UMIN-CTR Clinical Trial

Public title

An investigation of antitumor effectiveness using M-VAC/CaG prediction system in neoadjuvant chemotherapy for muscle invasive bladder cancer.

Acronym

An investigation of antitumor effectiveness using M-VAC/CaG prediction system in neoadjuvant chemotherapy for muscle invasive bladder cancer.

Scientific Title

An investigation of antitumor effectiveness using M-VAC/CaG prediction system in neoadjuvant chemotherapy for muscle invasive bladder cancer.

Scientific Title:Acronym

An investigation of antitumor effectiveness using M-VAC/CaG prediction system in neoadjuvant chemotherapy for muscle invasive bladder cancer.

Region

Japan

Condition

Muscle-invasive bladder cancer

Classification by specialty

Urology

Classification by malignancy

Malignancy

Genomic information

YES

Narrative objectives1

An investigation of the efficacy of neoadjuvant chemotherapy for muscle-invasive bladder cancer using prediction systems in comparison with historical controls.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Developmental phase

Phase II

Primary outcomes

The primary endpoints of this study are accuracy and efficacy of prediction systems, proportion of achieving significant tumor shrinking (>60%) by either or both of the two regimens with intention-to-treat compared with that of historical controls.

Key secondary outcomes

The secondary endpoint is the overall survival between the patients of this prospective study and the historical controls.

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Historical

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Based on the results of the prediction score and patient's wishes the patients were allocated into four treatments; neoadjuvant M-VAC, neoadjuvant CaG, operation or radiation therapy without neoadjuvant chemotherapy

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

Samples had been confirmed histologically as urothelial carcinoma of the bladder are selected for this study.
No node metastasis through computed tomography from their chest to pelvis and magnetic resonance imaging of their abdomen and pelvis at clinical stages T2aN0M0 to T4aN0M0 (Stage II-III) and were expected to undergo radical cystectomy without prior radiation therapy.
No serious abnormality in renal, hepatic or hematologic function and an Eastern Cooperative Oncology Group performance status (PS) judged to be <=2.

Key exclusion criteria

1) The case with serious complications
2) The case with active double cancer
3) The case with pregnancy, lactation or possibility of pregnancy
4) The case with drug allergy for G-CSF
5) The case with drug allergy for M-VAC or CaG
6) The case without the selection criteria

Target sample size

35

Name of lead principal investigator

1st name
Middle name
Last name	Wataru Obara

Organization

Iwate Medical University

Division name

Urology

Zip code

Address

19-1 Uchimaru, Morioka, Iwate

TEL

0196515111

Email

watao@iwate-med.ac.jp

Name of contact person

1st name
Middle name
Last name	Yoichiro Kato

Organization

Iwate Medical University

Division name

Urology

Zip code

Address

19-1 Uchimaru, Morioka, Iwate

TEL

0196515111

Homepage URL

Email

j2c789@bma.biglobe.ne.jp

Institute

Department of Urology, Iwate Medical University

Institute

Department

Personal name

Organization

Department of Urology, Iwate Medical University

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

2015

Year

11

Month

23

Day

URL releasing protocol

Publication of results

Published

URL related to results and publications

https://www.spandidos-publications.com/10.3892/ol.2018.9330

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

Completed

Date of protocol fixation

2011

Year

03

Month

11

Day

Date of IRB

Anticipated trial start date

2011

Year

03

Month

11

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2015

Year

11

Month

23

Day

Last modified on

2018

Year

09

Month

08

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022986