UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002217 |
|---|---|
| Receipt number | 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 18:22:49 |
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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
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
Sponsor or person
Institute
Department of Radiation Oncology and Image-Applied Therapy, Kyoto University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002722
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
