institute

Department

Personal name



Funding Source

Organization

Department of Breast Surgery, School of Medicine Kyorin University

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor

Okinawa Red Cross Hospital
Rinku General Medical Center
National Defense Medical College
Kameda Medical Center

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



Other administrative information

Date of disclosure of the study information

2014 Year 04 Month 30 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

Enrolling by invitation

Date of protocol fixation

2012 Year 10 Month 15 Day

Date of IRB


Anticipated trial start date

2012 Year 12 Month 01 Day

Last follow-up date

2026 Year 04 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2014 Year 04 Month 28 Day

Last modified on

2014 Year 04 Month 28 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016147


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name