UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009440 |
|---|---|
| Receipt number | R000011076 |
| Scientific Title | Phase II Study of Weekly Amrubicin in Patients with Refractory or Relapsed Small Cell Lung Cancer (CJLSG1103) |
| Date of disclosure of the study information | 2012/12/03 |
| Last modified on | 2019/09/20 10:02:53 |
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Basic information
Public title
Phase II Study of Weekly Amrubicin in Patients with Refractory or Relapsed Small Cell Lung Cancer (CJLSG1103)
Acronym
Phase II Study of Weekly Amrubicin in Patients with Refractory or Relapsed Small Cell Lung Cancer (CJLSG1103)
Scientific Title
Phase II Study of Weekly Amrubicin in Patients with Refractory or Relapsed Small Cell Lung Cancer (CJLSG1103)
Scientific Title:Acronym
Phase II Study of Weekly Amrubicin in Patients with Refractory or Relapsed Small Cell Lung Cancer (CJLSG1103)
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
The aim of the present study is to assess the efficacy and safety of weekly amurubicin in patients with refractory or relapsed 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: PFS
Overall survival: OS
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
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Patients receive amurubicin on days 1 and 8 every 3 weeks.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Histologically or cytologically proven small cell lung cancer
2. Refractory to or relapsed after first-line platinum-containing chemotherapy, and fit for systemic chemotherapy
3. No prior use of amrubicin
4. Patients aged 20 or over
5. ECOG Performance Status of 0 to 2
6. With measurable lesion (RECIST 1.1)
7. Adequate main organ functions
8. Expected life expectancy of 3 months or more from the start of the treatment
9. Written informed consent
Key exclusion criteria
1. Patients with contraindication for amrubicin
2. Patients with carcinomatous pleuritis, pericarditis, or peritonitis with the indication for local therapy
3. Patients during radiotherapy
4. Patients with symptomatic brain metastasis
5. Patients with SVC syndrome
6. Patients with cardiac dysfunction, myocardial infarction occurred within 6 months, uncontrolled angina pectoris, or uncontrolled cardiac failure
7. Patients with interstitial pneumonitis or pulmonary fibrosis on chest X-ray
8. Patients with uncontrolled diabetes mellitus
9. Patients who have been treated with limiting dose of anthracycline antitumor drug
10. Patients with active double cancer
11. Infected patients or possibly infected patients with a fever of 38 degrees Celsius or more
12. Pregnant or lactating woman
13. Patients whose participation in the trial is judged to be inappropriate by the attending doctor
Target sample size
35
Research contact person
Name of lead principal investigator
| 1st name | Hideo |
| Middle name | |
| Last name | Saka |
Organization
National Hospital Organization Nagoya Medical Center
Division name
Department of Respiratory Medicine
Zip code
460-0001
Address
4-1-1, Sannomaru, Naka-ku, Nagoya, Aichi, Japan
TEL
052-951-1111
saka@nagoya.hosp.go.jp
Public contact
Name of contact person
| 1st name | Hiroshige |
| Middle name | |
| Last name | Yoshioka |
Organization
Kurashiki Central Hospital
Division name
Department of Respiratory Medicine
Zip code
710-8602
Address
1-1-1, Miwa, Kurashiki, Japan
TEL
086-422-0210
Homepage URL
hgyoshioka@gmail.com
Sponsor or person
Institute
Central Japan Lung Study Group (CJLSG)
Institute
Department
Personal name
Funding Source
Organization
Central Japan Lung Study Group (CJLSG)
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
National Hospital Organization Review Board for Clinical Trials (Nagoya)
Address
4-1-1 Sannomaru, Naka-ku, Nagoya, Aichi, Japan
Tel
052-951-1111
saka@nagoya.hosp.go.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
国立病院機構名古屋医療センター(愛知県)、倉敷中央病院(岡山県)、中日本呼吸器臨床研究機構(CJLSG)参加施設
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 12 | Month | 03 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Twenty one patients at seven centers in Japan were enrolled from 2012 through 2015. A partial response (PR) was noted in one out of the first 18 patients. The study was terminated early according to the termination criteria in the protocol. In total, the response rate was 19% (no complete responses and four PRs) and the disease control rate was 81% (17/21). Median overall survival was 288 days (95% confidence interval(CI)=208-424 days), while median progression-free survival was 113 days (95% CI=45-202 days).
This study failed to demonstrate any efficacy of weekly amrubicin for refractory/relapsed small cell lung cancer.
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
Completed
Date of protocol fixation
| 2012 | Year | 10 | Month | 17 | Day |
Date of IRB
| 2012 | Year | 10 | Month | 29 | Day |
Anticipated trial start date
| 2012 | Year | 12 | Month | 03 | Day |
Last follow-up date
| 2017 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 11 | Month | 30 | Day |
Last modified on
| 2019 | Year | 09 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011076
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