Unique ID issued by UMIN | UMIN000031438 |
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Receipt number | R000035879 |
Scientific Title | A single-arm confirmatory trial of pazopanib in patients with paclitaxel-pretreated primary cutaneous angiosarcoma(JCOG1605, JCOG-PACS) |
Date of disclosure of the study information | 2018/02/23 |
Last modified on | 2018/02/23 09:56:15 |
A single-arm confirmatory trial of pazopanib in patients with paclitaxel-pretreated primary cutaneous angiosarcoma(JCOG1605, JCOG-PACS)
A single-arm confirmatory trial of pazopanib in patients with paclitaxel-pretreated primary cutaneous angiosarcoma(JCOG1605, JCOG-PACS)
A single-arm confirmatory trial of pazopanib in patients with paclitaxel-pretreated primary cutaneous angiosarcoma(JCOG1605, JCOG-PACS)
A single-arm confirmatory trial of pazopanib in patients with paclitaxel-pretreated primary cutaneous angiosarcoma(JCOG1605, JCOG-PACS)
Japan |
Primary cutaneous angiosarcoma which has become refractory or there was intolerance to paclitaxel
Dermatology |
Malignancy
NO
To evaluate the efficacy and safety of pazopanib as the second line treatment in patients with primary cutaneous angiosarcoma which has become refractory or there was intolerance to paclitaxel
Safety,Efficacy
Confirmatory
Phase III
Progression free survival(response evaluation: every 4 weeks)
Overall survival, Response rate, Disease control rate, Adverse events, Sever adverse events
Interventional
Single arm
Non-randomized
Open -no one is blinded
Historical
1
Treatment
Medicine |
A: Pazopanib group(Pazopanib 800mg is taken orally once daily until disease recurrence or progression)
20 | years-old | <= |
85 | years-old | >= |
Male and Female
1) Histologically confirmed primary cutaneous angiosarcoma not associated with lymphedema or radiation.
2) Primary or metastatic lesions. (histological evaluation is not essential for metastatic lesions)
3) Absence of intracranial metastasis
4) Age >= 20 and =< 85
5) ECOG performance status of 0 or 1.
6) Past history of paclitaxel monotherapy as a first line treatment with or without combination of any local treatment (surgery and/or radiation therapy)
7) No past history of any systemic chemotherapy other than paclitaxel
8) Refractory disease or unable to tolerate paclitaxel
9) A Measurable lesion is not required
10) No prior use of antiangiogenic agents
11) Absense of non-healing wound
12) Adequate organ and marrow function as defined below within 14 days prior to enrollment:
a) Absolute neutrophil count >= 1,500 /mm3
b) Hemoglobin >= 9.0 g/dL
c) Platelets >= 10X104 /mm3
d) Total bilirubin =< 2.25 mg/dL
e) AST=< 75 U/L
f) Male:ALT=< 105 U/L, female: ALT=< 57.5 U/L
g) Renal function: serum creatinine =< 1.5 mg/dL, or, if >1.5 mg/dL, calculated creatinine clearance > 50 mL/min
h) PT-INR <= 1.38
i) APTT <= 44.4 sec
j) TSH: 0.5-4.5 microU/mL
k) FT3: 2.0-4.0 pg/mL
l) FT4: 0.9-1.8 ng/dL
m) Left ventricular ejection fraction >= 50%
n) Corrected QT interval <= 480 ms
o) Negative urinary protein, or, if not negative, 24-hour urinary protein excretion <=0.15g
13) Written informed consent
1) Synchronous or metachronous (within 3 years) malignancies except for carcinoma in situ or intramucosal tumors curatively treated with local therapy
2) Active infection requiring systemic therapy
3) Body temperature >= 38 degrees Celsius
4) Pregnant, possible pregnant, or lactating women. Within 28 days after childbirth. Men with favoring gestation of their partners.
5) Severe psychiatric disease
6) Patients who are receiving systemic administration of steroid or other immunosuppressants.
7) Patients with hypertension (>140 mmHg systolic and > 90 mmHg diastolic) that cannot be adequately controlled with antihypertensives.
8) Patients with heart disease as listed below within 6 months prior to enrollment:
a) Percutaneous transluminal coronary angioplasty
b) Myocardial infarction
c) Unstable angina pectoris
d) Coronary artery bypass grafting
e) Symptomatic peripheral arterial disease
f) Patients with cardiac insufficiency of NYHA class3 or 4
9) Patients with massive pleural effusion or paricardial effusion
10) Patients with interstitial lung disease
11) Patients with paralysis of intestine or ileus
12) Parients with active bleeding
13) Parients with cerebrovascular events within 6 months prior to enrollment
14) Parients with pulmonary enbolism within 6 months prior to enrollment
15) Parients with untreated deep vein thrombosis within 6 months prior to enrollment
30
1st name | |
Middle name | |
Last name | Naoya Yamazaki |
National Cancer Center Hospital, Japan
Department of Dermatologic Oncology
Tsukiji 5-1-1, Chuo-ku, Tokyo 1040045, Japan
03-3542-2511
nyamazak@ncc.go.jp
1st name | |
Middle name | |
Last name | Kohei Oashi |
JCOG1605 Coordinating Office
Division of Dermatology, Saitama Cancer Center
780 Komuro, Ina, Kita-adachi-gun, Saitama 362-0806, Japan
048-722-1111
http://www.jcog.jp/
JCOG_sir@ml.jcog.jp
Japan Clinical Oncology Group (JCOG)
National Cancer Center
Other
Japan
NO
北海道大学病院(北海道)
旭川医科大学(北海道)
札幌医科大学(北海道)
筑波大学医学医療系(茨城県)
埼玉医科大学国際医療センター(埼玉県)
埼玉医科大学病院(埼玉県)
国立がん研究センター中央病院(東京都)
東京大学医学部(東京都)
新潟県立がんセンター新潟病院(新潟県)
富山県立中央病院(富山県)
信州大学医学部(長野県)
静岡県立静岡がんセンター(静岡県)
名古屋大学医学部(愛知県)
京都大学医学部附属病院(京都府)
大阪国際がんセンター(大阪府)
福岡大学医学部(福岡県)
九州大学病院(福岡県)
熊本大学医学部(熊本県)
国立病院機構鹿児島医療センター(鹿児島県)
2018 | Year | 02 | Month | 23 | Day |
Unpublished
Open public recruiting
2017 | Year | 12 | Month | 04 | Day |
2018 | Year | 02 | Month | 23 | Day |
2025 | Year | 08 | Month | 23 | Day |
2018 | Year | 02 | Month | 23 | Day |
2018 | Year | 02 | Month | 23 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035879
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