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Survey on the Treatment of Anemia Using Recombinant Human Erythropoietin 2 (STAR-2)

5. november 2012 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

1927

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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.

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Tidsperspektiver: Fremadrettet

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
Epoetin alfa
Epoetin alfa 40 000 IU once weekly variable treatment length
40,000 IU once weekly, variable treatment length

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
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
Tidsramme: 4 weeks, 8 weeks and end of treatment
4 weeks, 8 weeks and end of treatment

Sekundære resultatmål

Resultatmål
Tidsramme
Incidence of adverse events
Tidsramme: from start epoetin treatment to end of study
from start epoetin treatment to end of study

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. oktober 2005

Primær færdiggørelse (Faktiske)

1. november 2009

Studieafslutning (Faktiske)

1. november 2009

Datoer for studieregistrering

Først indsendt

10. november 2006

Først indsendt, der opfyldte QC-kriterier

10. november 2006

Først opslået (Skøn)

14. november 2006

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

6. november 2012

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

5. november 2012

Sidst verificeret

1. november 2012

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CR005596
  • EPOCAN4018

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Neoplasmer

Kliniske forsøg med Epoetin alfa

3
Abonner