Unique ID issued by UMIN | UMIN000013242 |
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Receipt number | 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 17:26:19 |
Phase II trial of palliative intra-arterial epirubicin/5FU therapy for patients with chemotherapy-refractory locally-advanced or metastatic breast cancer
JIVROSG-1107(RESAIC-II)
Phase II trial of palliative intra-arterial epirubicin/5FU therapy for patients with chemotherapy-refractory locally-advanced or metastatic breast cancer
JIVROSG-1107(RESAIC-II)
Japan |
locally-advanced and metastatic breast cancer
Hematology and clinical oncology | Breast surgery | Radiology |
Malignancy
NO
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
Safety,Efficacy
Phase II
local response rate
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine | Device,equipment |
RESAIC(redistributed subclavian arterial infusion chemotherapy)
20 | years-old | <= |
Not applicable |
Male and Female
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
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
30
1st name | |
Middle name | |
Last name | Chikako Shimizu |
National Cancer Center Hospital
Breast and Medical Oncology Division
5-1-1, Tsukiji, Chuo-ku, Tokyo, Japan
03-3542-2511
cshimizu@ncc.go.jp
1st name | |
Middle name | |
Last name | Miyuki Sone |
National Cancer Center Hospital
Department of Radiology
5-1-1 Tsukiji, Chuo-ku, Tokyo, Japan
03-3542-2511
msone@me.com
Japan Interventional Radiology in Oncology Study Group (JIVROSG)
Grant-in-Aid for Cancer Research from the Ministry of Health, Labor and Welfare and Health Labour Sciences Research Grant.
NO
2014 | Year | 02 | Month | 24 | Day |
Unpublished
Open public recruiting
2013 | Year | 12 | Month | 03 | Day |
2014 | Year | 02 | Month | 18 | Day |
2014 | Year | 02 | Month | 24 | Day |
2014 | Year | 02 | Month | 24 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015396
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