UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016032 |
|---|---|
| Receipt number | R000018604 |
| Scientific Title | Feasibility Study of Accelerated Partial Breast Irradiation using SAVI (Strut Adjusted Volume Implant) |
| Date of disclosure of the study information | 2014/12/22 |
| Last modified on | 2020/01/06 13:57:40 |
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Basic information
Public title
Feasibility Study of Accelerated Partial Breast Irradiation using SAVI (Strut Adjusted Volume Implant)
Acronym
Feasibility Study of Accelerated Partial Breast Irradiation using SAVI (Strut Adjusted Volume Implant)
Scientific Title
Feasibility Study of Accelerated Partial Breast Irradiation using SAVI (Strut Adjusted Volume Implant)
Scientific Title:Acronym
Feasibility Study of Accelerated Partial Breast Irradiation using SAVI (Strut Adjusted Volume Implant)
Region
| Japan |
Condition
Condition
breast cancer
Classification by specialty
| Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the feasibility, safety and cosmesis of accelerated partial breast irradiation using SAVI for early breast cancer patients.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the rate for completion of protocol treatment
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
| Device,equipment |
Interventions/Control_1
accelerated partial breast irradiation using SAVI
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
| 45 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
1. Clinically tumor diameter is less than or equal to 3 cm, and planed to be treated with lumpectomy.
2. Clinically negative nodes and negative metastases.
3. Negative multicentric disease(excluding tumors in different quadrants of the breast, or tumors separated by at least 4 cm)
4. Histologically ductal carcinoma
5. Negative,inked histologic margins of lumpectomy or reexcision specimen to be confirmed prior to introducing the radiation sources. Margins are positive if there is invasive or noninvasive tumor at the inked resection margin.
6. Negative axillary nodes and/or a negative sentinel node. No axillary dissection is needed if pure DCIS.
7. Hormonal manipulation therapy is allowed. Chemotherapy planned for 2 weeks after removal of brachytherapy catheters is permitted.
8. Female
9. Age 45 years or older
10. Written Informed Consent obtained
Key exclusion criteria
1. Patients with operation other than lumpectomy.
2. Patients with pure lobular
3. Patient with nonepithelial breast malignancies such as sarcoma or lymphoma.
4. Patients with proven multicentric disease (tumors in different quadrants of the breast, or tumors separated by at least 4 cm) with other clinically or radiographically suspicious lesions in the ipsilateral breast unless confirmed to be negative for malignancy by biopsy.
5. Patients with lumpectomies so extensive that the cosmetic result is fair or poor prior to brachytherapy.
6. Patients whose lumpectomy cavity is not easily delineated by standard breast imaging or contrast injected into the biopsy cavity.
7. Time between final definitive breast procedure to beginning brachytherapy is greater than 8 weeks.
8. Prior non-hormonal therapy for the present breast cancer, including radiation therapy or chemotherapy.
9. Prior Ipsilateral breast or thoracic RT for any condition.
10. Patients who are pregnant or lactating.
11. Patients with collagen vascular diseases, specifically systemic lupus erythematosis, scleroderma, or dermatomyositis with a CPK level above normal or with an active skin rash.
12. Patients with psychiatric or addictive disorders or other conditions which would preclude obtaining informed consent or completing the full series of brachytherapy treatments on an outpatient basis.
13. Other malignancy, except non-melanoma skin cancer or cervical cancer in-situ, < 5 years prior to participation in this study; the disease free interval from any prior carcinoma must be continuous.
14. Patients with a diagnosis of insulin-dependent diabetes.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Jun |
| Middle name | |
| Last name | Itami |
Organization
National Cancer Center Hospital
Division name
Department of Radiation Oncology
Zip code
1040045
Address
5-1-1 Tsukiji, Chuo-ku, Tokyo
TEL
03-3542-2511
jitami@ncc.go.jp
Public contact
Name of contact person
| 1st name | Kana |
| Middle name | |
| Last name | Takahashi |
Organization
National Cancer Center Hospital
Division name
Department of Radiation Oncology
Zip code
1040045
Address
5-1-1 Tsukiji, Chuo-ku, Tokyo
TEL
03-3542-2511
Homepage URL
kantakah@ncc.go.jp
Sponsor or person
Institute
National Cancer Center Hospital
Institute
Department
Personal name
Funding Source
Organization
none
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
National Cancer Center Hospital
Address
5-1-1 Tsukiji, Chuo-ku, Tokyo
Tel
03-3542-2511
NCC_IRBoffice@ml.res.ncc.go.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
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 12 | Month | 22 | 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
7
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
Completed
Date of protocol fixation
| 2014 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2014 | Year | 06 | Month | 26 | Day |
Anticipated trial start date
| 2014 | Year | 08 | Month | 15 | Day |
Last follow-up date
| 2021 | Year | 03 | 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
| 2014 | Year | 12 | Month | 22 | Day |
Last modified on
| 2020 | Year | 01 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018604
