UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006474 |
|---|---|
| Receipt number | 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 11:42:51 |
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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
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
myossy@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Department of Radiation Oncology and Image-applied Therapy, Graduate School of Medicine, Kyoto University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007617
