UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Cross over trial of GD and GP therapy in metastatic urothelial carcinoma after the failure of cisplatin-based chemotherapy: randomised phase 3 trials
Title of the study (Brief title)	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	Taku Naiki
Organization	Nagoya City University Graduate School of Medical Sciences
Division name	Department of Nephro-urology
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	Taku Naiki
Organization	Nagoya City University Graduate School of Medical Sciences
Division name	Department of Nephro-urology
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)

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

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2015 Year 08 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000021355