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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000006474
Receipt No. R000007617
Scientific Title A clinical study on the safety and efficacy of accelerated partial breast irradiation in breast-conserving therapy
Date of disclosure of the study information 2011/12/01
Last modified on 2013/10/04

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Basic information
Public title A clinical study on the safety and efficacy of accelerated partial breast irradiation in breast-conserving therapy
Acronym Accelerated partial breast irradiation in breast-conserving therapy
Scientific Title A clinical study on the safety and efficacy of accelerated partial breast irradiation in breast-conserving therapy
Scientific Title:Acronym Accelerated partial breast irradiation in breast-conserving therapy
Region
Japan

Condition
Condition Breast cancer
Classification by specialty
Breast surgery Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate safety and efficacy of radiation therapy (38.5Gy /10fr /2 weeks) using 3D-CRT to a limited volume around the tumor bed after breast-conserving surgery.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes proportion of grade 3 or higher acute or late adverse events within 2 years.
Key secondary outcomes ipsilateral breast recurrence-free survival, proportion of protocol treatment completion, proportion of deterioration of breast cosmetic outcomes, disease-free survival, overall survival

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment Maneuver
Interventions/Control_1 Radiation therapy (38.5Gy /10fr /2 weeks) to the tumor bed region after breast-conserving surgery
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 Patients must fulfill all of the following conditions
1) clinical stage 0, I, II excluding T3 breast cancer with 3 cm or less histological tumor diameter.
2) Histologically confirmed ductal carcinoma in situ (DCIS), invasive ductal carcinoma, or specific type of carcinoma.
3) No tumor cells within 5 mm from the surgical margin in the histological specimens.
4) Single primary tumor.
5) Aged 40 years old or more.
6) No prior chemotherapy or hormonal therapy.
7) Breast-conserving surgery with lumpectomy or segmental mastectomy. Re-excision is permitted if clips are inserted in the final resection margin.
8) Inserted surgical clips in tumor resection margin.
9) Axillary lymph node dissection with level I or II, or histologically negative sentinel lymph nodes. allowance for no axillary dissection in DCIS
10) Three or less positive axillary lymph nodes including sentinel lymph nodes.
11) No prior radiation therapy against the thoracic.
12) Performance status of 0 or 1.
13) Written informed consent.
14) Asian woman with enough fluency in Japanese.
Key exclusion criteria 1) Simultaneous or metachronous (within 5 years) double cancers.
2) Metachronous or simultaneous bilateral breast cancers
3) Infection with systemic therapy indicated.
4) Body temperature of 38 or more degrees Celsius.
5) Psychosis.
6) Uncontrollable diabetes mellitus or administration of insulin.
7) Scleroderma, systemic lupus erythematosus, dermatomyositis, or polymyositis.
8) Systemic steroids medication.
9) Immunosuppressant for active collagen disease.
10) History of severe heart disease, heart failure, myocardial infarction within 6 months or attack of angina pectoris within 6 months.
11) Interstitial pneumonia, pulmonary fibrosis, or severe emphysema.
12) Women during pregnancy, possible pregnancy or breast-feeding.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masahiro Hiraoka
Organization Graduate school of Medicine, Kyoto University
Division name Department of Radiation Oncology and Image-applied Therapy
Zip code
Address 54 Shogoin Kawaharacho Sakyo-ku, Kyoto
TEL 0757513417
Email hiraok@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Michio Yoshimura
Organization Graduate school of Medicine, Kyoto University
Division name Department of Radiation Oncology and Image-applied Therapy
Zip code
Address 54 Shogoin Kawaharacho Sakyo-ku, Kyoto
TEL 0757513762
Homepage URL
Email myossy@kuhp.kyoto-u.ac.jp

Sponsor
Institute Department of Radiation Oncology and Image-applied Therapy, Graduate School of Medicine, Kyoto University
Institute
Department

Funding Source
Organization Funding Program for World-Leading Innovative R&D on Science and Technology
Organization
Division
Category of Funding Organization
Nationality of Funding Organization JAPAN

Other related organizations
Co-sponsor Mitsubishi heavy industries, Ltd.
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 京都大学医学部附属病院(京都府)

Other administrative information
Date of disclosure of the study information
2011 Year 12 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 No longer recruiting
Date of protocol fixation
2011 Year 11 Month 04 Day
Date of IRB
Anticipated trial start date
2011 Year 12 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

Management information
Registered date
2011 Year 10 Month 04 Day
Last modified on
2013 Year 10 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007617

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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