UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045496 |
|---|---|
| Receipt number | R000051943 |
| Scientific Title | A study on feasibility and safety of intensity-modulated radiotherapy after pleurectomy/decortication for malignant pleural mesothelioma |
| Date of disclosure of the study information | 2021/09/30 |
| Last modified on | 2023/09/23 09:19:56 |
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Basic information
Public title
A study on feasibility and safety of intensity-modulated radiotherapy after lung-sparing surgery for malignant pleural mesothelioma
Acronym
IMRT after lung-sparing surgery for malignant pleural mesothelioma
Scientific Title
A study on feasibility and safety of intensity-modulated radiotherapy after pleurectomy/decortication for malignant pleural mesothelioma
Scientific Title:Acronym
IMRT after P/D for malignant pleural mesothelioma
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 feasibility and safety of intensity-modulated radiotherapy after pleurectomy/decortication for malignant pleural mesothelioma
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Completion rate of the treatment
Key secondary outcomes
Acute toxicities, late toxicities, overall survival, local control, progression-free survival, and dose-volumetric factors
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-modulated radiotherapy
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
- Malignant pleural mesothelioma which is macroscopic-completely resected with pleurectomy/decortication
- Epithelioid or biphasic histology
- Pathological stage of IA to IIIA (= T1-3N0-1M0)
- No evidence of distant metastasis
- Performance status of 0-1
- Neo-adjuvant or adjuvant chemotherapy is completed
Key exclusion criteria
- Synchronous cancer or metachronous cancer with disease-free interval less than 5 years
- A history of thoracic radiotherapy
- Obvious pulmonary fibrosis and interstitial pneumonia
- Serious cardiac disease, serious arrhythmia, serious infectious disease, neuropsychiatric disease
- Diabetes mellitus difficult to control, or diseases requiring steroids
- Patients who have difficulty in understanding the consent document or in expressing their intention to receive treatment
- Other cases deemed inappropriate by the principal investigator/investigator
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | Noriko |
| Middle name | |
| Last name | Kishi |
Organization
Kyoto University Graduate School of Medicine
Division name
Radiation Oncology and Image-applied Therapy
Zip code
606-8507
Address
54 Shogoin Kawahara-cho, Sakyo, Kyoto
TEL
075-751-3762
kishin@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Noriko |
| Middle name | |
| Last name | Kishi |
Organization
Kyoto University Graduate School of Medicine
Division name
Radiation Oncology and Image-applied Therapy
Zip code
606-8507
Address
54 Shogoin Kawahara-cho, Sakyo, Kyoto
TEL
075-751-3762
Homepage URL
kishin@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto University Graduate School of Medicine and Faculty of Medicine, Ethics Committee
Address
Yoshida-Konoe-cho, Sakyo, Kyoto
Tel
075-753-4680
ethcom@kuhp.kyoto-u.ac.jp
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
京都大学医学部附属病院（京都府）
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 09 | Month | 30 | 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
Enrolling by invitation
Date of protocol fixation
| 2021 | Year | 09 | Month | 16 | Day |
Date of IRB
| 2021 | Year | 09 | Month | 21 | Day |
Anticipated trial start date
| 2021 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 09 | Month | 16 | Day |
Last modified on
| 2023 | Year | 09 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051943
