Unique ID issued by UMIN | UMIN000014057 |
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Receipt number | R000016368 |
Scientific Title | Administration of Carboplatin for the urothelial carcinoma patients with impaired renal function |
Date of disclosure of the study information | 2014/06/01 |
Last modified on | 2015/12/24 20:42:33 |
Administration of Carboplatin for the urothelial carcinoma patients with impaired renal function
Administration of Carboplatin for the urothelial carcinoma patients with impaired renal function
Administration of Carboplatin for the urothelial carcinoma patients with impaired renal function
Administration of Carboplatin for the urothelial carcinoma patients with impaired renal function
Japan |
Urothelial carcinoma
Urology |
Malignancy
NO
To study the safety and efficacy of combination chemotherapy using Gemcitabine and Carboplatin in the urothelial carcinoma patients with impaired renal function
Safety,Efficacy
Adverse events / side effects including renal impairment
Progression-free survival
Response rate based on the RECIST criteria
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
A combination chemotherapy using Gemcitabine and Carboplatin
20 | years-old | <= |
90 | years-old | > |
Male and Female
1> Histologically or clinically confirmed urothelial carcinoma
2> Muscle invasive (T2 or more) or metastatic
3> Renal function of 30ml/min =< CCr =<60ml/min
4> Sufficient bone marrow, liver and cardiovascular function
5> Life expectancy of at least 3 months
6> 20-90 years old
7> written informed consent
1. patients with severe bone marrow suppression
2. patients with allergy to any platinum agents including Carboplatin, or Gemcitabine
3. patients during Pregnancy or Lactation, and with the hope of pregnancy
4. patients with severe liver dysfunction
5. patients with severe / uncontrollable infection
6. patients with active Chicken pox infection
7. patients with interstitial pneumonia and pulmonary fibrosis
8 patients who underwent radiation therapy for lung
9. Patients who progressed during prior chemotherapy using Gemcitabine/Carboplatin or Gemcitabine/CDDP
10. Otherwise, patients who are judged to be not eligible by attending doctors.
30
1st name | |
Middle name | |
Last name | Tohru Nakagawa |
The University of Tokyo Hospital
Department of Urology
7-3-1 Hongo Bunkyo-ku Tokyo
03-3815-5411
tohru-tky@umin.org
1st name | |
Middle name | |
Last name | Tohru Nakagawa |
The University of Tokyo Hospital
Department of Urology
7-3-1 Hongo Bunkyo-ku Tokyo
03-3815-5411
tohru-tky@umin.org
The University of Tokyo Hospital
none
Self funding
NO
2014 | Year | 06 | Month | 01 | Day |
Unpublished
Completed
2013 | Year | 01 | Month | 29 | Day |
2013 | Year | 01 | Month | 30 | Day |
2015 | Year | 06 | Month | 18 | Day |
2015 | Year | 12 | Month | 24 | Day |
2014 | Year | 05 | Month | 24 | Day |
2015 | Year | 12 | Month | 24 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016368
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