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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000021237
Receipt No. 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 2017/02/21

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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
Middle name
Last name Jun Itami
Organization National Cancer Center Hospital
Division name Department of Radiation Oncology
Zip code
Address 5-1-1 Tsukiji, Chuo-ku, Tokyo, Japan
TEL 03-3542-2511
Email jitami@ncc.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Ryoichi Yoshimura
Organization Tokyo Medical and Dental University Hospital
Division name Department of Radiation Therapeutics and Oncology
Zip code
Address 1-5-45 Yushima Bunkyo-ku Tokyo
TEL 03-5803-5311
Homepage URL
Email ysmrmrad@tmd.ac.jp

Sponsor
Institute National Cancer Center Hospital
Institute
Department

Funding Source
Organization Japan Agency for Medical Research and Development
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

Other administrative information
Date of disclosure of the study information
2016 Year 05 Month 01 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
2016 Year 02 Month 28 Day
Date of IRB
Anticipated trial start date
2016 Year 05 Month 01 Day
Last follow-up date
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
2017 Year 02 Month 21 Day


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


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