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

NCT ID: NCT00286169

Last Updated: 2022-04-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Small-cell Lung Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Amrubicin Hydrochloride

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sumitomo Pharma Co., Ltd.

INDUSTRY

Sponsor Role lead

Principal Investigators

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Drug Development Division

Role: STUDY_DIRECTOR

Sumitomo Pharma Co., Ltd.

Locations

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Chugoku Region Site

Chugoku, , Japan

Site Status

Chubu Region Site

Chūbu, , Japan

Site Status

Hokkaido Region Site

Hokkaido, , Japan

Site Status

Kanto Region Site

Kanto, , Japan

Site Status

Kinki Region Site

Kinki, , Japan

Site Status

Kyushu Region Site

Kyushu, , Japan

Site Status

Shikoku Region Site

Shikoku, , Japan

Site Status

Tohoku Region Site

Tōhoku, , Japan

Site Status

Countries

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Japan

Other Identifiers

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JapicCTI-060203

Identifier Type: -

Identifier Source: secondary_id

D0702002

Identifier Type: -

Identifier Source: org_study_id

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