NCT00120679

Brief Summary

The purpose of this study is to validate a Patient Satisfaction Questionnaire for Anemia Treatment (PSQ-AT) in non small cell lung cancer patients treated with darbepoetin alfa or recombinant human erythropoietin (rHuEPO) for anemia due to chemotherapy.

Trial Health

100
On Track

Trial Health Score

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

Timeline
Completed

Started Oct 2002

Shorter than P25 for phase_2 nonsmall-cell-lung-cancer

Status
completed

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

Study Start

First participant enrolled

October 1, 2002

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2003

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

June 30, 2005

Completed
19 days until next milestone

First Posted

Study publicly available on registry

July 19, 2005

Completed
Last Updated

December 24, 2007

Status Verified

December 1, 2007

First QC Date

June 30, 2005

Last Update Submit

December 20, 2007

Conditions

Non-Small Cell Lung CancerAnemia

Keywords

non-small cell lung cancerdarbepoetin alfaAmgen

Outcome Measures

Primary Outcomes (1)

  • Anemia correction

Secondary Outcomes (2)

  • Patient preference

  • Activities of daily living

Interventions

darbepoetin alfaDRUG
recombinant human erythropoietin (rHuEPO)DRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Schwartzberg LS, Yee LK, Senecal FM, Charu V, Tomita D, Wallace J, Rossi G. A randomized comparison of every-2-week darbepoetin alfa and weekly epoetin alfa for the treatment of chemotherapy-induced anemia in patients with breast, lung, or gynecologic cancer. Oncologist. 2004;9(6):696-707. doi: 10.1634/theoncologist.9-6-696.

    PMID: 15561813BACKGROUND

Related Links

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell LungAnemia

Interventions

Darbepoetin alfa

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesHematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

ErythropoietinColony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesProteinsAmino Acids, Peptides, and Proteins

Study Officials

  • MD

    Amgen

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 30, 2005

First Posted

July 19, 2005

Study Start

October 1, 2002

Study Completion

December 1, 2003

Last Updated

December 24, 2007

Record last verified: 2007-12