UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018240 |
|---|---|
| Receipt number | R000021088 |
| Scientific Title | A clinical study on the safety of Hypofractionated Whole Breast Irradiation with Concurrent Boost in Breast conserving therapy |
| Date of disclosure of the study information | 2015/07/10 |
| Last modified on | 2020/03/02 21:28:46 |
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Basic information
Public title
A clinical study on the safety of Hypofractionated Whole Breast Irradiation with Concurrent Boost in Breast conserving therapy
Acronym
A clinical study on the safety of Hypofractionated Whole Breast Irradiation with Concurrent Boost
Scientific Title
A clinical study on the safety of Hypofractionated Whole Breast Irradiation with Concurrent Boost in Breast conserving therapy
Scientific Title:Acronym
A clinical study on the safety of Hypofractionated Whole Breast Irradiation with Concurrent Boost
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 of hypofractionated whole breast irradiation with concurrent boost in breast conserving treatment.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
proportion of acute adverse events
Key secondary outcomes
proportion of late adverse events, 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
| Device,equipment | Maneuver |
Interventions/Control_1
Hypofractionated whole breast irradiation therapy (43.2Gy/18fr) with concurrent boost (50.4Gy/18fr) 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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
Patients must fulfill all of the following conditions
1) clinical stage I, II
2) pathologically proven diagnosis of invasive ductal carcinoma, or specific type of carcinoma
3) positive resection margin or close resection margin within 5mm
4) Aged 20 years old or more
5) breast conserving surgery
6) inserted surgical clips in tumor resection margin or mark indicating the resection margin on the skin
7) whole breast irradiation without regional (supraclavicular or parasternal) nodal irradiation planned
8) no prior radiation therapy to thoracic
9) performance status (ECOG) of 0 or 1
10) written informed consent
11) oriental women with enough fluency in Japanese
Key exclusion criteria
1) Prior invasive non-breast malignancy (except carcinoma in situ) unless disease free for a minimum of 5 years prior to study entry
2) Metachronous or simultaneous bilateral breast cancers
3) Acute infection requiring systemic therapy
4) Body temperature 38 degrees Celsius or more at registration
5) Psychiatric or other condition that would prevent the patient from receiving the protocol therapy
6) Uncontrollable diabetes mellitus or administration of insulin
7) Active or prior history of scleroderma, systemic lupus erythematosus, dermatomyositis, or polymyositis
8) Systemic steroids or immunosuppressant medication
9) Severe heart failure or angina attack or myocardial infarction within the last 6 months
10) Interstitial pneumonia, pulmonary fibrosis, or severe chronic obstructive pulmonary disease
11) Pregnancy, pregnancy potential, after giving birth within 28 days, or lactating
Target sample size
15
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
0753667654
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
0753667654
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
Kyoto University Hospital
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
京都大学医学部附属病院（京都府）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 07 | Month | 10 | 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
| 2015 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2015 | Year | 09 | Month | 24 | Day |
Anticipated trial start date
| 2015 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 09 | Month | 24 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 07 | Month | 07 | Day |
Last modified on
| 2020 | Year | 03 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021088
| Research Plan | |
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| 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 |
