UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000013242
Receipt No. R000015396
Scientific Title Phase II trial of palliative intra-arterial epirubicin/5FU therapy for patients with chemotherapy-refractory locally-advanced or metastatic breast cancer
Date of disclosure of the study information 2014/02/24
Last modified on 2014/02/24

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Phase II trial of palliative intra-arterial epirubicin/5FU therapy for patients with chemotherapy-refractory locally-advanced or metastatic breast cancer
Acronym JIVROSG-1107(RESAIC-II)
Scientific Title Phase II trial of palliative intra-arterial epirubicin/5FU therapy for patients with chemotherapy-refractory locally-advanced or metastatic breast cancer
Scientific Title:Acronym JIVROSG-1107(RESAIC-II)
Region
Japan

Condition
Condition locally-advanced and metastatic breast cancer
Classification by specialty
Hematology and clinical oncology Breast surgery Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy of intraarterial eprubicin/5FU chemotherapy using implanted catheter-port system as a palliative local treatment in patients with chemotherapy- and radiotherapy-refractory locally advanced and metastatic breast cancer
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes local response rate
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
Medicine Device,equipment
Interventions/Control_1 RESAIC(redistributed subclavian arterial infusion chemotherapy)
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 Male and Female
Key inclusion criteria 1)Patients with symptomatic, locally-inoperable or locally-recurrent invasive breast cancer
2)[Primary breast cancer] Prior treatment with local radiotheraly and more than three prior chemotherapyincluding an anthracycline and a taxane
OR
[Recurrent breast cancer] Prior treatment with local radiotheraly and more than four prior chemotherapy including an anthracycline and a taxane (including neoadjuvant/adjuvant chemotherapy)
3) Cumulative dose of anthracycline (doxorubicin) within 300mg/m2
4) Measurable lesion in the breast or on the chestwall
5) PS (ECOG) 0-2
6) Adequate organ function
7) More than 2 weeks from prior treatment
Key exclusion criteria a)History of non-breast malignancies within the 5 years prior to study entry
b)Symptomatic breast metastasis
c)Concurrent serious diseases that may interfere with planned treatment
d) Stenosis of subclavian artery by contrast-enhanced CT
e) bilateral breast cancer or multiple lesions within the region
f) Pregnant or lactating women
g) Patient unfeasible for ambulatory chemotherapy
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Chikako Shimizu
Organization National Cancer Center Hospital
Division name Breast and Medical Oncology Division
Zip code
Address 5-1-1, Tsukiji, Chuo-ku, Tokyo, Japan
TEL 03-3542-2511
Email cshimizu@ncc.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Miyuki Sone
Organization National Cancer Center Hospital
Division name Department of Radiology
Zip code
Address 5-1-1 Tsukiji, Chuo-ku, Tokyo, Japan
TEL 03-3542-2511
Homepage URL
Email msone@me.com

Sponsor
Institute Japan Interventional Radiology in Oncology Study Group (JIVROSG)
Institute
Department

Funding Source
Organization Grant-in-Aid for Cancer Research from the Ministry of Health, Labor and Welfare and Health Labour Sciences Research Grant.
Organization
Division
Category of Funding Organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 02 Month 24 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
2013 Year 12 Month 03 Day
Date of IRB
Anticipated trial start date
2014 Year 02 Month 18 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2014 Year 02 Month 24 Day
Last modified on
2014 Year 02 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015396

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.