UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038186 |
|---|---|
| Receipt number | 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 17:02:25 |
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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
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
hnomori@qk9.so-net.ne.jp
Sponsor or person
Institute
Kashiwa Kousei General Hospital,
Department of Thoracic Surgery
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043527
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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