Survey on the Treatment of Anemia Using Recombinant Human Erythropoietin 2 (STAR-2)
November 5, 2012 updated by: Janssen-Cilag B.V.
Survey on the Treatment of Anemia Using Recombinant Human Erythropoietin 2
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.
Study Overview
Detailed Description
Anemia has been identified as a common complication and a widespread problem in the cancer population.
Anemia is a condition in which a patient has below normal levels of hemoglobin, the substance in red blood cells that carries oxygen to all parts of the body.
People with severe anemia may experience fatigue and shortness of breath with activity.
Therefore, this condition can have a negative influence on a person's quality of life.
Epoetin alfa, used to treat anemia in cancer patients, is a genetically engineered protein that stimulates red blood cell production.
This study investigates treatment of anemia using epoetin alfa during chemotherapy in adult patients with cancer.
The study is intended to collect information on normal medical practice and routine anemia management performed at the participating centers.
This is an observational, non-randomized, prospective, comparative, parallel-group survey performed in The Netherlands.
Patients with various severities of disease may enter the survey as soon as their epoetin alfa treatment starts and will be followed until the end of their epoetin alfa treatment.
Patient data are collected in Case Report Forms (CRFs) until 4 weeks after the end of treatment with epoetin alfa.
At the end of treatment completed CRFs will be collected.
The assessment of effectiveness/response will be based on the following: cancer type and status, chemotherapy and other anti-cancer treatment, hemoglobin levels, use of blood transfusions, and serum iron levels and iron supplementation.
Safety evaluations include the incidence of serious and non-serious adverse events.
Because the study is observational, dosage, administration and duration of treatment is at discretion of treating physician.
Study Type
Observational
Enrollment (Actual)
1927
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
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.
Description
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Epoetin alfa
Epoetin alfa 40 000 IU once weekly variable treatment length
|
40,000 IU once weekly, variable treatment length
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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
Time Frame: 4 weeks, 8 weeks and end of treatment
|
4 weeks, 8 weeks and end of treatment
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Incidence of adverse events
Time Frame: from start epoetin treatment to end of study
|
from start epoetin treatment to end of study
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2005
Primary Completion (Actual)
November 1, 2009
Study Completion (Actual)
November 1, 2009
Study Registration Dates
First Submitted
November 10, 2006
First Submitted That Met QC Criteria
November 10, 2006
First Posted (Estimate)
November 14, 2006
Study Record Updates
Last Update Posted (Estimate)
November 6, 2012
Last Update Submitted That Met QC Criteria
November 5, 2012
Last Verified
November 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CR005596
- EPOCAN4018
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.