UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030047 |
|---|---|
| Receipt number | R000034310 |
| Scientific Title | International Retrospective Cohort Study of Locoregional and Systemic Therapy in Oligometastatic Breast Cancer |
| Date of disclosure of the study information | 2018/01/01 |
| Last modified on | 2018/11/12 14:50:36 |
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Basic information
Public title
International Retrospective Cohort Study of Locoregional and Systemic Therapy in Oligometastatic Breast Cancer
Acronym
OLIGO-BC1
Scientific Title
International Retrospective Cohort Study of Locoregional and Systemic Therapy in Oligometastatic Breast Cancer
Scientific Title:Acronym
OLIGO-BC1
Region
| Japan | Asia(except Japan) |
Condition
Condition
metastatic breast cancer
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To validate locoregional therapy and systemic therapy in oligometastatic BC by an international retrospective cohort study.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary endpoint is the estimated 5-year OS after the initial diagnosis of oligometastatic BC.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
1 recurrent case performed by curative operation
2 oligometastatic breast cancer defined as in the protocol
3 oligometastatic breast cancer diagnosed between 2005 and 2012
4 systemic therapy or locoregional and systemic therapy performed
5 the order of locoregional therapy and systemic therapy is decided at the physicians discretion
Key exclusion criteria
1 recurrent case with any kind of pleural effusion
2 recurrent case with any kind of ascites beyond a physiological condition
3 recurrent case with any kind of pericardiac effusion
4 recurrent case with a non-curative operation of primary breast cancer, except for cases with a positive surgical margin with noninvasive cancer or cases of sentinel lymph nodes with isolated tumor cells or micrometastases in which axillary lymph node dissection was not performed
5 recurrent case of ipsilateral breast tumor
6 recurrent case with no pathological confirmation of primary breast cancer
7 recurrent case with a past history of other invasive cancer
8 recurrent case with severe or life threatening comorbidity due to myocardial infarction, cerebral infarction, diabetes mellitus, autoimmune disease
Target sample size
700
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shigeru Imoto |
Organization
Kyorin University School of Medicine
Division name
Department of Breast Surgery
Zip code
Address
6-20-2 Shinkawa Mitaka Tokyo
TEL
0422-47-5511
imoto@ks.kyorin-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mami Sakurai |
Organization
FACO (Federation of Asian Clinical Oncology)
Division name
Office
Zip code
Address
+81-3-55420546
TEL
03-5542-0546
Homepage URL
faco-office@jsco.or.jp
Sponsor or person
Institute
FACO (Federation of Asian Clinical Oncology)
Institute
Department
Personal name
Funding Source
Organization
FACO (Federation of Asian Clinical Oncology)
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
Address
Tel
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
| 2018 | Year | 01 | 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
| 2017 | Year | 11 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 06 | Month | 30 | Day |
Date trial data considered complete
| 2019 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2020 | Year | 06 | Month | 30 | Day |
Other
Other related information
o hypothesize that locoregional therapy has more advantage of OS in oligometastatic BC, the 5-year OS rates of cases treated with locoregional and systemic therapy and cases treated with systemic therapy alone are expected to be 50% and 40%, respectively. The estimated sample size is calculated to be the number of 698 cases (349 cases in each group) needed to prove the superiority of survival with a two-sided type I error rate of 5% and a statistical power of 80%. Thus, we need to register 700 cases, i.e., 234 cases each from investigators of KACO, CSCO and JSCO. To confirm the hypothesis, events of 400 cases should be needed.
Management information
Registered date
| 2017 | Year | 11 | Month | 20 | Day |
Last modified on
| 2018 | Year | 11 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034310
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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