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

Phase 3TerminatedNCT00286169

Sumitomo Pharma Co., Ltd.130 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

130

Conditions

Small-cell Lung Cancer

Interventions

Amrubicin HydrochlorideDRUG

Eligibility

Sex: ALLMin age: 70 Years

Medical Language ↔ Plain English

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

Locations (8)

Chugoku Region Site

Chugoku, Japan

Chubu Region Site

Chūbu, Japan

Hokkaido Region Site

Hokkaido, Japan

Kanto Region Site

Kanto, Japan

Outcomes

Primary Outcomes

Overall survival

Secondary Outcomes

Time to progression

Objective tumor response

Quality of Life (QOL: EuroQOL, FACT-L-LCS)

Frequency and severity of adverse events

Data from ClinicalTrials.gov

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