UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016056 |
|---|---|
| Receipt number | R000018356 |
| Scientific Title | PhaseII study of pleurectomy/decortication and intraoperative intrapleural hyperthermic cisplatin perfusion |
| Date of disclosure of the study information | 2014/12/26 |
| Last modified on | 2014/12/25 20:38:04 |
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Basic information
Public title
PhaseII study of pleurectomy/decortication and intraoperative intrapleural hyperthermic cisplatin perfusion
Acronym
PhaseII study of pleurectomy/decortication and intraoperative intrapleural hyperthermic cisplatin perfusion
Scientific Title
PhaseII study of pleurectomy/decortication and intraoperative intrapleural hyperthermic cisplatin perfusion
Scientific Title:Acronym
PhaseII study of pleurectomy/decortication and intraoperative intrapleural hyperthermic cisplatin perfusion
Region
| Japan |
Condition
Condition
malignant pleural mesothelioma
Classification by specialty
| Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Examine surgical outcomes and safety of pleurectomy/decortication and intraoperative intrapleural hyperthermic cisplatin perfusion
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Phase II
Assessment
Primary outcomes
disease free survival
Key secondary outcomes
overall survival
side effect
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 | Maneuver |
Interventions/Control_1
Pleurectomy/Decortication and Intraoperative Intrapleural Hyperthermic Cisplatin Perfusion
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
histologically proven MPM, surgically resectable (T1-3N0-2), without distant metastasis, and patients who are not candidates for EPP as a result of insufficient cardiopulmonary reserve, advanced age, or poor performance status (PS).
Key exclusion criteria
past history of malignant mesothelioma
severe complication of heart, liver or renal function
interstitial pneumonia
possibility of pregnancy,patient with pregnancy
past history of severe drug allergy
concomitant cancer of other organs
Target sample size
35
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kenichi Okubo |
Organization
Tokyo Medical and Dental University
Division name
Thoracic Surgery
Zip code
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo
TEL
03-3813-6111
okubo.thsr@tmd.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hironori Ishibashi |
Organization
Tokyo Medical and Dental University
Division name
Thoracic Surgery
Zip code
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo
TEL
03-3813-6111
Homepage URL
hishiba.thsr@tmd.ac.jp
Sponsor or person
Institute
Department of Thoracic Surgery, Tokyo Medical and Dental University
Institute
Department
Personal name
Funding Source
Organization
Department of Thoracic Surgery,Tokyo Medical and Dental University
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
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
| 2014 | Year | 12 | Month | 26 | 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
| 2010 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 10 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 12 | Month | 25 | Day |
Last modified on
| 2014 | Year | 12 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018356
