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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04369352
Other study ID # AGO R03 ROC
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date August 9, 2018
Est. completion date August 2025

Study information

Verified date March 2023
Source Medical University Innsbruck
Contact AGO Studienzentrale
Phone 0043 512 504 24132
Email ago.studienzentrale@i-med.ac.at
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 150
Est. completion date August 2025
Est. primary completion date December 2024
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 99 Years
Eligibility 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

Study Design


Locations

Country Name City State
Austria Medical University Graz Graz
Austria Medical University Innsbruck Innsbruck
Austria Bezirkskrankenhaus Kufstein Kufstein
Austria LKH Hochsteiermark Leoben
Austria Bezirkskrankenhaus Lienz Lienz
Austria Kepler Universitätsklinikum Linz Linz
Austria Ordensklinikum Linz Linz
Austria Krankenhaus der Barmherzigen Schwestern Ried Ried Im Innkreis
Austria Medical University Vienna Vienna

Sponsors (1)

Lead Sponsor Collaborator
Medical University Innsbruck

Country where clinical trial is conducted

Austria, 

Outcome

Type Measure Description Time frame Safety issue
Primary To assess treatment patterns and the reasons for selecting these treatments in patients with platinum-sensitive ROC after first relapse in Austria Descriptive Data Analysis Two years
Secondary Progression Free Survival after first relapse and second relapse, evaluated by clinical practice in each center 2 years per patient
Secondary Overall Survival at 24 months 2 years per patient
Secondary Assess Treatments treatment duration, number of cycle, treatment exposure, time to next treatment 2 years per patient
Secondary Overall Survival Description died due to disease, died due to other reasons, alive 2 years per patient
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