Amrubicin Study for Elderly Patients With Extensive-disease Small-cell Lung Cancer (ED-SCLC)
Primary Purpose
Small-cell Lung Cancer
Status
Terminated
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
Amrubicin Hydrochloride
Sponsored by
About this trial
This is an interventional treatment trial for Small-cell Lung Cancer focused on measuring Extensive-disease small-cell lung cancer (ED-SCLC)
Eligibility Criteria
Inclusion Criteria: Extensive-disease small-cell lung cancer Aged 70 years or older Performance status of 0-2 No prior chemotherapy Exclusion Criteria: Prior therapy for primary lesion Pneumonitis and/or pulmonary fibrosis Active concomitant malignancy
Sites / Locations
- Chubu Region Site
- Chugoku Region Site
- Hokkaido Region Site
- Kanto Region Site
- Kinki Region Site
- Kyushu Region Site
- Shikoku Region Site
- Tohoku Region Site
Outcomes
Primary Outcome Measures
Overall survival
Secondary Outcome Measures
Time to progression
Objective tumor response
Quality of Life (QOL: EuroQOL, FACT-L-LCS)
Frequency and severity of adverse events
Full Information
NCT ID
NCT00286169
First Posted
February 1, 2006
Last Updated
April 9, 2022
Sponsor
Sumitomo Pharma Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT00286169
Brief Title
Amrubicin Study for Elderly Patients With Extensive-disease Small-cell Lung Cancer (ED-SCLC)
Official Title
Randomized Phase III Trial of Amrubicin Versus Carboplatin Plus Etoposide in Elderly Patients With Extensive-disease Small-cell Lung Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Terminated
Study Start Date
April 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Sumitomo Pharma Co., Ltd.
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to compare the efficacy and toxicity of amrubicin with carboplatin plus etoposide in elderly patients with extensive-disease small-cell lung cancer.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Small-cell Lung Cancer
Keywords
Extensive-disease small-cell lung cancer (ED-SCLC)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
130 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Amrubicin Hydrochloride
Primary Outcome Measure Information:
Title
Overall survival
Secondary Outcome Measure Information:
Title
Time to progression
Title
Objective tumor response
Title
Quality of Life (QOL: EuroQOL, FACT-L-LCS)
Title
Frequency and severity of adverse events
10. Eligibility
Sex
All
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Extensive-disease small-cell lung cancer
Aged 70 years or older
Performance status of 0-2
No prior chemotherapy
Exclusion Criteria:
Prior therapy for primary lesion
Pneumonitis and/or pulmonary fibrosis
Active concomitant malignancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Drug Development Division
Organizational Affiliation
Sumitomo Pharma Co., Ltd.
Official's Role
Study Director
Facility Information:
Facility Name
Chubu Region Site
City
Chubu
Country
Japan
Facility Name
Chugoku Region Site
City
Chugoku
Country
Japan
Facility Name
Hokkaido Region Site
City
Hokkaido
Country
Japan
Facility Name
Kanto Region Site
City
Kanto
Country
Japan
Facility Name
Kinki Region Site
City
Kinki
Country
Japan
Facility Name
Kyushu Region Site
City
Kyushu
Country
Japan
Facility Name
Shikoku Region Site
City
Shikoku
Country
Japan
Facility Name
Tohoku Region Site
City
Tohoku
Country
Japan
12. IPD Sharing Statement
Learn more about this trial
Amrubicin Study for Elderly Patients With Extensive-disease Small-cell Lung Cancer (ED-SCLC)
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