UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase I/II trial of neoadjuvant intravenous gemcitabine plus intra-arterial cisplatin in muscle-invasive bladder cancer.
Title of the study (Brief title)	Phase I/II trial of neoadjuvant intravenous gemcitabine plus intra-arterial cisplatin in muscle-invasive bladder cancer.
Region	Japan

Condition
Condition	bladder cancer
Classification by specialty	Urology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To examine efficacy and safety of intravenous gemcitabine plus intra-arterial cisplatin in muscle-invasive bladder cancer.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	pathological complete response rate
Key secondary outcomes	clinical response rate progression free survival overall survival bladder preservation rate adverse drug reaction

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	level1 gemcitabine100mg/m2 IV day1,8,15 ciaplatin 70mg/m2 IA day2 q28days 3cycles level2 gemcitabine 100mg/m2 IV day1,8,15 ciaplatin 100mg/m2 IA day2 q28days 3cycles If feasibility of level1 treatment is confirmed, we go to level2.
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	80 years-old >=
Gender	Male and Female
Key inclusion criteria	1. Histologically confirmed muscle invasive bladder cancer (except for small cell carcinoma) 2. Stage(UICC-TNM): pT2a or 2b N0 M0, stage2 pT3a or 3b or 4 N0 M0, stage3 anyT N1orN2 M0, stage4 3. Age: 20 to 80 4. PS (ECOG) 0-1 5.Diagnosised by transurethral resection of bladder tumour (TURBT) and no previous treatment other than TURBT for invasive bladder cancer. 6. No previous surgery (other than TURBT), systemic or intra-arterial chemotherapy or radiation for superficial bladder cancer. 7. Required Initial Laboratory Values: white blood cell count=>4000 cells/mm3 or Absolute neutrophil count=>1500 cells/mm3 Platelets=>100,000 cells/mm3 Aspartate transaminase (AST) and alanine transaminase (ALT) =<1.5 x ULN for the institution or60IU/L Bilirubin =<1.5 mg/dL Alkaline phosphatase=<2.5 x ULN for the institution Serum creatinine=<1.5 mg/dL EKG: normal or minor changes NYHA class1 8. written informed consent provided
Key exclusion criteria	1. women who are pregnant, possibly pregnant or lactating 2.pleural effusion, peritoneal effusion or pericardial effusion which need emergency treatment 3.presence of active infection 4.presence of active double cancer 5.history of drug hypersensitivity reaction 6.presence of severe complication 7.presence of bilateral hydronephrosis (other than the case which was treated by ureteral stent or nephrostomy ) 8.patients inapprppriate for the study entry determined by a doctor
Target sample size	20

Research contact person
Name of lead principal investigator	Ryoji Kimata
Organization	Nippon Medical School Musashokosugi Hospital
Division name	Department of Urology
Address	1-396 Kosugi-machi, Nakahara-ku, Kawasaki city, Kanagawa
TEL	044-733-5181
Email	s2027@nms.ac.jp

Public contact
Name of contact person	Hitomi Sakai
Organization	Nippon Medical School Musashokosugi Hospital
Division name	Department of Medical Oncology
Address	1-396 Kosugi-machi, Nakahara-ku, Kawasaki city, Kanagawa
TEL	044-733-5181
Homepage URL
Email	hitomisakai@nms.ac.jp

Sponsor
Institute	Nippon Medical School Musashokosugi Hospital
Institute
Department

Funding Source
Organization	None
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	2014 Year 04 Month 04 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2014 Year 02 Month 11 Day
Anticipated trial start date	2014 Year 04 Month 07 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	2014 Year 04 Month 04 Day
Last modified on	2019 Year 01 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015913