UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034657 |
|---|---|
| Receipt number | R000039135 |
| Scientific Title | Amrubicin at a dose of 45mg/m2 with pegylated granulocyte-colony stimulating factor support in patients with previously treated small-cell lung cancer - A prospective observational study - |
| Date of disclosure of the study information | 2018/11/01 |
| Last modified on | 2023/05/01 09:38:50 |
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Basic information
Public title
Amrubicin at a dose of 45mg/m2 with pegylated granulocyte-colony stimulating factor support in patients with previously treated small-cell lung cancer - A prospective observational study -
Acronym
Amrubicin 45mg/m2 with pegylated granulocyte-colony stimulating factor support
Scientific Title
Amrubicin at a dose of 45mg/m2 with pegylated granulocyte-colony stimulating factor support in patients with previously treated small-cell lung cancer - A prospective observational study -
Scientific Title:Acronym
Amrubicin 45mg/m2 with pegylated granulocyte-colony stimulating factor support
Region
| Japan |
Condition
Condition
small-cell lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Evaluate the efficacy and safety of Amrubicin 45 mg/m2 therapy with PEG-G-CSF support for pre-treated advanced small cell lung cancer.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Overall Response Rate
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
1. Histologically confirmed diagnosis of primary small cell lung cancer (SCLC).
2. Provision of written informed consent prior to any study specific procedures.
3. Male or female, aged at least 20 years.
4. The Eastern Cooperative Oncology Group(ECOG) Performance Status of 0 to 2.
5. It is judged that the patient is possible to survive for 3 months or more from the date of registration.
6. Measurable disease in accordance with RECIST Version 1.1.
7. Main organs function is maintained.
8. The patient has been treated with chemotherapy for SCLC.
9. There is no history of administration of Amrubicin.
Key exclusion criteria
1.Transfusion and administration of hematopoietic factor preparations within 14 days before registration.
2.Serious renal dysfunction, or urine protein 2+ or higher in tests registered within 14 days.
3.Serious drug allergy.
4.Duplicate cancer of active.
5.Infections requiring systemic treatment.
6.Fever above 38 degrees Celsius.
7. Significant electrocardiogram abnormality or clinically problematic heart disease.
8. Severe lung disease.
9. Fresh bleeding from the gastrointestinal tract, intestinal palsy, intestinal obstruction or peptic ulcer.
10. Pleural effusion, ascites and pericardial effusion requiring removal of body cavity fluid by drain.
11. Defective thromboembolism.
12. Symptomatic brain metastasis.
13. Serious psychiatric disorders, central nervous disorders or cerebrovascular disorders.
14. Control poor hypertension or diabetes.
15. Severe bone marrow suppression.
16. Pregnant women, lactating women or women with a positive pregnancy test. A woman without intention to contraception. A woman wishing to become pregnant or breastfeeding. A man who is willing to conceive.
17. Cases the attending physician determines that inappropriate to participate in the test.
Target sample size
17
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akira Yamasaki |
Organization
Tottori University Hospital
Division name
Division of Medical Ontology and Molecular Respirology Tottori University Faculty of Medicine
Zip code
Address
36-1 Nishi-cho, Yonago, Tottori, Japan
TEL
0859-38-6537
yamasaki@med.tottori-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomohiro Sakamoto |
Organization
Tottori University Hospital
Division name
Division of Medical Ontology and Molecular Respirology Tottori University Faculty of Medicine
Zip code
Address
36-1 Nishi-cho, Yonago, Tottori, Japan
TEL
0859-38-6537
Homepage URL
t-sakamoto@med.tottori-u.ac.jp
Sponsor or person
Institute
Tottori University Hospital
Division of Medical Ontology and Molecular Respirology Tottori University Faculty of Medicine
Institute
Department
Personal name
Funding Source
Organization
Tottori University Hospital
Division of Medical Ontology and Molecular Respirology Tottori University 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
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
| 2018 | Year | 11 | Month | 01 | 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
Terminated
Date of protocol fixation
| 2018 | Year | 09 | Month | 27 | Day |
Date of IRB
| 2018 | Year | 10 | Month | 21 | Day |
Anticipated trial start date
| 2018 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
In order to investigate the safety and efficacy of Amrubicin 45 mg/m^2 therapy with PEG-G-CSF support on previously treated advanced small cell lung cancer, observe the cases prospectively.
Management information
Registered date
| 2018 | Year | 10 | Month | 26 | Day |
Last modified on
| 2023 | Year | 05 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039135
