AnemiaNCT00398749
Survey on the Treatment of Anemia Using Recombinant Human Erythropoietin 2 (STAR-2)
An observational study of Anemia and Neoplasms, run by Janssen-Cilag B.V..
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Epoetin alfa
- How many people
- 1,927 participants
- Where
- No sites listed yet
- Study dates
- Oct 2005to Nov 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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)
Who cannot join
- 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
About this study
Official title: 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.
Read the 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.
- Being tested
- Epoetin alfa
- Keywords
- Anemia, Neoplasms, Antineoplastic agents, Chemotherapy, Efficacy, Epoetin alfa
- Medical subject headings
- Anemia, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epoetin alfaDrug
40,000 IU once weekly, variable treatment length
| Study group | Role | What they receive |
|---|---|---|
| Epoetin alfa | Epoetin alfa 40 000 IU once weekly variable treatment length Receives: Drug: Epoetin alfa |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 4 weeks, 8 weeks and end of treatment
Secondary outcomes (1)
Incidence of adverse events
Measured: from start epoetin treatment to end of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2006 (estimated)
- Study startOct 2005
- Primary completionNov 2009
- Study completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 1,927 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen-Cilag B.V.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen-Cilag B.V. Clinical Trial, Study director, Janssen-Cilag B.V.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00398749
- Sponsor's protocol ID
- CR005596
- Other IDs
- EPOCAN4018
- Status last verified
- Nov 2012
- First submitted
- 10 Nov 2006
- Last updated
- 6 Nov 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Survey on the Treatment of Anemia Using Recombinant Human Erythropoietin 2
- ClinicalTrials.gov ID
- NCT00398749
- Acronym / sponsor ID
- CR005596
- Keywords
- Anemia, Neoplasms, Antineoplastic agents, Chemotherapy, Efficacy, Epoetin alfa
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,927 participants (actual)
- Lead sponsor
- Janssen-Cilag B.V.Industry (pharma, biotech, devices)
- Study start
- Oct 2005
- Primary completion
- Nov 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 14 Nov 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Epoetin alfa | – | Drug: Epoetin alfaEpoetin alfa 40 000 IU once weekly variable treatment length |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Epoetin alfa40,000 IU once weekly, variable treatment length | Drug | Epoetin alfa |
Primary outcome
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
1 secondary outcome
Incidence of adverse events
Time frame: from start epoetin treatment to end of study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2012.
- Survey on the Treatment of Anemia Using Recombinant Human Erythropoietin 2 (STAR-2)Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janssen-Cilag B.V. Clinical Trial study director
Janssen-Cilag B.V.
Questions about this trial
What is this clinical trial studying?
An observational study of Anemia and Neoplasms, run by Janssen-Cilag B.V..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2012.