UMIN-CTR Clinical Trial

Public title

A Feasibility Trial of Tri-modality Therapy for Resectable Malignant Pleural Mesothelioma

Acronym

A Feasibility Trial of Tri-modality Therapy for Resectable Malignant Pleural Mesothelioma

Scientific Title

A Feasibility Trial of Tri-modality Therapy for Resectable Malignant Pleural Mesothelioma

Scientific Title:Acronym

A Feasibility Trial of Tri-modality Therapy for Resectable Malignant Pleural Mesothelioma

Region

Japan

Condition

Malignant pleural mesothelioma

Classification by specialty

Chest surgery

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To assess feasibility (compliance and safety) of trimodality therapy consisting induction chemotherapy with cisplatin and pemetrexed, extrapleural pneumonectomy, and adjuvant hemithoracic radiotherapy

Basic objectives2

Safety

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Complete resection rate with extrapleural pneumonectomy
Mortality rate

Key secondary outcomes

Completion rate of trimodality therapy
Disease-free survival (at 2 years)
Overall survival (at 2 years)
Response rate of induction chemotherapy
Morbidity rate

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	Device,equipment	Maneuver

Interventions/Control_1

21-Day period as one course.
Cisplatin 60mg/m2 and pemetrexed 500mg/m2 on Day1.
Repeat for 3 courses
Within 6 weeks after the last day of the chemotherapy, it operates extrapleural pneumonectomy.
Within 12weeks after the extrapleural pneumonectomy, it starts radiation. It's hemithorax irradiation.
Total 30 times, five times a week, 1.8Gy once a day.
Total 54Gy.

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. Pathologically proved malignant pleural mesothelioma
2. Completely resectable disease
3. T0-3, N0-2, M0
4. Measurable disease not mandatory
5. No prior therapy for mesothelioma
6. Age : >=20 and <75
7. Performance status of 0-1 (ECOG)
8. Predicted forced expiratory volume at 1 second after extrapleural pneumonectomy >=1L
9. Adequate major organ function as follows:1) Hb >=9.0g/dl2) Neutrohil count >=2,000/mm33) Platelet count >=100,000/mm34) Serum albumin >=3.0g/dl5) AST and ALT <=2.5times of upper limit6) Total bilirubin <=1.5times of upper limit7) Serum creatinine <1.2mg/dl8) SpO2(or SaO2) at FiO20.21 >=95%9) No adnormal finding on ECG10) Creratinine clearance >=60mL/min
10. Patients with an estimated life expectancy of more than 12 weeks
11. Written informed consent

Key exclusion criteria

1. Serious or uncontrolled complication
2. Active infection
3. Active concomitant malignancy
4. Symptomatic brain metastasis
5. With prior unapproved drugs or investigational new drugs
6. With a history of sensitivity to platinum agent, folic acid or vitamin B12
7. Women with confirmed, lactating or suspected pregnancy. Patients who won't avoid pregnancy.
8. Peripheral neuropathy >= grade 2
9. Interstitial pneumonia or fibroid lung
10. Medically endorsed anticonception can't be assured till 90 days after the final administration
11. Inappropriate patients for entry on this trial in the judgment of the investigator.

Target sample size

40

Name of lead principal investigator

1st name
Middle name
Last name	Takashi Nakano

Organization

Hyogo College of Medicine

Division name

Division of Respiratory Medicine, Dept. of Internal Medicine

Zip code

Address

1-1 Mukogawa-cho Nishinomiya City Hyogo

TEL

Email

Name of contact person

1st name
Middle name
Last name

Organization

Japan Mesothelioma Research Center (JMRC)

Division name

Japan Mesothelioma Research Center (JMRC)

Zip code

Address

TEL

0798-45-6088

Homepage URL

http://www.hyo-med.ac.jp/department/jmrc/index.html

Email

choseihi@hyo-med.ac.jp

Institute

Hyogo College of Medicine

Institute

Department

Personal name

Organization

Japan Science and Technology AgencyMinistry of Education, Culture, Sports, Science and Technology

Organization

Division

Category of Funding Organization

Nationality of Funding Organization

Japan

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

2008

Year

05

Month

12

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

Completed

Date of protocol fixation

2008

Year

04

Month

02

Day

Date of IRB

Anticipated trial start date

2008

Year

05

Month

01

Day

Last follow-up date

2011

Year

04

Month

01

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2008

Year

05

Month

12

Day

Last modified on

2012

Year

10

Month

11

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001400