Unique ID issued by UMIN | UMIN000003260 |
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Receipt number | R000003946 |
Scientific Title | Phase II study of second line chemotherapy with carboplatin and paclitaxel for metastatic melanoma |
Date of disclosure of the study information | 2010/02/26 |
Last modified on | 2011/03/30 16:42:24 |
Phase II study of second line chemotherapy with carboplatin and paclitaxel for metastatic melanoma
Phase II study of second line chemotherapy with carboplatin and paclitaxel for metastatic melanoma
Phase II study of second line chemotherapy with carboplatin and paclitaxel for metastatic melanoma
Phase II study of second line chemotherapy with carboplatin and paclitaxel for metastatic melanoma
Japan |
melanoma
Dermatology | Plastic surgery |
Malignancy
NO
To test the efficacy of combination therapy with carboplatin and paclitaxel in patients with metastatic melanoma
Efficacy
Confirmatory
Pragmatic
Phase II
Efficacy of combination therapy with carboplatin and paclitaxel in patients with metastatic melanoma
Interventional
Single arm
Non-randomized
Open -no one is blinded
Historical
1
Treatment
Medicine |
Anti-cancer drug (combination with carboplatin and paclitaxel)
18 | years-old | <= |
Not applicable |
Male and Female
1. Histopathologically proven melanoma patients.
2. Patients who have unresectable metastasis.
3. At least 4 weeks after dacarbadine-based chemotherapy.
4. Patients who have a life expectancy of more than 3 months.
5. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1
6. Patients whose age is more than 18 years old, regardless of sex.
7. Patients who have given informed consent
8. Patients without severe disorders
-Neutrophilic leukocyte >1,500/mm3,PLT>100,000/mm3
-liver function (AST< 1.5 folds of upper normal limit)
-renal function (Cre<1.5 mg/dl)
1. Patients who have brain metastases which are not controlled by surgery or radiotherapy
2. Patients without myelosuppresion-Neutrophilic leukocyte<1,500/mm3, PLT<100,000/mm3
3. Patients with severe disorders in heart (NYHA Grade 2 or more), lung, liver, kidney or brain.
4. Patients who are pregnant or nursing
5. Patients who are judged inappropriate to be enrolled in this study by the doctor in charge.
40
1st name | |
Middle name | |
Last name | Yukiko Teramoto, M.D. |
Saitama medical university International medical center
Division of Skin Oncology
1397-1 Yamane, Hidaka, Saitama, Japan
1st name | |
Middle name | |
Last name | Yukiko Teramoto, M.D. |
Saitama medical university International medical center
Division of Skin Oncology
y_tera@saitama-med.ac.jp
Division of Skin Oncology, Comprehensive cancer center,
Saitama medical university International medical center
Division of Skin Oncology, Comprehensive cancer center,
Saitama medical university International medical center
Self funding
NO
2010 | Year | 02 | Month | 26 | Day |
Unpublished
Open public recruiting
2010 | Year | 02 | Month | 26 | Day |
2010 | Year | 03 | Month | 01 | Day |
2012 | Year | 03 | Month | 01 | Day |
2010 | Year | 02 | Month | 26 | Day |
2011 | Year | 03 | Month | 30 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003946
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