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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000038186
Receipt No. R000043527
Scientific Title Study of trans arterial chemo-embolization for primary or metastatic lung cancer
Date of disclosure of the study information 2019/10/04
Last modified on 2019/10/02

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Basic information
Public title Study of trans arterial chemo-embolization for primary or metastatic lung cancer
Acronym c
Scientific Title Study of trans arterial chemo-embolization for primary or metastatic lung cancer
Scientific Title:Acronym Trans arterial chemo-embolization for lung cancer
Region
Japan

Condition
Condition Stage III/IV lung cancer or metastatic lung cancer, which are unresectable and refractory to standard chemotherapy
Classification by specialty
Hematology and clinical oncology Chest surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 For non-resectable stage III/IV lung cancer or metastatic lung cancer, which are located at mediastinum or lung hilum and refractory to standard chemotherapy, or those tumors in elderly patients, trans arterial cheemo-embolization via bronchial artery is conducted, of which efficacy and prognosis are investigated.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase III

Assessment
Primary outcomes For non-resectable stage III/IV lung cancer or metastatic lung cancer, which are located at mediastinum or lung hilum and refractory to standard chemotherapy, or those tumors in elderly patients, trans arterial cheemo-embolization via bronchial artery is conducted each 3 weeks with 3 courses at minimum, of which efficacy and prognosis are investigated.
Key secondary outcomes Accidental embolization at the non-target organs is investigated.

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 Trans arterial chemo-embolization is repeated evcery 3 weeks in principle, and is conducted 3 times at minimum.
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
10 years-old <=
Age-upper limit
100 years-old >=
Gender Male and Female
Key inclusion criteria 1. Mediasitnal and/or hilar tumors which are unresectablea and refbractory to standard chemotherapy.
2. Standard chemotherapy is not available because of elderly and complications.
3. Even having multiple metastatic lesions, long-term survival could be expected if the mediastinal or hilar tumors are shrunk.
4. Patients who agree for the risk and long-teerm forecast.
Key exclusion criteria Patients with anaphylaxis for contrast medium.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Hirooaki
Middle name
Last name Nomori
Organization Kashiwa Kousei General Hospital
Division name Department of Thoracic Surgery
Zip code 277-851
Address 617 Shikoda, Kashiwa City
TEL 0471-45-1111
Email hnomori@qk9.so-net.ne.jp

Public contact
Name of contact person
1st name Hiroaki
Middle name
Last name Nomori
Organization Kashiwa Kousei General Hospital
Division name Department of Thoracic Surgery
Zip code 277-851
Address 617 Shikoda, Kashiwa City
TEL 0471-45-1111
Homepage URL
Email hnomori@qk9.so-net.ne.jp

Sponsor
Institute Kashiwa Kousei General Hospital,
Department of Thoracic Surgery
Institute
Department

Funding Source
Organization Kashiwa Kousei General Hospital
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 Kashiwa Kousei General Hospital
Address 617 Shikoda, Kashiwa City,Chiba
Tel 0471-45-1111
Email hnomori@qk9.so-net.ne.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

Other administrative information
Date of disclosure of the study information
2019 Year 10 Month 04 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 Open public recruiting
Date of protocol fixation
2019 Year 09 Month 30 Day
Date of IRB
2019 Year 09 Month 30 Day
Anticipated trial start date
2019 Year 09 Month 30 Day
Last follow-up date
2029 Year 10 Month 01 Day
Date of closure to data entry
2029 Year 10 Month 01 Day
Date trial data considered complete
2029 Year 10 Month 01 Day
Date analysis concluded
2029 Year 10 Month 01 Day

Other
Other related information

Management information
Registered date
2019 Year 10 Month 02 Day
Last modified on
2019 Year 10 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043527

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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