Recurrent Ovarian Carcinoma
Conditions
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.
Interventions
None listed
Sponsors
Medical University Innsbruck
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 99 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To assess treatment patterns and the reasons for selecting these treatments in patients with platinum-sensitive ROC after first relapse in Austria | Two years | Descriptive Data Analysis |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression Free Survival | 2 years per patient | after first relapse and second relapse, evaluated by clinical practice in each center |
| Overall Survival | 2 years per patient | at 24 months |
| Assess Treatments | 2 years per patient | treatment duration, number of cycle, treatment exposure, time to next treatment |
| Overall Survival Description | 2 years per patient | died due to disease, died due to other reasons, alive |
Countries
Austria
Contacts
Primary ContactAGO Studienzentrale
Outcome results
None listed