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JOURNAL ONKOLOGIE – STUDIE

Register to Describe the Treatment Pattern of Platinum-sensitive Relapsed Epithelial Ovarian Cancer Patients in Austria

Rekrutierend

NCT-Nummer:
NCT04369352

Studienbeginn:
August 2018

Letztes Update:
28.03.2023

Wirkstoff:
-

Indikation (Clinical Trials):
Carcinoma, Ovarian Epithelial

Geschlecht:
Frauen

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
Medical University Innsbruck

Collaborator:
-

Studienleiter

Lukas Hefler, Prim. Dr.
Principal Investigator
Ordensklinikum Linz

Kontakt

Studienlocations
(3 von 9)

Alle anzeigen

Studien-Informationen

Detailed Description:

Patients at their first platinum-sensitive ROC will be invited to participate in the

register.

These are all patients with recurrent disease 6 or more months after the last cycle of

platinum containing chemotherapy.

The Observation Period will begin by signing the Informed Consent Form (ICF) and will

continue for up to a total of 24 months (+/- 4 weeks) after the diagnosis of the first

relapse or until patient discontinuation for any reason, or patient's death.

Data on First Study Visit, Subsequent Recurrence during Observation Period and Last

Observation will be collected in the electronic Case Report Form (eCRF).

The register will identify symptoms and factors that led to the diagnosis, chosen therapy and

the reason for choosing the therapy. At inclusion, data on general patient information,

primary diagnosis, previous therapy, and tumor characteristics are collected. During the

course of observation data on systemic and maintenance treatments, radiotherapies, surgeries,

and outcome are documented.

Ein-/Ausschlusskriterien

Inclusion Criteria:

- Women aged 18 years or older

- Presence of first platinum-sensitive ROC (ovarian, peritoneal and/or fallopian tube

cancer)

- Must have received at least 4 cycles of chemotherapy during primary therapy

- At time of inclusion a treatment for ROC must be planned

- Patients must not have more than 1 prior line of chemotherapy

- Signed informed consent

Exclusion Criteria:

- No knowledge of spoken and written German

- Signed informed consent is not given

Studien-Rationale

Primary outcome:

1. To assess treatment patterns and the reasons for selecting these treatments in patients with platinum-sensitive ROC after first relapse in Austria (Time Frame - Two years):
Descriptive Data Analysis



Secondary outcome:

1. Progression Free Survival (Time Frame - 2 years per patient):
after first relapse and second relapse, evaluated by clinical practice in each center

2. Overall Survival (Time Frame - 2 years per patient):
at 24 months

3. Assess Treatments (Time Frame - 2 years per patient):
treatment duration, number of cycle, treatment exposure, time to next treatment

4. Overall Survival Description (Time Frame - 2 years per patient):
died due to disease, died due to other reasons, alive

Quelle: ClinicalTrials.gov


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