UMIN-CTR Clinical Trial

Public title

Organ-preserved tetra-modality therapy for patient having muscle invasive urothelial carcinoma 'OMC-regimen'

Acronym

OMCRT

Scientific Title

Organ-preserved tetra-modality therapy for patient having muscle invasive urothelial carcinoma 'OMC-regimen'

Scientific Title:Acronym

OMCRT

Region

Japan

Condition

Muscle invasive bladder carcinoma (MIBC) including regional lymph node metastasis

Classification by specialty

Hematology and clinical oncology	Urology	Radiology
Adult

Classification by malignancy

Malignancy

Genomic information

YES

Narrative objectives1

To determine efficacy and safety of organ preserved tetra-modality therapy based on Balloon-oculuted arterial infusion-BOAI consisted of TUR-BT, chemotherapy, and irridiation named OMC-regimen.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II,III

Primary outcomes

1. Disease-free surviva: The time to relapse is defined as the time from the date of randomization to the date of the first event. Time to relapse for patients without any event (local, regional, distance, or death) will be censored at the date of latest information.

2. CR inductivity rate assessed histologically applying TURBT three months after the treatment sequence as well as computed tomography to evaluate metastasis.

Key secondary outcomes

1. Overall survival:the time to death is defined as time from the randomization to the date of death from any cause, or to the date on which latest information is obtained.

2. •Acute and late toxicities: acute and late toxicities will be scored according to the NCI-CTC v4.0.

3. •Quality of life using questionnaires (i.e. IPSS, OABSS, IIEF5,etc)

Study type

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -but assessor(s) are blinded

Control

Active

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine	Device,equipment	Maneuver
Other

Interventions/Control_1

Tetra-modality therapy for MIBC

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

18

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

Muscle invasive urothelial cancer (front line or following the progression of a superficial tumor), pTis-pT4 stage without non regional lymphatic impairment (N3) and without detectable metastases (M0).

The proof of invasive tumor to the muscle should be brought by a transurethral resection under anaesthesia less than 8 weeks before or, in the absence, by superficial biopsies and formal imaging. Multiples biopsies in the bladder must also be performed.

Age ≥ 18 years

Life expectancy ≥ 6 months

Kanorfsky index ≥ 70 % (WHO 0, 1, 2)

Biological criteria: neutrophils ≥ 1500/mm3, Platelets ≥ 100 000/mm3, haemoglobin ≥ 10 g/dl, creatinine clearance > 60 ml/mn

Efficient contraception for premenopausal women, maintained during the whole treatment and up to two months after the completion of radiotherapy.

No radiotherapy or chemotherapy history except for in situ bladder lesions.

No contraindication to gemcitabine or cisplatin.

No contraindication to radiotherapy

Information letter and informed consent signed

Key exclusion criteria

Epidermoid carcinoma or adenocarcinoma

Distance metastases or extrapelvic node positivity

Severe digestive history (ulcerative colitis, complicated diverticulitis)

Pregnancy and breast feeding

Target sample size

500

Name of lead principal investigator

1st name
Middle name
Last name	Haruhito Azuma

Organization

Osaka medical college

Division name

Department of urology

Zip code

Address

2-7 Daigakumachi, Takatsuki city, Osaka, Japan

TEL

81-726-83-1221

Email

uro051@poh.osaka-med.ac.jp

Name of contact person

1st name
Middle name
Last name	Kazumasa Komura

Organization

Osaka medical college

Division name

Department of urology

Zip code

Address

2-7 Daigakumachi, Takatsuki city, Osaka, Japan

TEL

81-726-83-1221

Homepage URL

Email

uro051@poh.osaka-med.ac.jp

Institute

Osaka medical college, Department of urology

Institute

Department

Personal name

Organization

Osaka medical college, Department of urology

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

01

Month

26

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

Open public recruiting

Date of protocol fixation

2012

Year

01

Month

26

Day

Date of IRB

Anticipated trial start date

2012

Year

02

Month

01

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

01

Month

26

Day

Last modified on

2014

Year

02

Month

01

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015151