UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase I/II study of intensity-modulated radiation therapy as trimodality therapy for malignant pleural mesothelioma.
Title of the study (Brief title)	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	Masahiro Hiraoka
Organization	Kyoto University Hospital
Division name	Department of Radiation Oncology and Image-Applied Therapy
Address	54 Shogoin Kawaharacho Sakyo-ku, Kyoto, Japan
TEL
Email

Public contact
Name of contact person
Organization	Kyoto University Hospital
Division name	Department of Radiation Oncology and Image-Applied Therapy
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

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

Progress
Recruitment status	Completed
Date of protocol fixation	2009 Year 06 Month 18 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
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