search
Back to results

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
Sumitomo Pharma Co., Ltd.
About
Eligibility
Locations
Outcomes
Full info

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

70 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
February 1, 2006
Last Updated
April 9, 2022
Sponsor
Sumitomo Pharma Co., Ltd.
search

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)

We'll reach out to this number within 24 hrs