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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000030162
Receipt No. R000034448
Scientific Title Investigation of cancer control effect by intrathoracic pleural hyperthermo-perfusion chemotherapy using cisplatin for positive thoracic lavage cytology diagnosis after pulmonary carcinoma radical lobectomy or pleural dissemination
Date of disclosure of the study information 2017/12/15
Last modified on 2020/12/09

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Basic information
Public title Investigation of cancer control effect by intrathoracic pleural hyperthermo-perfusion chemotherapy using cisplatin for positive thoracic lavage cytology diagnosis after pulmonary carcinoma radical lobectomy or pleural dissemination
Acronym The effect of hyperthermic chemotherapy on lung cancer intrathoracic lesion
Scientific Title Investigation of cancer control effect by intrathoracic pleural hyperthermo-perfusion chemotherapy using cisplatin for positive thoracic lavage cytology diagnosis after pulmonary carcinoma radical lobectomy or pleural dissemination
Scientific Title:Acronym The effect of hyperthermic chemotherapy on lung cancer intrathoracic lesion
Region
Japan

Condition
Condition lung cancer
Classification by specialty
Chest surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 investigation about Efficacy of intrathoracic thermo-perfusion chemotherapy
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes long term survival
Key secondary outcomes

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
Interventions/Control_1 intrathoracic pleural hyperthermo-chemotherapy
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
80 years-old >=
Gender Male and Female
Key inclusion criteria positive intraoperative thoracic lavage cytology diagnosis after pulmonary carcinoma radical lobectomy or pleural dissemination
Key exclusion criteria none
Target sample size 30

Research contact person
Name of lead principal investigator
1st name AKITOSHI
Middle name
Last name OKADA
Organization university of Fukui, faculty of medicine
Division name thoracic surgery
Zip code 910-1193
Address 23-3 Shimoaituki Matsuoka Eiheiji-town Yoshidagun Fukui
TEL 0776-61-3111
Email lebleu@u-fukui.ac.jp

Public contact
Name of contact person
1st name AKITOSHI
Middle name
Last name OKADA
Organization university of Fukui, faculty of medicine
Division name thoracic surgery
Zip code 910-1193
Address 23-3 Shimoaituki Matsuoka Eiheiji-town Yoshidagun Fukui
TEL 0776-61-3111
Homepage URL
Email lebleu@u-fukui.ac.jp

Sponsor
Institute university of Fukui, faculty of medicine
Institute
Department

Funding Source
Organization university of Fukui, faculty of medicine
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 UNIVERSITY of FUKUI
Address 23-3 Shimoaituki Matsuoka Eiheiji-town Yoshidagun Fukui
Tel 0776-61-3111
Email chiken@ml.u-fukui.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 福井大学医学部附属病院

Other administrative information
Date of disclosure of the study information
2017 Year 12 Month 15 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
2013 Year 07 Month 05 Day
Date of IRB
2013 Year 07 Month 05 Day
Anticipated trial start date
2013 Year 07 Month 05 Day
Last follow-up date
2033 Year 07 Month 05 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 11 Month 29 Day
Last modified on
2020 Year 12 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034448

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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