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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000002450
Receipt No. R000002640
Scientific Title Gemcitabine Plus Paclitaxel versus Gemcitabine alone in Patients with Recurrent or Advanced Urothelial Cancer previously Treated With Cisplatin-based Chemotherapy: A randomized Phase II study
Date of disclosure of the study information 2009/10/01
Last modified on 2012/09/28

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Basic information
Public title Gemcitabine Plus Paclitaxel versus Gemcitabine alone in Patients with Recurrent or Advanced Urothelial Cancer previously Treated With Cisplatin-based Chemotherapy: A randomized Phase II study
Acronym Study of GP versus G regimen in patients with cisplatin-refractory urothelial cancer
Scientific Title Gemcitabine Plus Paclitaxel versus Gemcitabine alone in Patients with Recurrent or Advanced Urothelial Cancer previously Treated With Cisplatin-based Chemotherapy: A randomized Phase II study
Scientific Title:Acronym Study of GP versus G regimen in patients with cisplatin-refractory urothelial cancer
Region
Japan

Condition
Condition Urothelial cancer
Classification by specialty
Hematology and clinical oncology Urology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To compare the responsive rate in patients with CDDP-resistant metastatic urothelial cancer treated with gemcitabine/paclitaxel or gemcitabine monotherapy
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes To compare the response rate in patients with CDDP-resistant metastatic urothelial cancer treated with gemcitabine/paclitaxel or gemcitabine monotherapy
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation YES
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 gemcitabine/paclitaxel combination therapy
Interventions/Control_2 gemcitabine monotherapy
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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1. Urothelial cancer was (must be) confirmed by histological or cytological methods. 2. Locally advanced (T4b, N1-3) or metastatic urothelial cancer who are not eligible for radical surgery 3. Patients had measurable diseases. 4. Regardless of the objectives, CDDP-resistant urothelial cancer. 5. PS 0-2 6. Prior chemotherapy with gemcitabine or paclitaxel was not allowed. 7. major organ function were maintained
Key exclusion criteria 1. prior chemotherapy with gemcitabine or 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 80

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shigeo Horie
Organization Teikyo University, School of Medicine
Division name Department of Urology
Zip code
Address 2-11-1, Kaga, Itabashi-ku
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Teikyo University, School of Medicine
Division name Department of Urology
Zip code
Address
TEL
Homepage URL
Email muto@med.teikyo-u.ac.jp

Sponsor
Institute Teikyo University
Institute
Department

Funding Source
Organization Teikyo University
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
Email

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
2009 Year 10 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
2009 Year 07 Month 06 Day
Date of IRB
Anticipated trial start date
2009 Year 07 Month 01 Day
Last follow-up date
2012 Year 06 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2009 Year 09 Month 05 Day
Last modified on
2012 Year 09 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002640

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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