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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000034657
Receipt No. 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 2018/10/26

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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
Email 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
Email t-sakamoto@med.tottori-u.ac.jp

Sponsor
Institute Tottori University Hospital
Division of Medical Ontology and Molecular Respirology Tottori University Faculty of Medicine
Institute
Department

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
Email

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 Preinitiation
Date of protocol fixation
2018 Year 09 Month 27 Day
Date of IRB
Anticipated trial start date
2018 Year 11 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 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
2018 Year 10 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039135

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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