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

Recurrent Ovarian Carcinoma Clinical Trial

Official title:

Non-interventional, Multicenter, Prospective Register Study to Describe the Treatment Pattern of Platinum-sensitive Relapsed Epithelial Ovarian Cancer (ROC) Patients in Austria

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04369352
• Other study ID #: AGO R03 ROC
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Recurrent Ovarian Carcinoma

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