Unique ID issued by UMIN | UMIN000005132 |
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Receipt number | R000006103 |
Scientific Title | Phase II study of weekly Vinorelbine and Topotecan administration treatment for refractory adult rhabdomyosarcoma previously treated by VAC regimen. |
Date of disclosure of the study information | 2011/04/01 |
Last modified on | 2011/08/24 09:04:20 |
Phase II study of weekly Vinorelbine and Topotecan administration treatment for refractory adult rhabdomyosarcoma previously treated by VAC regimen.
V-TOP trial
Phase II study of weekly Vinorelbine and Topotecan administration treatment for refractory adult rhabdomyosarcoma previously treated by VAC regimen.
V-TOP trial
Japan |
refractory adult rhabdomyosarcoma previously treated by VAC regimen.
Hematology and clinical oncology |
Malignancy
NO
To identify the efficacy of vinorelbine and topotecan in adult rhabdomyosarcoma
Efficacy
Confirmatory
Explanatory
Phase I,II
Response rate
Adverse event
Progression-free survival
Overall survival
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Topotecan, Vinorelbine
20 | years-old | <= |
Not applicable |
Male and Female
1. Age => 20
2. PS 0-2
3. ECG clinically not significant
4. No clinical signs of ileus, huge ascites
5. Normal bone marrow functions
6. Normal organ function by blood test
7. NO previous treatment of irinotecan, topotecan, and vinorelbine
8. Informed consent available
1. No pregnant
2. No active infections
3. No interstitial pneumonia by X-ray
4. No symptom of brain metastais
5. No HIV positive
6. No grade 3 peripherasl neuropathy
16
1st name | |
Middle name | |
Last name | Masashi Ando |
National Cancer Research Center Hospital
Breast and Medical Oncology Division
5-1-1 Tsukiji, Chuo-ku, Tokyo
03-3542-2511
1st name | |
Middle name | |
Last name | Kenji Hashimoto |
National Cancer Research Center Hospital
Breast and Medical Oncology Division
5-1-1 Tsukiji, Chuo-ku, Tokyo
03-3542-2511
kehashim@ncc.go.jp
National Cancer Research Center Hospital
National Cancer Research Center
Japan
None
None
NO
独立行政法人 国立がん研究センター 中央病院
2011 | Year | 04 | Month | 01 | Day |
Unpublished
Enrolling by invitation
2011 | Year | 03 | Month | 01 | Day |
2011 | Year | 06 | Month | 01 | Day |
2016 | Year | 03 | Month | 01 | Day |
2017 | Year | 03 | Month | 01 | Day |
2017 | Year | 03 | Month | 01 | Day |
2017 | Year | 03 | Month | 01 | Day |
2011 | Year | 02 | Month | 24 | Day |
2011 | Year | 08 | Month | 24 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006103
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