UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002217
Receipt No. R000002722
Scientific Title Phase I/II study of intensity-modulated radiation therapy as trimodality therapy for malignant pleural mesothelioma.
Date of disclosure of the study information 2009/07/16
Last modified on 2017/02/01

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Phase I/II study of intensity-modulated radiation therapy as trimodality therapy for malignant pleural mesothelioma.
Acronym Phase I/II study/IMRT/trimodality therapy for MPM
Scientific Title Phase I/II study of intensity-modulated radiation therapy as trimodality therapy for malignant pleural mesothelioma.
Scientific Title:Acronym Phase I/II study/IMRT/trimodality therapy for MPM
Region
Japan

Condition
Condition Malignant Pleural Mesothelioma
Classification by specialty
Pneumology Chest surgery Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the safety and efficacy of intensity-modulated radiation therapy as adjuvant therapy after extrapleural pneumonectomy and chemotherapy for malignant pleural mesothelioma.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase I,II

Assessment
Primary outcomes Phase I: Adverse events within 180 days after IMRT.
Phase II: Relapse-free survival
Key secondary outcomes treatment(radiation therapy) completion rate, pattern of recurrence,
overall survival

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
Maneuver
Interventions/Control_1 Intensity-modurated radiotherapy(IMRT), using 6-10MV X-ray, daily 1.8Gy, 5 days/week until 50.4Gy, but for margin-positive lesions simultaneously boosted to 59.4Gy, after extrapleural pneumonectomy and chemotherapy w/CDDP and pemetrexed.
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

Not applicable
Age-upper limit
75 years-old >
Gender Male and Female
Key inclusion criteria 1.Histologically confirmed malignant pleural mesothelioma, any subtypes.
2.Clinical stage I-III, completely resected
3.Several courses of chemotherapy with CDDP and pemetrexed are previously performed.
4.Age <75
5.ECOG PS 0-1
6.Patients with normal contralateral renal function.
7.Patients with no other serious organ dysfunction
8.Patients must sign a study-specific consent form.

Key exclusion criteria 1.Patients with any previous thoracic surgery not intend to complete resection or chemotherapy except for CDDP/pemetrexed.
2.Patients with no adequate reconstoration of diaphragma.
3.Active another neoplasm or previous (wihin 5 years) malignansies
4.Previous radiotherapy to the chest
5.Serious heart disease, arrhythmia, hypofunction of residual lung, uncontrolled infection, pyschological difficulty
6.Uncontrolled diabetes, any complications need steroids therapies.
7.Not suitable for participating in the study for any reasons
Target sample size 13

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masahiro Hiraoka
Organization Kyoto University Hospital
Division name Department of Radiation Oncology and Image-Applied Therapy
Zip code
Address 54 Shogoin Kawaharacho Sakyo-ku, Kyoto, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Kyoto University Hospital
Division name Department of Radiation Oncology and Image-Applied Therapy
Zip code
Address 54 Shogoin Kawaharacho Sakyo-ku, Kyoto, Japan
TEL
Homepage URL
Email

Sponsor
Institute Department of Radiation Oncology and Image-Applied Therapy, Kyoto University Hospital
Institute
Department

Funding Source
Organization applying
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor None
Name of secondary funder(s) None

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
2009 Year 07 Month 16 Day

Related information
URL releasing protocol
Publication of results Published

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
2009 Year 06 Month 18 Day
Date of IRB
Anticipated trial start date
2009 Year 08 Month 01 Day
Last follow-up date
2016 Year 07 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
2009 Year 07 Month 16 Day
Last modified on
2017 Year 02 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002722

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.