UMIN-CTR Clinical Trial

Public title

Multiinstitutional study of boron neutron capture therapy for malignant pleural mesotelioma

Acronym

Boron neutron capture therapy for malignant pleural mesotelioma

Scientific Title

Multiinstitutional study of boron neutron capture therapy for malignant pleural mesotelioma

Scientific Title:Acronym

Boron neutron capture therapy for malignant pleural mesotelioma

Region

Japan

Condition

malignant pleural mesothelioma

Classification by specialty

Pneumology	Hematology and clinical oncology	Chest surgery
Radiology

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

Assessment of the safety and efficacy of boron neutron capture therapy for maliganat pleural mesothelioma resistant to standard treatment

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Adverse effects and their grade

Key secondary outcomes

Overall survival time, progression free survival, regression of tumor, grade of pain

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

Maneuver

Interventions/Control_1

At first the maliganat pleural mesothelioma patient resistant to standard treatment receives F-BPA PET. Base upon the tumor to blood ration of F-BPA radioactivity, only the patient with T/B ratio over 2.25 is enrolled into this study. BPA of 500mg/kg body weight is infused intravenously for 3 hours. Neutron is irradiated in last 1 hour during BPA infusion. The treatment is repeatted twice. Neutrons are delivered from either ventral or dorsal side of thorax at first treatment. And 3-4 weeks after first treatmentat second treatment, neutrons are given form opposite side. Thereafter, the patient is carefully watched on adverse effects and efficacy of the treatment.

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

75

years-old

>=

Gender

Male and Female

Key inclusion criteria

1)Histopatholigical confirmation as malignant pleural mesothelioma
2)Resistant to PEM or PEM+CDDP chemotherapy
3)The tumor is located only in one side of thorax
4)IC possible person of 20 to 75 years old
5)ECOG Performance Status (PS) is 0 or 1
6)Clinical test are within following values.
WBC more than 3,000 /micro-l
Hb more than 8.0 g/dl
Pt more than 100,000 /micro-l
AST (GOT) less than 100 IU/l
ALT (GPT) less than 100 IU/l
Serum Creatinine less than 1.5 mg/dl

Key exclusion criteria

The patient to whom one of following criterias apply.
1)Either one among following conditions
transdiaphrgm invasion to the abdomen
direct invasion to opposite thorax
invasuion to the mediastinum
invasuion to the spine
invasuion to the pericardium
2)Metastasis to the carina lymphnode
3)Distant metastasis
4)Previous radiotherapy to the thorax
5)Chemotherapy within 1 month at registration
6)Pregnant, possiblly pregnat or nursing woman
7)Phenylketonuria
8)Grade 3 or 4 in NYHA classification of cardiac performance
9)Doctors responsible for the study decide as wrong to the entry

Target sample size

20

Name of lead principal investigator

1st name
Middle name
Last name	Koji Ono

Organization

Kyoto University Research Reactor Institute

Division name

Particle Radiation Oncology Research Center

Zip code

Address

2-1010, Asashiro nishi, Kumatori-cho, Sennan-gun, Osaka 590-0494, Japan

TEL

+81-072-451-2475

Email

Name of contact person

1st name
Middle name
Last name	Koji Ono

Organization

Kyoto University Research Reactor Institute

Division name

Particle Radiation Oncology Research Center

Zip code

Address

2-1010, Asashiro nishi, Kumatori-cho, Sennan-gun, Osaka 590-0494, Japan

TEL

+81-072-451-2475

Homepage URL

Email

onokoji@rri.kyoto-u.ac.jp

Institute

Particle Radiation Oncology Research Center,Kyoto University Research Reactor Institute

Institute

Department

Personal name

Organization

Ministry of Health, Labour and Welfare

Organization

Division

Category of Funding Organization

Nationality of Funding Organization

Co-sponsor

Translational Research Informatics (TRI) center

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

京都大学原子炉実験所（大阪府）
川崎医科大学病院（岡山県）
兵庫医科大学病院（兵庫県）
兵庫県立尼崎病院（兵庫県）
大阪大学病院（大阪府）
近畿大学病院（大阪府）

Date of disclosure of the study information

2011

Year

05

Month

16

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

2011

Year

04

Month

12

Day

Date of IRB

Anticipated trial start date

2011

Year

06

Month

01

Day

Last follow-up date

2013

Year

05

Month

01

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2011

Year

04

Month

21

Day

Last modified on

2011

Year

11

Month

15

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006497