UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040249 |
|---|---|
| Receipt number | R000045917 |
| Scientific Title | Prospective intervention study of radiation therapy omission after partial mastectomy in invasive breast cancer |
| Date of disclosure of the study information | 2020/05/01 |
| Last modified on | 2022/05/16 15:40:17 |
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Basic information
Public title
Prospective intervention study of radiation therapy omission after partial mastectomy in invasive breast cancer
Acronym
Prospective intervention study of radiation therapy omission after partial mastectomy in invasive breast cancer
Scientific Title
Prospective intervention study of radiation therapy omission after partial mastectomy in invasive breast cancer
Scientific Title:Acronym
Prospective intervention study of radiation therapy omission after partial mastectomy in invasive breast cancer
Region
| Japan |
Condition
Condition
Breast cancer
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the possibility of de-escalation therapy omitting postoperative radiation therapy after conservative surgery in patients with primary invasive breast cancer who have no lymph node metastasis and lymph-vascular invasion and low risk of local recurrence
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence of invasive cancer in the preserved breast (limited to the first recurrence)
Key secondary outcomes
1. Incidence of cancer in the preserved breast
2. Incidence of true recurrence (TR) and new primary lesion (NP)
3. Recurrence-free survival rate
4. Overall survival rate
5. Search for risk factors for ipsilateral breast cancer
(Age, ER status, PgR status, HER2 status, tumor diameter, Nuclear grade)
6. Incidence of contralateral breast cancer
7. Incidence of distant metastases
8. Incidence of local recurrence rate
9. Incidence of symptomatic pneumonitis
10. Incidence rate of symptomatic cardiac dysfunction
11. Incidence and degree of skin disorders
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Omission of radiation therapy 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
1) Histologically diagnosed invasive breast cancer (irrespective of histological type).
2) TNM classification: pT1-T2pN0
3) Partial mastectomy is performed by vertical resection in which lateral stump can be diagnosed.
4) There is no residual cancer on the skin or pectoralis major muscle.
5) Partial mastectomy specimens are pathologically examined at intervals of 5 mm, and an experienced breast pathologist has concluded complete resection (the distance from the lateral stump to the cancer cells is longer than 5 mm).
6) Histologically no lymph-vascular invasion detected.
7) Age at registration is 20 years or older
8) Performance status (ECOG) is 0 or 1.
9) Main organ functions are maintained.
10) Patients have given their consent to participate in the study through the
documents.
Key exclusion criteria
1) Cases of additional resection during surgery(However, registration is possible if the specimen before additional resection can be diagnosed as complete resection)
2) Cases of excisional biopsy
3) Patients who have not undergone standard surgery on lymph nodes
4) BRCA mutation positive cases
5)When the doctor in charge determines that it is inappropriate
Target sample size
600
Research contact person
Name of lead principal investigator
| 1st name | Takayuki |
| Middle name | |
| Last name | Ueno |
Organization
Cancer Institute Hospital of Japanese Foundation for Cancer Research
Division name
Department of Breast Surgical Oncology, Breast Oncology Center
Zip code
1358550
Address
3-8-31, Ariake, Koto-ku, Tokyo
TEL
0335200111
takayuki.ueno@jfcr.or.jp
Public contact
Name of contact person
| 1st name | Takayuki |
| Middle name | |
| Last name | Ueno |
Organization
Cancer Institute Hospital of Japanese Foundation for Cancer Research
Division name
Department of Breast Surgical Oncology, Breast Oncology Center
Zip code
1358550
Address
3-8-31, Ariake, Koto-ku, Tokyo
TEL
0335200111
Homepage URL
takayuki.ueno@jfcr.or.jp
Sponsor or person
Institute
Department of Breast Surgical Oncology, Breast Oncology Center, Cancer Institute Hospital of Japanese Foundation for Cancer Research
Institute
Department
Personal name
Funding Source
Organization
None
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
Medical Research Ethics Review Committee, Japanese Foundation for Cancer Research
Address
3-8-31, Ariake, Koto-ku, Tokyo
Tel
0335200111
med.shinsa@jfcr.or.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
がん研究会有明病院 乳腺センター 乳腺外科（東京都）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 05 | 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
Enrolling by invitation
Date of protocol fixation
| 2020 | Year | 04 | Month | 15 | Day |
Date of IRB
| 2020 | Year | 04 | Month | 15 | Day |
Anticipated trial start date
| 2020 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 04 | Month | 27 | Day |
Last modified on
| 2022 | Year | 05 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045917
| 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 |
