UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003405 |
|---|---|
| Receipt number | 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 20:40:33 |
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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
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
Sponsor or person
Institute
National Cancer Center Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004128
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
