UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008357 |
|---|---|
| Receipt number | R000009798 |
| Scientific Title | Combination of Gemcitabine and Paclitaxel for urothelial carcinoma |
| Date of disclosure of the study information | 2012/08/01 |
| Last modified on | 2014/08/06 18:14:53 |
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Basic information
Public title
Combination of Gemcitabine and Paclitaxel for urothelial carcinoma
Acronym
Gemcitabine and Paclitaxel for Urothelial carcinoma
Scientific Title
Combination of Gemcitabine and Paclitaxel for urothelial carcinoma
Scientific Title:Acronym
Gemcitabine and Paclitaxel for Urothelial carcinoma
Region
| Japan |
Condition
Condition
Urothelial carcionoma
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacies and the toxicities of Gemcitabine and Paclitaxel combination regimen for urothelial carcinoma
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
overall survival, disease specific survival, side effect
Key secondary outcomes
tumor size, symptom
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
| Medicine |
Interventions/Control_1
The regimen is triweekly.
Patients receive 200mg/m2 paclitaxel that is administered
by intravenous (IV) infusion on Day 1 and 1,000mg/m2 gemcitabine that is administered by IV infusion on Day 1, 8 and 15.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. written informed consent
2. Urothelial cancer was (must be) confirmed by histological or cytological methods.
3. adjuvant or neoadjuvant setting, locally advanced (T4b, N1-3) or metastatic urothelial cancer who are not eligible for radical surgery
4. Patients had measurable diseases.
5. Regardless of the objectives, CDDP-resistant urothelial cancer or patients who cannot receive cisplatin due to renal dysfunction.
6. PS 0-2
7. Prior chemotherapy with taxan was not allowed.
Key exclusion criteria
1. prior chemotherapy with paclitaxel
2. patients with interstitial pneumoniae and pulmonary fibrosis
3. patients with body fluid with the necessity of drainage or severe edema
4. patients with brain metastasis with the necessity of treatment
5. active double cancer
6. severe or uncontrollable complications
7. patients with allergy to polyoxyethylene castor oil-contain drug (e.g., CDDP) or sclerosing castor oil-contain drug (e.g., injectable vitamins)
8. Not eligible for patients during Pregnancy or Lactation, and with the hope of pregnancy
9. Prior therapy is allowed if this is
completed more than 28 days before study entry.
10. Otherwise, patients are judged to be not eligible by the attending doctor.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masaru Ishida |
Organization
Saiseikai Yokohamashi Tobu Hospital
Division name
Urology
Zip code
Address
3-6-1 Shimosueyoshi, Tsurumi-ku, Yokohama
TEL
045-576-3000
m-ishida@kc5.so-net.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masaru Ishida |
Organization
Saiseikai Yokohamashi Tobu Hospital
Division name
Urology
Zip code
Address
3-6-1 Shimosueyoshi, Tsurumi-ku, Yokohama
TEL
045-576-3000
Homepage URL
m-ishida@kc5.so-net.ne.jp
Sponsor or person
Institute
Saiseikai Yokohamashi Tobu Hospital
Institute
Department
Personal name
Funding Source
Organization
Saiseikai Yokohamashi Tobu Hospital
Organization
Division
Category of Funding Organization
Other
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
| 2012 | Year | 08 | Month | 01 | Day |
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
Terminated
Date of protocol fixation
| 2012 | Year | 05 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 08 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 07 | Month | 05 | Day |
Last modified on
| 2014 | Year | 08 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009798
| Research Plan | |
|---|---|
| Registered date | File name |
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| Registered date | File name |
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