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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000003405
Receipt No. R000004128
Scientific Title Safety and efficacy trial of accelerated partial breast irradiation with 3-dimentional conformal radiation therapy for stage 0, 1, and 2 breast cancer
Date of disclosure of the study information 2010/03/30
Last modified on 2010/03/29

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Basic information
Public title Safety and efficacy trial of accelerated partial breast irradiation with 3-dimentional conformal radiation therapy for stage 0, 1, and 2 breast cancer
Acronym APBI with 3D-CRT for breast cancer
Scientific Title Safety and efficacy trial of accelerated partial breast irradiation with 3-dimentional conformal radiation therapy for stage 0, 1, and 2 breast cancer
Scientific Title:Acronym APBI with 3D-CRT for breast cancer
Region
Japan

Condition
Condition breast cancer after breast-preserving surgery
Classification by specialty
Breast surgery Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To confirm safety and efficacy of accelerated partial breast irradiation with 3-dimentional conformal radiation therapy for stage 0, 1, and 2 breast cancer.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase I,II

Assessment
Primary outcomes Frequency and severity of adverse events of radiotherapy
Key secondary outcomes ipsilateral breast recurrence-free survival, relationship of recurrent site of breast and CTV, disease-free survival, overall survival, proportion of deterioration of breast cosmetic outcomes,

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 Accelerated radiation therapy (38.5 Gy/10 fr/ 2 weeks) for partial breat.
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
20 years-old <=
Age-upper limit

Not applicable
Gender Female
Key inclusion criteria 1)clinical stage 0-2 breast cancer with 3 cm or less of histological tumor diameter
2) pathohistological comfirmed non-inasive carcinoma, invasive carcinoma, or specific type excluding squamous cell carcinoma
3)solitary tumor
4)20 years old or more
5) breast-preserving surgery with lumpectomy or segmental mastectomy
6) more than 5mm of surgical margins
7)inserted surgical clips in the surgical margin of the tumor
8)axillary lymph node dissection with level I or II, or histologically negative sentinel lymph nodes. allowance for no axillary dissection in DCIS
9) 3 and less axillary lymph nodes metastases
10) Performance status of 0-2.
11) Written informed consent.
Key exclusion criteria 1) prior radiation therapy against the thoracic.
2) neoadjuvant chemotherapy and/or hormonal therapy
3) Infection with systemic therapy indicated.
4) Scleroderma, systemic lupus erythematosus, dermatomyositis
5) Women during pregnancy
Target sample size 71

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshikazu Kagami
Organization National Cancer Center Hospital
Division name Radiation Oncology Division
Zip code
Address 5-1-1, Tsukiji, Chuo-ku, Tokyo 104-0045, JAPAN
TEL 03-3542-2511
Email

Public contact
Name of contact person
1st name
Middle name
Last name Yoshikazu Kagami
Organization National Cancer Center Hospital
Division name Radiation Oncology Division
Zip code
Address 5-1-1, Tsukiji, Chuo-ku, Tokyo 104-0045, JAPAN
TEL 03-3542-2511
Homepage URL
Email

Sponsor
Institute National Cancer Center Hospital
Institute
Department

Funding Source
Organization no
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
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 国立がんセンター中央病院(東京都)

Other administrative information
Date of disclosure of the study information
2010 Year 03 Month 30 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
2007 Year 10 Month 27 Day
Date of IRB
Anticipated trial start date
2008 Year 01 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
2010 Year 03 Month 29 Day
Last modified on
2010 Year 03 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004128

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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