UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Investigation of anti-tumoral effect and safety of combination therapy LD-GP (low dose gemcitabine and paclitaxel) therapy and sorafenib in patients with cisplatin-resistant advanced urothelial cancer.
Title of the study (Brief title)	Efficacy and safety of combination therapy of low dose gemcitabine and paclitaxeltherapy with sorafenib in patients with cisplatin-resistant urothelial cancer.
Region	Japan

Condition
Condition	Cisplatin-resistant urothelial cancer
Classification by specialty	Hematology and clinical oncology Urology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To clarify safety.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Frequency of adverse events. Overall survival. Quality of life.
Key secondary outcomes

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	Gemcitabine (700 mg/m2): Day 1. Paclitaxel (70 mg/m2): Day 1. Sorafenib (400mg/day) Day 8 - 21. repeated every 28 days as long as possible.
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	CDDP-resistance. Advanced disease.
Key exclusion criteria	Blood examinations WBC: under 3,000 / mm3. Neut: under 1,500 / mm3. Plt: under 100,000/ mm3. Hgb: under 8 g/dl. T-Bil: over 1.5 mg/dl. s-Cr: over 2.0 mg/dl.
Target sample size	15

Research contact person
Name of lead principal investigator	Hideki Sakai
Organization	Nagasaki University Hospital
Division name	Urology
Address	1-7-1 Sakamoto, Nagasaki
TEL	095-819-7340
Email	hsakai@nagasaki-u.ac.jp

Public contact
Name of contact person	Yasuyoshi Miyata
Organization	Nagasaki University Hospital
Division name	Urology
Address	1-7-1 Sakamoto
TEL	095-819-7340
Homepage URL
Email	int.doc.miya@m3.dion.ne.jp

Sponsor
Institute	Nagasaki University Hospital
Institute
Department

Funding Source
Organization	Urology in Nagasaki University
Organization
Division
Category of Funding Organization	Self funding
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

Other administrative information
Date of disclosure of the study information	2013 Year 06 Month 16 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 03 Month 05 Day
Anticipated trial start date	2013 Year 03 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	Published
URL releasing results
Results
Other related information

Management information
Registered date	2013 Year 06 Month 13 Day
Last modified on	2016 Year 09 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012822