UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016206 |
|---|---|
| Receipt number | R000018796 |
| Scientific Title | A phase I/II clinical trial of radical radiotherapy using proton for early breast cancer |
| Date of disclosure of the study information | 2015/01/13 |
| Last modified on | 2023/07/21 13:30:33 |
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Basic information
Public title
A phase I/II clinical trial of radical radiotherapy using proton for early breast cancer
Acronym
A phase I/II clinical trial of radical radiotherapy using proton for early breast cancer
Scientific Title
A phase I/II clinical trial of radical radiotherapy using proton for early breast cancer
Scientific Title:Acronym
A phase I/II clinical trial of radical radiotherapy using proton for early breast cancer
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 effectiveness of proton therapy for low risk stage I breast cancer,and to find optimal treatment dose.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase I,II
Assessment
Primary outcomes
1.Acute toxicities of normal tissue
2.Local control
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
Proton therapy 60 to 72GyE/10Fr/12days
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
| 50 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
1.Pathologically proven invasive ductal carcinoma(normal type).
2.Tumor size is 2cm or less on MRI.UICC clinical stageI(T1N0M0)
3. No Lymphovascular space invasion(LVSI), No extensive intraductal component(EIC),Estrogen receptor positive.
4.Performance status 0 to 2.
5.Age 50 years old and over.
6.No other life-threatening illness.
7.Surgery is difficult,surgery has denied herself.
8.Written informed consent
Key exclusion criteria
1.Severe complication
2.Previous treatment
3.Active double primary
4.Tumor invasion to skin or chest wall
5.Distance between tumor border to skin less than 1cm on MRI.
6.Previous irradiation at tumor site
7. Non invasive ductal carcinoma (pure DCIS)
8. Medically, psychologically or other reason who are not suitable for candidate.
9. History of connective tissue diseases
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Hiroyasu |
| Middle name | |
| Last name | Tamamura |
Organization
Fukui Prefectural Hospital
Division name
Proton Therapy Center
Zip code
910-8526
Address
2-8-1 Yotsu,Fukui city,Fukui Prefecture,910-8526 Japan
TEL
0776-54-5151
h-tamamura-8e@pref.fukui.lg.jp
Public contact
Name of contact person
| 1st name | Yoshitaka |
| Middle name | |
| Last name | Sato |
Organization
Fukui Prefectural Hospital
Division name
Proton Therapy Center
Zip code
910-8526
Address
2-8-1 Yotsu,Fukui city,Fukui Prefecture,910-8526 Japan
TEL
0776-54-5151
Homepage URL
y-satou-xn@pref.fukui.lg.jp
Sponsor or person
Institute
Fukui Prefectural Hospital
Institute
Department
Personal name
Funding Source
Organization
FukuiPrefecture
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Fukui Prefectural Hospital
Address
2-8-1 Yotsu,Fukui city,Fukui Prefecture,910-8526 Japan
Tel
0776-54-5151
kenbyou@pref.fukui.lg.jp
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
福井県立病院（福井県）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 01 | 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
Open public recruiting
Date of protocol fixation
| 2014 | Year | 10 | Month | 21 | Day |
Date of IRB
| 2014 | Year | 10 | Month | 21 | Day |
Anticipated trial start date
| 2014 | Year | 10 | Month | 21 | Day |
Last follow-up date
| 2027 | Year | 12 | Month | 31 | 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 | 01 | Month | 13 | Day |
Last modified on
| 2023 | Year | 07 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018796
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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