Amrubicin Study for Elderly Patients With Extensive-disease Small-cell Lung Cancer (ED-SCLC)

April 9, 2022 updated by: Sumitomo Pharma Co., Ltd.

Randomized Phase III Trial of Amrubicin Versus Carboplatin Plus Etoposide in Elderly Patients With Extensive-disease Small-cell Lung Cancer

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.

Study Overview

Status

Terminated

Conditions

Small-cell Lung Cancer

Intervention / Treatment

Drug: Amrubicin Hydrochloride

Study Type

Interventional

Enrollment (Anticipated)

130

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Japan
- - Chubu, Japan
    - Chubu Region Site
  - Chugoku, Japan
    - Chugoku Region Site
  - Hokkaido, Japan
    - Hokkaido Region Site
  - Kanto, Japan
    - Kanto Region Site
  - Kinki, Japan
    - Kinki Region Site
  - Kyushu, Japan
    - Kyushu Region Site
  - Shikoku, Japan
    - Shikoku Region Site
  - Tohoku, Japan
    - Tohoku Region Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

70 years and older (Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Overall survival

Secondary Outcome Measures

Outcome Measure
Time to progression
Objective tumor response
Frequency and severity of adverse events
Quality of Life (QOL: EuroQOL, FACT-L-LCS)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sumitomo Pharma Co., Ltd.

Investigators

Study Director: Drug Development Division, Sumitomo Pharma Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2006

Study Registration Dates

First Submitted

February 1, 2006

First Submitted That Met QC Criteria

February 1, 2006

First Posted (Estimate)

February 3, 2006

Study Record Updates

Last Update Posted (Actual)

April 12, 2022

Last Update Submitted That Met QC Criteria

April 9, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Extensive-disease small-cell lung cancer (ED-SCLC)

Additional Relevant MeSH Terms

Other Study ID Numbers

D0702002
JapicCTI-060203

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.