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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001154
Receipt No. R000001400
Scientific Title A Feasibility Trial of Tri-modality Therapy for Resectable Malignant Pleural Mesothelioma
Date of disclosure of the study information 2008/05/12
Last modified on 2012/10/11

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Basic information
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
Condition Malignant pleural mesothelioma
Classification by specialty
Chest surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
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

Assessment
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

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
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

Eligibility
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

Research contact person
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

Public contact
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

Sponsor
Institute Hyogo College of Medicine
Institute
Department

Funding Source
Organization Japan Science and Technology AgencyMinistry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2008 Year 05 Month 12 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
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

Progress
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
Other related information

Management information
Registered date
2008 Year 05 Month 12 Day
Last modified on
2012 Year 10 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001400

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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