UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000026976
Receipt number R000030933
Scientific Title Clinical Outcome of Multicatheter Brachytherapy APBI in breast-conserving Therapy (COMBAT) for breast cancer patients after neoadjuvant chemotherapy
Date of disclosure of the study information 2017/04/13
Last modified on 2023/10/19 14:27:54

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Basic information

Public title

Clinical Outcome of Multicatheter Brachytherapy APBI in breast-conserving Therapy (COMBAT) for breast cancer patients after neoadjuvant chemotherapy

Acronym

COMBAT-NEO

Scientific Title

Clinical Outcome of Multicatheter Brachytherapy APBI in breast-conserving Therapy (COMBAT) for breast cancer patients after neoadjuvant chemotherapy

Scientific Title:Acronym

COMBAT-NEO

Region

Japan


Condition

Condition

Breast Cancer

Classification by specialty

Breast surgery Radiology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

Safety and efficacy of accelerated partial breast irradiation using multicatheter brachytherapy followed by breast-conserving surgery will be evaluated in patients with breast cancer after neoadjuvant chemotherapy

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Acute toxicities

Key secondary outcomes

1. long-term cosmesis at 5 years after PBI
2. locoregional and distant recurrences
3. long-term side effectsat 3 months to 5 years after PBI, severities, grades
4. cancer-specific death and other causes


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

Maneuver

Interventions/Control_1

Breast-conserving therapy using multicatheter brachytherapy APBI(4Gyx8fr)

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

1. Histologically confirmed breast cancer
2. Stage I~III
3. Maximum diameter is 3cm or less after chemotherapy
4. Candidate of breast-conserving surgery
5. Female
6. Age is 40 years or older
7. Written informed consent form

Key exclusion criteria

1. Mastectomy
2. Recurrent disease
3. Paget disease
4. Connective tissue disease
5. Pregnancy
6. Inappropriate cases judged by investigators

Target sample size

30


Research contact person

Name of lead principal investigator

1st name Kazuhiko
Middle name
Last name Sato

Organization

Tokyo-West Tokushukai Hospital

Division name

Department of Breast Oncology

Zip code

196-0003

Address

3-1-1 Matsubara, Akishima, Tokyo 196-0003 JAPAN

TEL

+81-570-064-660

Email

kaz.sato@tokushukai.jp


Public contact

Name of contact person

1st name Hiromi
Middle name
Last name Fuchikami

Organization

Tokyo-West Tokushukai Hospital

Division name

Department of Breast Oncology

Zip code

196-0003

Address

3-1-1 Matsubara, Akishima, Tokyo 196-0003 JAPAN

TEL

+81-570-064-660

Homepage URL


Email

sswkw540@gmail.com


Sponsor or person

Institute

Tokyo-West Tokushukai Hospital

Institute

Department

Personal name



Funding Source

Organization

none

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

Mirai Iryou Research Center inc.

Address

1 Chome-8-7 Kojimachi, Chiyoda City, Tokyo 102-0083

Tel

+81-3-3263-4801

Email

mirai-ec1@mirai-iryo.com


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

2017 Year 04 Month 13 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

2017 Year 04 Month 12 Day

Date of IRB

2017 Year 04 Month 06 Day

Anticipated trial start date

2017 Year 04 Month 14 Day

Last follow-up date

2027 Year 04 Month 14 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded

2027 Year 04 Month 14 Day


Other

Other related information



Management information

Registered date

2017 Year 04 Month 13 Day

Last modified on

2023 Year 10 Month 19 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030933


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name