UMIN-CTR Clinical Trial

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
Email	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
Email	kantakah@ncc.go.jp

Sponsor
Institute	National Cancer Center Hospital
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000018604