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Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000018517
Receipt No. R000021355
Scientific Title Cross over trial of GD and GP therapy in metastatic urothelial carcinoma after the failure of cisplatin-based chemotherapy: randomised phase 3 trials
Date of disclosure of the study information 2015/08/05
Last modified on 2016/09/17

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Basic information
Public title Cross over trial of GD and GP therapy in metastatic urothelial carcinoma after the failure of cisplatin-based chemotherapy: randomised phase 3 trials
Acronym Cross over trial of GD and GP therapy in metastatic urothelial carcinoma
Scientific Title Cross over trial of GD and GP therapy in metastatic urothelial carcinoma after the failure of cisplatin-based chemotherapy: randomised phase 3 trials
Scientific Title:Acronym Cross over trial of GD and GP therapy in metastatic urothelial carcinoma
Region
Japan

Condition
Condition metastatic urothelial carcinoma patients after the failure in the cisplatin-based first line systemic chemotherapy
Classification by specialty
Urology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Urothelial carcinoma (UC) is considered to be a chemosensitive malignancy. Cisplatin-based systemic chemotherapy is regarded as the gold standard regimens for treating patients with advanced or metastatic UC. For more than a decade, the combination regimens of methotrexate, vinblastine, doxorubicin, cisplatin (M-VAC) and methotrexate, epirubicin, cisplatin (MEC) chemotherapy have been held as the standard in treating advanced or metastatic UC patients. Objective response rates of these regimens were approximately 50% in randomized trials. Recently, combined chemotherapy with gemcitabine and cisplatin (GC) has become another standard treatment for advanced UC. However, long-term follow-up results have revealed that overall survival or progression free survival was never satisfactory, particularly with metastatic UC. There is no standard second-line treatment in patients with metastatic UC after failure of platinum-based chemotherapy. Therefore, in the present study, we evaluated the feasibility, toxicity, and efficacy of sequential therapy using Gemcitabine and docetaxel combination regimen, and Gemcitabine and paclitaxel combination regimen in patients with metastatic UC who were refractory to cisplatin-based first-line chemotherapy.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase III

Assessment
Primary outcomes overall survival
Key secondary outcomes adverse event
progression free survival
objective response rate

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation YES
Institution consideration
Blocking
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 GD therapy: gemcitabine 800 mg/m2 administered by a 30 min intravenous infusion on days 1, and 8 and docetaxel 40 mg/m2 also by intravenous infusion on days 1 and 8
Interventions/Control_2 gemcitabine 1000 mg/m2 administered by a 30 min intravenous infusion on days 1, 8, and 15, and paclitaxel 200 mg/m2 also by intravenous infusion on days 1
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
80 years-old >=
Gender Male and Female
Key inclusion criteria Eligible patients had histologically proven metastatic UC of the urinary bladder or upper urinary tract. All of the patients had received surgical treatment or been biopsied for the primary lesions. Also, all had one previous chemotherapy treatment that consisted of M-VAC, MEC, or GC. Previous chemotherapy was completed at least 4 weeks before enrollment. Patients were required to have an Eastern Cooperative Oncology Group performance status (ECOG-PS) of 2 or lower as per the World Health Organization criteria; adequate bone marrow reserve (white blood cell (WBC) count higher than 3,500, platelet count higher than 100,000, and hemoglobin higher than 10 g/dL) was required of all patients. Other requirements were: adequate hepatic function (serum bilirubin 1.5 mg/dl, or less), adequate renal function (serum creatinine 1.5 mg/dl, or measured creatinine clearance of at least 60 ml/min), and an estimated life expectancy of at least 12 weeks. Patients with non-malignant systemic disease that precluded them from receiving therapy, including active infection, any clinically significant cardiac arrhythmia, and/or congestive heart failure, were not eligible. Written informed consent was obtained from all of the patients before this clinical trial.
Key exclusion criteria exclusion criteria patients were below: the patients who had allergy to gemcitabine, and , or taxane derivatives, or patients suspected interstitial lung disease by X ray, or patients who had past history of radiation theapy in chest, or patients suspected infection diseases, or patients who had the possibility of pregnancy, or patients who had uncontrolled cancer diffferent from urothelial cancer.
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Taku Naiki
Organization Nagoya City University Graduate School of Medical Sciences
Division name Department of Nephro-urology
Zip code
Address Kawasumi 1, Mizuho-cho, Mizuho-ku 467-8601, Nagoya, Japan.
TEL 052-853-8266
Email naiki@med.nagoya-cu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Taku Naiki
Organization Nagoya City University Graduate School of Medical Sciences
Division name Department of Nephro-urology
Zip code
Address Kawasumi 1, Mizuho-cho, Mizuho-ku 467-8601, Nagoya, Japan.
TEL 052-853-8266
Homepage URL
Email naiki@med.nagoya-cu.ac.jp

Sponsor
Institute Nagoya City University Graduate School of Medical Sciences
Institute
Department

Funding Source
Organization none
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
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 名古屋市立大学病院

Other administrative information
Date of disclosure of the study information
2015 Year 08 Month 05 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 Open public recruiting
Date of protocol fixation
2015 Year 08 Month 01 Day
Date of IRB
Anticipated trial start date
2015 Year 08 Month 05 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
2015 Year 08 Month 01 Day
Last modified on
2016 Year 09 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021355

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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