Survey on the Treatment of Anemia Using Recombinant Human Erythropoietin 2 (STAR-2)
2 other identifiers
observational
1,927
0 countries
N/A
Brief Summary
The main purpose of this study is to evaluate the safety and efficacy (% response) of epoetin alfa in the treatment of anemia in adults receiving chemotherapy for cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2005
Longer than P75 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2005
CompletedFirst Submitted
Initial submission to the registry
November 10, 2006
CompletedFirst Posted
Study publicly available on registry
November 14, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2009
CompletedNovember 6, 2012
November 1, 2012
4.1 years
November 10, 2006
November 5, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The assessment of effectiveness based on: epoetin alfa treatment schedule (dose and timing), hemoglobin effect, response to treatment (independent of blood transfusion), mean time to response, # of blood transfusions given, and iron supplementation
4 weeks, 8 weeks and end of treatment
Secondary Outcomes (1)
Incidence of adverse events
from start epoetin treatment to end of study
Study Arms (1)
Epoetin alfa
Epoetin alfa 40 000 IU once weekly variable treatment length
Interventions
Eligibility Criteria
Cancer patients receiving epoetin alfa as anemia treatment during chemotherapy, as part of the common practice of participating physicians. Patients may enter the study as soon as their epoetin alfa treatment starts.
You may qualify if:
- Patients with a diagnosis of solid tumors, multiple myeloma (Kahlers' disease), non-Hodgkin lymphoma or Hodgkins' disease
- Patients must already be receiving chemotherapy or start their first cycle within a week of enrollment
- Patients must receive epoetin alfa treatment (expected treatment duration is at least 4 weeks)
You may not qualify if:
- Patients who cannot read the Dutch language and/or do not understand the Dutch Informed Consent Form and patients participating in either of our observational studies, EVALUATE or COMPARE
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Janssen-Cilag B.V. Clinical Trial
Janssen-Cilag B.V.
Study Design
- Study Type
- observational
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 10, 2006
First Posted
November 14, 2006
Study Start
October 1, 2005
Primary Completion
November 1, 2009
Study Completion
November 1, 2009
Last Updated
November 6, 2012
Record last verified: 2012-11