UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017097 |
|---|---|
| Receipt number | R000019826 |
| Scientific Title | Feasibility Study of Accelerated Partial Breast Irradiation using External Beam Radiotherapy |
| Date of disclosure of the study information | 2015/04/13 |
| Last modified on | 2018/10/14 12:14:29 |
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Basic information
Public title
Feasibility Study of Accelerated Partial Breast Irradiation using External Beam Radiotherapy
Acronym
Feasibility Study of Accelerated Partial Breast Irradiation using External Beam Radiotherapy
Scientific Title
Feasibility Study of Accelerated Partial Breast Irradiation using External Beam Radiotherapy
Scientific Title:Acronym
Feasibility Study of Accelerated Partial Breast Irradiation using External Beam Radiotherapy
Region
| Japan |
Condition
Condition
breast cancer
Classification by specialty
| Breast surgery | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the feasibility of accelerated partial breast irradiation using external beam radiotherapy for early breast cancer patients.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
rate of completion of protocol treatment
Key secondary 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 partial breast irradiation using external beam radiotherapy 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
1) Clinically tumor diameter is less than or equal to 2 cm.
3) Clinically negative nodes and negative metastases.
3) Negative multicentric disease.
4) Histologically ductal carcinoma.
5) After breast-conserving surgery and insertion of surgical clips in tumor resection margin.
6) Histologically no tumor cells within 5 mm from the surgical margin
7) Negative axillary nodes and/or negative sentinel nodes.
8) Written informed consent.
Key exclusion criteria
1) Patients with operation other than lumpectomy.
2) Patients with non-epithelial breast malignancies such as sarcoma or lymphoma.
3) Patients with proven multicentric disease.
4) Time between final definitive breast procedure to beginning radiotherapy is greater than 8 weeks.
5) Prior non-hormonal therapy for the present breast cancer.
6) Prior ipsilateral breast or thoracic radiotherapy.
7) Patients who are pregnant or lactating.
8) Patients with collagen vascular disease.
9) Patietns with psychiartic or addictive disorders.
10) Other malignancy.
11) Patients with uncontrolled diabetes.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ryoichi Yoshimura |
Organization
Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University
Division name
Department of Radiation Therapeutics and Oncology
Zip code
Address
1-5-45 Yushima Bunkyo-ku Tokyo
TEL
03-5803-5311
ysmrmrad@tmd.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ryoichi Yoshimura |
Organization
Graduate School of Medical and Dental Sciences,Tokyo Medical and Dental University
Division name
Department of Radiation Therapeutics and Oncology
Zip code
Address
1-5-45 Yushima Bunkyo-ku Tokyo
TEL
03-5803-5311
Homepage URL
ysmrmrad@tmd.ac.jp
Sponsor or person
Institute
Department of Radiation Therapeutics and Oncology, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University
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
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
東京医科歯科大学医学部附属病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2015 | 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
Terminated
Date of protocol fixation
| 2014 | Year | 11 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 04 | Month | 13 | 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
| 2015 | Year | 04 | Month | 10 | Day |
Last modified on
| 2018 | Year | 10 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019826
