Clinical trial NCT04369352: Register to Describe the Treatment Pattern of Platinum-sensitive Relapsed Epithelial Ovarian Cancer Patients in Austria
Official title: Non-interventional, Multicenter, Prospective Register Study to Describe the Treatment Pattern of Platinum-sensitive Relapsed Epithelial Ovarian Cancer (ROC) Patients in Austria
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Recurrent Ovarian Carcinoma
Lead sponsor: Medical University Innsbruck
Sponsor class: OTHER
First posted: 2020-04-30
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients at their first platinum-sensitive ROC treated within gynecological oncology centers in Austria participating in the register.

Brief summary: Various treatment options exist for patients with platinum-sensitive relapsed epithelial ovarian cancer (ROC).

The register will provide an overview of chosen treatments including the reasons, why these options were chosen.

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.

Eligibility criteria: 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

Primary outcomes:
measure: To assess treatment patterns and the reasons for selecting these treatments in patients with platinum-sensitive ROC after first relapse in Austria
timeFrame: Two years
Secondary outcomes:
measure: Progression Free Survival
timeFrame: 2 years per patient
measure: Overall Survival
timeFrame: 2 years per patient
measure: Assess Treatments
timeFrame: 2 years per patient
measure: Overall Survival Description
timeFrame: 2 years per patient
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Medical University Graz
city: Innsbruck
country: Austria
facility: Medical University Innsbruck
city: Kufstein
country: Austria
facility: Bezirkskrankenhaus Kufstein
city: Leoben
country: Austria
facility: LKH Hochsteiermark
city: Lienz
country: Austria
facility: Bezirkskrankenhaus Lienz
city: Linz
country: Austria
facility: Kepler Universitätsklinikum Linz
city: Linz
country: Austria
facility: Ordensklinikum Linz
city: Ried Im Innkreis
country: Austria
facility: Krankenhaus der Barmherzigen Schwestern Ried
city: Vienna
country: Austria
facility: Medical University Vienna
Study officials:
affiliation: Ordensklinikum Linz
name: Lukas Hefler, Prim. Dr.
role: PRINCIPAL_INVESTIGATOR
References: