UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000021237
Receipt number R000024499
Scientific Title Brachytherapy using SAVI after breast-conserving surgery for breast cancer patients
Date of disclosure of the study information 2016/05/01
Last modified on 2024/03/05 18:33:17

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Basic information

Public title

Brachytherapy using SAVI after breast-conserving surgery for breast cancer patients

Acronym

SAVI study

Scientific Title

Brachytherapy using SAVI after breast-conserving surgery for breast cancer patients

Scientific Title:Acronym

SAVI study

Region

Japan


Condition

Condition

Breast cancer

Classification by specialty

Breast surgery Radiology Adult

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the outcome of brachytherapy using SAVI.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Local control rate

Key secondary outcomes

Progression free survival rate
Overall survival rate
Complications
Cosmetic evaluation


Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


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

40 years-old <=

Age-upper limit


Not applicable

Gender

Female

Key inclusion criteria

Primary registration
1) Tumor =<3 cm
2) cN0M0
3) Tumor is both unifocal and unicentric
4) Pathologically proven ductal, mucinous, tubular medullary, colloid, or lobular carcinoma
5) No prior history of breast cancer/ no bilateral breast cancer
6) No prior radiotherapy or chemotherapy for this breast cancer
7) Female and >40 years old
8) ECOG performance status 0-1
9) Informed consent was given

Secondary registration
1) Primary registration had been done
2) Breast conserving surgery was performed
3) Pathologically tumor <3 cm
4) Pathologically proven ductal, mucinous, tubular medullary, colloid, or lobular carcinoma after surgery
5) No extensive intraductal component
6) No lympho-vascular invasion
7) Surgical margin was not positive
8) pN0
9) Chemotherapy will be performed over 2 weeks later

Key exclusion criteria

Primary registration
1) Prior history of radiotherapy for chest
2) During pregnancy or lactating
3) Collagen disease
4) Psychiatric comorbidities
5) Prior invasive malignancy unless disease free for a minimum of 5 years
6) Uncontrolled diabetes mellitus
7) Attending physician believes the patient is not suitable for this study

Secondary registration
1) No conserving surgery
2) Paget disease
3) Unsuitable state for brachytherapy
4) Cosmetic evaluation is fair or poor before brachytherapy
5) Duration between surgery and brachytherapy was over 8 weeks

Target sample size

82


Research contact person

Name of lead principal investigator

1st name Jun
Middle name
Last name Itami

Organization

Shin-Matsudo Central General Hospital

Division name

Radiation Therapy Center

Zip code

270-0034

Address

Shin-Matsudo 1-380, Matsudo-City, Chiba Pref.

TEL

047-345-1111

Email

itami.jun@ims.gr.jp


Public contact

Name of contact person

1st name Ryoichi
Middle name
Last name Yoshimura

Organization

Tokyo Medical and Dental University Hospital

Division name

Department of Radiation Therapeutics and Oncology

Zip code

113-8519

Address

1-5-45 Yushima Bunkyo-ku Tokyo

TEL

03-5803-5311

Homepage URL


Email

ysmrmrad@tmd.ac.jp


Sponsor or person

Institute

Tokyo Medical and Dental University

Institute

Department

Personal name



Funding Source

Organization

Self funding

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Tokyo Medical and Dental University

Address

1-5-45, Yushima, Bunkyo-ku, Tokyo

Tel

03-5803-5311

Email

ysmrmrad@tmd.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



Other administrative information

Date of disclosure of the study information

2016 Year 05 Month 01 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

64

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

2016 Year 02 Month 28 Day

Date of IRB

2016 Year 03 Month 18 Day

Anticipated trial start date

2016 Year 05 Month 01 Day

Last follow-up date

2026 Year 05 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

1.Brachytherapy
1)Planning
2)Complication

2. After brachytherapy
1) Outcome
Symptom/ US/ MMG
2) Complication

3. Cosmetic evaluation


Management information

Registered date

2016 Year 02 Month 28 Day

Last modified on

2024 Year 03 Month 05 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024499


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name