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

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

Status

Terminated

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00286169

Enrollment

130

Registered

2006-02-03

Start date

2006-04-30

Completion date

Unknown

Last updated

2022-04-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Small-cell Lung Cancer

Keywords

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

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.

Interventions

DRUGAmrubicin Hydrochloride

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

70 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Overall survival	—

Secondary

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

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026