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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000014057 |
Receipt No. | 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 |
Basic information | ||
Public title | Administration of Carboplatin for the urothelial carcinoma patients with impaired renal function | |
Acronym | Administration of Carboplatin for the urothelial carcinoma patients with impaired renal function | |
Scientific Title | Administration of Carboplatin for the urothelial carcinoma patients with impaired renal function | |
Scientific Title:Acronym | Administration of Carboplatin for the urothelial carcinoma patients with impaired renal function | |
Region |
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Condition | ||
Condition | Urothelial carcinoma | |
Classification by specialty |
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Classification by malignancy | Malignancy | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | To study the safety and efficacy of combination chemotherapy using Gemcitabine and Carboplatin in the urothelial carcinoma patients with impaired renal function |
Basic objectives2 | Safety,Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase |
Assessment | |
Primary outcomes | Adverse events / side effects including renal impairment |
Key secondary outcomes | Progression-free survival
Response rate based on the RECIST criteria |
Base | |
Study type | Interventional |
Study design | |
Basic design | Single arm |
Randomization | Non-randomized |
Randomization unit | |
Blinding | Open -no one is blinded |
Control | Uncontrolled |
Stratification | |
Dynamic allocation | |
Institution consideration | |
Blocking | |
Concealment |
Intervention | ||
No. of arms | 1 | |
Purpose of intervention | Treatment | |
Type of intervention |
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Interventions/Control_1 | A combination chemotherapy using Gemcitabine and Carboplatin | |
Interventions/Control_2 | ||
Interventions/Control_3 | ||
Interventions/Control_4 | ||
Interventions/Control_5 | ||
Interventions/Control_6 | ||
Interventions/Control_7 | ||
Interventions/Control_8 | ||
Interventions/Control_9 | ||
Interventions/Control_10 |
Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | 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 |
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Key exclusion criteria | 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. |
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Target sample size | 30 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | The University of Tokyo Hospital | ||||||
Division name | Department of Urology | ||||||
Zip code | |||||||
Address | 7-3-1 Hongo Bunkyo-ku Tokyo | ||||||
TEL | 03-3815-5411 | ||||||
tohru-tky@umin.org |
Public contact | |||||||
Name of contact person |
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Organization | The University of Tokyo Hospital | ||||||
Division name | Department of Urology | ||||||
Zip code | |||||||
Address | 7-3-1 Hongo Bunkyo-ku Tokyo | ||||||
TEL | 03-3815-5411 | ||||||
Homepage URL | |||||||
tohru-tky@umin.org |
Sponsor | |
Institute | The University of Tokyo Hospital |
Institute | |
Department |
Funding Source | |
Organization | none |
Organization | |
Division | |
Category of Funding Organization | Self funding |
Nationality of Funding Organization |
Other related organizations | |
Co-sponsor | |
Name of secondary funder(s) |
IRB Contact (For public release) | |
Organization | |
Address | |
Tel | |
Secondary IDs | |
Secondary IDs | NO |
Study ID_1 | |
Org. issuing International ID_1 | |
Study ID_2 | |
Org. issuing International ID_2 | |
IND to MHLW |
Institutions | |
Institutions |
Other administrative information | |||||||
Date of disclosure of the study information |
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Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
Result | |
URL related to results and publications | |
Number of participants that the trial has enrolled | |
Results | |
Results date posted | |
Results Delayed | |
Results Delay Reason | |
Date of the first journal publication of results | |
Baseline Characteristics | |
Participant flow | |
Adverse events | |
Outcome measures | |
Plan to share IPD | |
IPD sharing Plan description |
Progress | |||||||
Recruitment status | Completed | ||||||
Date of protocol fixation |
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Date of IRB | |||||||
Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry |
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Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016368 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |