UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029478 |
|---|---|
| Receipt number | R000033679 |
| Scientific Title | A phase I/II clinical trial of radical radiotherapy using carbon-ion beams with standard adjuvant therapy for early breast cancer |
| Date of disclosure of the study information | 2017/10/10 |
| Last modified on | 2019/10/11 22:28:38 |
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Basic information
Public title
A phase I/II clinical trial of radical radiotherapy using carbon-ion beams with standard adjuvant therapy for early breast cancer
Acronym
Breast Cancer II
Scientific Title
A phase I/II clinical trial of radical radiotherapy using carbon-ion beams with standard adjuvant therapy for early breast cancer
Scientific Title:Acronym
Breast Cancer II
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 efficacy of the treatment for breast cancer with carbon-ion radiotherapy instead of tumor resection.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Adverse reaction of normal tissue within 90 days after starting of the treatment.
Key secondary outcomes
1. Adverse reaction of normal tissue in late phase
2. Local effect (CR rate)
3. Local control rate with recommended dose
4. Breast cosmetic outcomes
5. Progression-free survival period
6. Overall survival period
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 | Maneuver |
Interventions/Control_1
Carbon-ion radiotherapy for breast tumor (no tumor resection). Adjuvant therapy is performed based on the guidelines for breast cancer.
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. Pathologically proven invasive ductal carcinoma or ductal carcinoma in situ.
2. Tumor size <=20 mm on MRI.
3. No massive LVSI or EIC.
4. No lymphenode metastasis (>2 mm). Sentinel lymph node biopsy is performed prior this study.
5. No distant metastasis.
6. Performance status (ECOG) of 0 to 2.
7. 20 years old or older.
8. A life expectancy of at least 6 months.
9. Written informed consent.
Key exclusion criteria
1. Severe complication (e.g. uncontroled lung disease, heart disease, infection, or psychiatric disease).
2. Previous treatment history including surgery, chemotherapy, endocrine therapy, molecular-targeted agents for breast cancer in same side.
3. Active other malignancy
4. The distanse between skin surface and tumor (including EIC) <=5 mm.
5. Previous radiation therapy for breast cancer in same side.
6. Eligible patients for "Breast cancer I".
7. Pregnancy, pregnancy potential.
8. Ptinents who are considered inappropriate by the attending physician due to medical, psychological or other factors.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Kumiko |
| Middle name | |
| Last name | Karasawa |
Organization
National Institutes for Quantum and Radiological Sciences and Technology
Division name
QSTHospital
Zip code
285-8555
Address
Anagawa 4-9-1, Inage-ku 263-8555 Chiba, Japan
TEL
043-206-3306
kkarasaw@twmu.ac.jp
Public contact
Name of contact person
| 1st name | Noriyuki |
| Middle name | |
| Last name | Okonogi |
Organization
National Institutes for Quantum and Radiological Sciences and Technology
Division name
QST Hospital
Zip code
263-8555
Address
Anagawa 4-9-1, Inage-ku 263-8555 Chiba, Japan
TEL
043-206-3306
Homepage URL
okonogi.noriyuki@qst.go.jp
Sponsor or person
Institute
QST Hospital, National Institutes for Quantum and Radiological Sciences and Technology
Institute
Department
Personal name
Funding Source
Organization
QST Hospital, National Institutes for Quantum and Radiological Sciences and Technology
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 Institutes for Quantum and Radiological Sciences and Technology, Certified Review Board
Address
Anagawa 4-9-1, Inage-ku 263-8555 Chiba, Japan
Tel
043-206-3306
okonogi.noriyuki@qst.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
| 2017 | Year | 10 | Month | 10 | 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
| 2017 | Year | 10 | Month | 04 | Day |
Date of IRB
| 2017 | Year | 10 | Month | 04 | Day |
Anticipated trial start date
| 2017 | Year | 10 | Month | 10 | Day |
Last follow-up date
| 2031 | 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
| 2017 | Year | 10 | Month | 09 | Day |
Last modified on
| 2019 | Year | 10 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033679
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