NCT00286169

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
130

participants targeted

Target at P25-P50 for phase_3

Geographic Reach
1 country

8 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 1, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 3, 2006

Completed
2 months until next milestone

Study Start

First participant enrolled

April 1, 2006

Completed
Last Updated

April 12, 2022

Status Verified

April 1, 2022

First QC Date

February 1, 2006

Last Update Submit

April 9, 2022

Conditions

Small-cell Lung Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

  • Overall survival

Secondary Outcomes (4)

  • Time to progression

  • Objective tumor response

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

  • Frequency and severity of adverse events

Interventions

Amrubicin HydrochlorideDRUG

Eligibility Criteria

Age70 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Extensive-disease small-cell lung cancer
  • Aged 70 years or older
  • Performance status of 0-2
  • No prior chemotherapy

You may not qualify if:

  • Prior therapy for primary lesion
  • Pneumonitis and/or pulmonary fibrosis
  • Active concomitant malignancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Chugoku Region Site

Chugoku, Japan

Location

Chubu Region Site

Chūbu, Japan

Location

Hokkaido Region Site

Hokkaido, Japan

Location

Kanto Region Site

Kanto, Japan

Location

Kinki Region Site

Kinki, Japan

Location

Kyushu Region Site

Kyushu, Japan

Location

Shikoku Region Site

Shikoku, Japan

Location

Tohoku Region Site

Tōhoku, Japan

Location

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Interventions

amrubicin

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Drug Development Division

    Sumitomo Pharma Co., Ltd.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

February 1, 2006

First Posted

February 3, 2006

Study Start

April 1, 2006

Last Updated

April 12, 2022

Record last verified: 2022-04

Locations

JP(8)