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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000010977
Receipt No. R000012852
Scientific Title A study on the safety and efficacy of hypofractionated radiotherapy in post-operative irradiation for breast cancer patients
Date of disclosure of the study information 2013/06/17
Last modified on 2015/12/17

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Basic information
Public title A study on the safety and efficacy of hypofractionated radiotherapy in post-operative irradiation for breast cancer patients
Acronym A study of hypofractionated radiotherapy for breast cancer
Scientific Title A study on the safety and efficacy of hypofractionated radiotherapy in post-operative irradiation for breast cancer patients
Scientific Title:Acronym A study of hypofractionated radiotherapy for breast cancer
Region
Japan Asia(except Japan)

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

Objectives
Narrative objectives1 To prove that hypofractionated whole breast irradiation in breast conserving thrapy and hypofractionated post mastectomy regional radiothetapy are as safe and as effective as conventionally fractionated radiotherapy and superior in terms of convenience.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Phase II

Assessment
Primary outcomes Local recurrence-free survival rate (in radiation fields)
Key secondary outcomes Acute adverse events (the skin, subcutaneous tissue, breast tissue, and lungs)
Late advese events (the skin, subcutaneous tissue, breast tissue, lungs, ribs and the heart)
Cosmetic outcome

Base
Study type Interventional

Study design
Basic design Factorial
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 For cases of post breast conserving surgery without high grade factors (age < 50, positive axillary nodes, lymphovascular invasion, or close margins)- 43.2 Gy to the whole breast in 16 fractions over 22 days for (tumor bed boosts are not performed)
Interventions/Control_2 For cases of post breast conserving surgery with positive high grade factors - 43.2 Gy to the whole breast in 16 fractions over 22 days with an additional tumor bed boost of 8.1 Gy in 3 fractions
Interventions/Control_3 For cases of post mastectomy with negative surgical margins - 43.2 Gy to the chest wall and supraclavicular region in 16 fractions over 22 days.
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. Eligibility criteria for HF-WBI
Patient who has undergone BCT and have been histopathologically confirmed to have breast cancer
The size of primary tumor is either Tis, T1 or T2
Patient who has undergone a lymph node dissection (including sentinel lymph node biopsy) and has been histopathologically confirmed to have 3 positive lymph nodes or less.
Consent of the patient for the trial obtained

2. Eligibility criteria for HF-PMRT
Patient who has undergone any type of mastectomy and have been histopathologically confirmed to have breast cancer
Patient without positive margin.
Patient who has undergone a lymph node dissection (including sentinel lymph node biopsy) and has been histopathologically confirmed to have less than 8 positive lymph nodes.
Consent of the patient for the trial obtained
Key exclusion criteria Internal mammary lymph node metastasis.
Residual axillary lymph node or who need to irradiate axially region.
Distant metastasis.
Any active collagen disease
Active double primary cancer (except for carcinoma in situ and bilateral breast cancer)
Concurrent chemoradiotherapy
Previous chest irradiation
Pregnancy and potential pregnancy
Target sample size 400

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kumiko Karasawa
Organization Research Center Hospital for Charged Particle Therapy, National Institute of Radiological Sciences
Division name Treatment Team
Zip code
Address 4-9-1 Anagawa, Inage-ku, Chiba-city,Chiba, Japan
TEL 043-206-3306
Email kkarasaw@nirs.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kumiko Karasawa
Organization Research Center Hospital for Charged Particle Therapy,National Institute of Radiological Sciences
Division name Treatment Team
Zip code
Address 4-9-1 Anagawa, Inage-ku, Chiba-city,Chiba, Japan
TEL 043-206-3306
Homepage URL
Email kkarasaw@nirs.go.jp

Sponsor
Institute National Institute of Radiological Sciences
Institute
Department

Funding Source
Organization National Institute of Radiological Sciences
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs YES
Study ID_1 13-001
Org. issuing International ID_1 National Institute of Radiological Sciences
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions デルタ病院(バングラデシュ)
蘇州大学附属第一医院(中国)
複旦大学上海がんセンター(中国)
インドネシア大学チプト マングンクスモ病院(インドネシア)
ソエトモ総合病院診療センター(インドネシア)
放射線医学総合研究所重粒子医科学センター病院(千葉県)
埼玉医科大学国際医療センター(埼玉県)
弘前大学附属病院(青森県)
群馬大学附属病院(群馬県)
セメイ国立医科大学(カザフスタン)
韓国放射線医科学研究所(韓国)
韓国がんセンター病院(韓国)
サラワク総合病院(マレーシア)
モンゴル国立がんセンター(モンゴル)
聖ルーク医療センター(フィリピン)
フィリピン ホセ・レイエス記念医療センター(フィリピン)
マヒドール大学シリラート病院(タイ)
ホーチミン市腫瘍病院(ベトナム)
国立がんセンター(ベトナム)

Other administrative information
Date of disclosure of the study information
2013 Year 06 Month 17 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
2013 Year 05 Month 17 Day
Date of IRB
Anticipated trial start date
2013 Year 05 Month 17 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
2013 Year 06 Month 17 Day
Last modified on
2015 Year 12 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012852

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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