UMIN-CTR Clinical Trial

Public title

Phase I/II trial of neoadjuvant intravenous gemcitabine plus intra-arterial cisplatin in muscle-invasive bladder cancer.

Acronym

Phase I/II trial of neoadjuvant intravenous gemcitabine plus intra-arterial cisplatin in muscle-invasive bladder cancer.

Scientific Title

Phase I/II trial of neoadjuvant intravenous gemcitabine plus intra-arterial cisplatin in muscle-invasive bladder cancer.

Scientific Title:Acronym

Phase I/II trial of neoadjuvant intravenous gemcitabine plus intra-arterial cisplatin in muscle-invasive bladder cancer.

Region

Japan

Condition

bladder cancer

Classification by specialty

Urology

Classification by malignancy

Malignancy

Genomic information

NO

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

Primary outcomes

pathological complete response rate

Key secondary outcomes

clinical response rate
progression free survival
overall survival
bladder preservation rate
adverse drug reaction

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

Name of lead principal investigator

1st name
Middle name
Last name	Ryoji Kimata

Organization

Nippon Medical School Musashokosugi Hospital

Division name

Department of Urology

Zip code

Address

1-396 Kosugi-machi, Nakahara-ku, Kawasaki city, Kanagawa

TEL

044-733-5181

Email

s2027@nms.ac.jp

Name of contact person

1st name
Middle name
Last name	Hitomi Sakai

Organization

Nippon Medical School Musashokosugi Hospital

Division name

Department of Medical Oncology

Zip code

Address

1-396 Kosugi-machi, Nakahara-ku, Kawasaki city, Kanagawa

TEL

044-733-5181

Homepage URL

Email

hitomisakai@nms.ac.jp

Institute

Nippon Medical School Musashokosugi Hospital

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2014

Year

04

Month

04

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Terminated

Date of protocol fixation

2014

Year

02

Month

11

Day

Date of IRB

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

Other related information

Registered date

2014

Year

04

Month

04

Day

Last modified on

2019

Year

01

Month

09

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015913