CAOS - An open, randomized, multicenter study in patients with recurrent epithelial ovarian cancer, primary peritoneal cancer or fallopian tube cancer to compare the efficacy and safety of paclitaxel (micellar) nanoparticles and paclitaxel
CAOS - An open, randomized, multicenter study in patients with recurrent epithelial ovarian cancer, primary peritoneal cancer or fallopian tube cancer to compare the efficacy and safety of paclitaxel (micellar) nanoparticles and paclitaxel
Project number : 246301
Created by: Ylva Storck, 2018-03-27
Last revised by: Ylva Storck, 2018-03-27
Project created in: FoU Region Örebro län

CompletedCompleted
2009-05-25
Rekrytering/datainsamling pågår
2015-12-31
Projektet avslutat

Registeranmälan

  1. CAOS - An open, randomized, multicenter study in patients with recurrent epithelial ovarian cancer, primary peritoneal cancer or fallopian tube cancer to compare the efficacy and safety of paclitaxel (micellar) nanoparticles and paclitaxel, PUL-anmälan
  2. CAOS - An open, randomized, multicenter study in patients with recurrent epithelial ovarian cancer, primary peritoneal cancer or fallopian tube cancer to compare the efficacy and safety of paclitaxel (micellar) nanoparticles and paclitaxel, Projektbeskrivning

Titel och sammanfattning

Populärvetenskaplig sammanfattning

En klinisk studie som jämför effekt och säkerhet mellan Paclical och Taxol. Patienter med äggstockscancer, äggledarcancer eller bukhinnecancer kommer att deltaga.

Projektspecifik information

Ämnesord

checked Cancer och onkologi


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Studietyp

Prövning av läkemedel

Fas

III

Randomiserad studie

Ja

Diagnoskod för huvuddiagnos

C51-C58 Maligna tumörer i de kvinnliga könsorganen

Multicenterstudie

Ja

EudraCTnr

2008-002668-32

Protokollnummer på prövningen

OAS-07OVA

Etikprövningsmyndighetens diarienummer

2009/24

Biobanksavtal

Ej aktuellt

Inklusionsstatus

 Planerat antalAntal tillfrågadeScreen-failureAntal randominserade
n= 6 screenade 2

Vetenskaplig sammanfattning

Primary objective: to show non-inferiority of the experimental treatment and the control treatment in terms of change in AUC based treatment Cav of CA 125 relative to predose Cav of CA 125, to show non-inferiority of the experimental treatment and the control treatment in terms of progression.free survival, to show superiority of the experimental treatment over the control treatment in terms of the incidence and severity of hypersensitivity reactions

Involverade parter

Arbetsplats

Added workplaces

Regioner - Region Örebro Län - Hälso- och sjukvård - Område opererande och onkologi - Onkologiska kliniken workplace verified by Region Örebro län on 2018-06-14

Sponsor

Added workplaces

Företag - Läkemedel etc - Övrigt

Nationell koordinator

Added workplaces

Regioner - Region Skåne - Specialiserad vård - Universitetssjukhuset i Lund

Medarbetare i projektet

Louise Bohr Mordhorst
MD, phD, Onkologiska kliniken

Roll i projektet

checked PI (huvudprövare eller ansvarig forskare)

CAOS - An open, randomized, multicenter study in patients with recurrent epithelial ovarian cancer, primary peritoneal cancer or fallopian tube cancer to compare the efficacy and safety of paclitaxel (micellar) nanoparticles and paclitaxel, from FoU Region Örebro län
http://www.researchweb.org/is/en/fourol/project/246301