UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003578 |
|---|---|
| Receipt number | R000004339 |
| Scientific Title | Phase II study of Intraoperative radiation therapy in early breast cancer |
| Date of disclosure of the study information | 2010/05/10 |
| Last modified on | 2023/05/17 09:11:01 |
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Basic information
Public title
Phase II study of Intraoperative radiation therapy in early breast cancer
Acronym
Phase II study of Intraoperative radiation therapy in early breast cancer
Scientific Title
Phase II study of Intraoperative radiation therapy in early breast cancer
Scientific Title:Acronym
Phase II study of Intraoperative radiation therapy in early breast cancer
Region
| Japan |
Condition
Condition
early breast cancer
Classification by specialty
| Breast surgery | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To study efficacy and safety of intraoperative radiation therapy for early breast cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
efficacy (ispirateral local recurrence rate)
Key secondary outcomes
safety, cosmetic evaluation, historical control, evaluation of irradiated volume
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
| Maneuver |
Interventions/Control_1
Intraoperative radiotherapy for breast conservative operation
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) T>2.5cm
2) N0
3) hope for breast conservative operation
4) age older than 50 years
5) marjin is more than 1cm
6) diagnosed marjin is free pathologically intraoperation
7) patologically lymph node negative
8) informed consent is signed
Key exclusion criteria
1) contraindications to radiation therapy
2) past given the radiation therapy for breast or chest
3) have extensive intraductal component
4) have a tumor located in the axillary tail of the breast
Target sample size
140
Research contact person
Name of lead principal investigator
| 1st name | Masataka |
| Middle name | |
| Last name | Sawaki |
Organization
Aichi Cancer Center Hospital
Division name
Breast Oncology
Zip code
464-8681
Address
1-1 Kanokoden, Chikusa-ku, Nagoya
TEL
052-762-6111
m-sawaki@aichi-cc.jp
Public contact
Name of contact person
| 1st name | Masataka |
| Middle name | |
| Last name | Sawaki |
Organization
Aichi Cancer Center Hospital
Division name
Breast Oncology
Zip code
4648681
Address
1-1 Kanokoden, Chikusa-ku, Nagoya
TEL
052-762-6111
Homepage URL
sawapi@qc4.so-net.ne.jp
Sponsor or person
Institute
Aichi Cancer Center Hospital
Institute
Department
Personal name
Funding Source
Organization
Aichi Cancer Center Hospital
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
Aichi Cancer Center
Address
1-1 Kanokoden - Chikusa-ku
Tel
0527626111
irb@aichi-cc.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
愛知県がんセンター（愛知県）、名古屋大学医学部附属病院（愛知県）、群馬県立がんセンター（群馬県）
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 05 | Month | 10 | Day |
Related information
URL releasing protocol
https://pubmed.ncbi.nlm.nih.gov/30993410/
Publication of results
Published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/30993410/
Number of participants that the trial has enrolled
142
Results
In this multicenter phase II study, the rate of IBTR was low and IORT at 21 Gy was feasible in properly selected patients. It is important to use a careful surgical technique to reduce local recurrence because the skin is not included in the radiation field of IORT.
Results date posted
| 2023 | Year | 05 | Month | 17 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The primary endpoint was ipsilateral breast tumor recurrence (IBTR). Key inclusion criteria were T < 2.5 cm, age > 50 years, surgical margin > 1 cm, intraoperative pathologically free margins, and sentinel node negative. After resection of the tumor, radiation at 21 Gy was delivered directly to the mammary gland employing an electron linear accelerator in the operating room, otherwise the patient was transported from the surgical suite to the radiation room.
Participant flow
Overall, 142 patients were enrolled in this study and 129 underwent IORT. Stage 0: n = 4 (3.1%); stage I: n = 98 (76.0%); and stage IIA: n = 27 (20.9%). Luminal type: n = 116 (89.9%); triple-negative: n = 9 (7.0%); and human epidermal growth factor receptor 2: n = 4 (3.1%).
Adverse events
The toxicities included fibrosis in deep-connective tissue: grade 1, 78.1%; wound infection: grade 3, 1.6% and grade 2, 1.6%; and soft tissue necrosis: grade 3, 0.8% and grade 2, 0.8%.
Outcome measures
Recurrence in the breast occurred in four cases; the site of recurrence was just under the skin near the primary tumor site, with similar histology and subtype.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2010 | Year | 04 | Month | 08 | Day |
Date of IRB
| 2010 | Year | 04 | Month | 30 | Day |
Anticipated trial start date
| 2010 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
| 2020 | Year | 04 | Month | 01 | Day |
Date trial data considered complete
| 2020 | Year | 04 | Month | 01 | Day |
Date analysis concluded
| 2020 | Year | 04 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 05 | Month | 07 | Day |
Last modified on
| 2023 | Year | 05 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004339
