UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000009548 |
|---|---|
| Receipt number | R000011202 |
| Scientific Title | Phase II Study of First-line Amrubicin in Elderly Patients with Extensive Disease Small-Cell Lung Cancer (CJLSG1104) |
| Date of disclosure of the study information | 2012/12/17 |
| Last modified on | 2015/12/14 13:24:15 |
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Basic information
Public title
Phase II Study of First-line Amrubicin in Elderly Patients with Extensive Disease Small-Cell Lung Cancer (CJLSG1104)
Acronym
Phase II Study of First-line Amrubicin in Elderly Patients with Extensive Disease Small-Cell Lung Cancer (CJLSG1104)
Scientific Title
Phase II Study of First-line Amrubicin in Elderly Patients with Extensive Disease Small-Cell Lung Cancer (CJLSG1104)
Scientific Title:Acronym
Phase II Study of First-line Amrubicin in Elderly Patients with Extensive Disease Small-Cell Lung Cancer (CJLSG1104)
Region
| Japan |
Condition
Condition
Small-cell lung cancer
Classification by specialty
| Pneumology | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of amrubicin monotherapy in elderly patients with previously untreated extensive disease small-cell lung cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Response rate
Key secondary outcomes
Progression free survival
Overall survival
Safety (incidence of adverse events)
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
Patients are treated with amrubicin 35 mg/m2 days 1-3 every 3 weeks. G-CSF are given for at least 4 days from day 8.
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
| 75 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Histologically or cytologically confirmed small-cell lung cancer
2.No indication of curative radiotherapy
3.Age 75 years or older
4.ECOG performance status of 0 to 2
5.With measurable lesion(s) according to RECIST 1.1
6.No previous chemotherapy or radiotherapy. Patients who have measurable lesion(s) after palliative radiotherapy to metastasis(es) or surgery are eligible if these treatments are finished at least 14 days ago before enrollment.
7.Adequate organ functions
8.Expected life expectancy of 3 months or more
9.Written informed consent
Key exclusion criteria
Patients with any of the following criteria are ineligible.
1.Contraindication for amrubicin
2.Massive pleural or pericardial or ascites that requires drainage
3.Under radiotherapy
4.Symptomatic brain metastasis(es)
5.Superior vena cava symdrome
6.Cardiac dysfunction or myocardial infarction occurred within 6 months or uncontrolled angina pectoris or uncontrolled heart failure
7.Interstitial pneumonitis or pulmonary fibrosis on chest X-ray
8.Uncontrolled diabetes mellitus
9.Other concurrent malignancy
10.Active infection or fever of 38 C or higher
11.History of serious drug allergy
12.Pregnancy or lactation
13.Other concomitant serious medical conditions
Target sample size
29
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroshi Saito |
Organization
Aichi Cancer Center Aichi Hospital
Division name
Department of Respiratory Medicine
Zip code
Address
Kuriyado 18, Kake-machi, Okazaki, Aichi 444-0011
TEL
0564-21-6251
hsaito@acc-aichi.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | HIroshi Saito |
Organization
Aichi Cancer Center Aichi Hospital
Division name
Department of Respiratory Medicine
Zip code
Address
Kuriyado 18, Kake-machi, Okazaki, Aichi 444-0011
TEL
0564-21-6251
Homepage URL
hsaito@acc-aichi.com
Sponsor or person
Institute
Central Japan Lung Study Group
Institute
Department
Personal name
Funding Source
Organization
Central Japan Lung Study Group
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
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
愛知県がんセンター愛知病院 （愛知県）、トヨタ記念病院（愛知県）、大垣市民病院（岐阜県）、名古屋第一赤十字病院（愛知県）、名古屋医療センター（愛知県）、藤田保健衛生大学病院（愛知県）、小牧市民病院（愛知県），公立陶生病院（愛知県）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 12 | Month | 17 | 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
| 2012 | Year | 11 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 01 | Month | 07 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 12 | Month | 14 | Day |
Last modified on
| 2015 | Year | 12 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000011202
