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

March 27, 2023 updated by: Medical University Innsbruck

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

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.

Study Overview

Status

Recruiting

Conditions

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.

Study Type

Observational

Enrollment (Anticipated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Austria
      • Graz, Austria
        • Recruiting
        • Medical University Graz
        • Contact:
          • Edgar Petru, Prof. Dr.
      • Innsbruck, Austria
        • Recruiting
        • Medical University Innsbruck
        • Contact:
          • Christian Marth, Prof. Dr.
      • Kufstein, Austria
        • Recruiting
        • Bezirkskrankenhaus Kufstein
        • Contact:
          • Rainer Heider, Prim. Dr.
      • Leoben, Austria
        • Recruiting
        • LKH Hochsteiermark
        • Contact:
          • Florentia Peintinger, Prof. PD Dr.
      • Lienz, Austria
        • Recruiting
        • Bezirkskrankenhaus Lienz
        • Contact:
          • Birgit Volgger, Prim. Dr.
      • Linz, Austria
        • Recruiting
        • Kepler Universitätsklinikum Linz
        • Contact:
          • Lukas Angleitner-Boubenizek, OA Dr.
      • Linz, Austria
        • Recruiting
        • Ordensklinikum Linz
        • Contact:
          • Lukas Hefler, Prim. Dr.
      • Ried Im Innkreis, Austria
        • Recruiting
        • Krankenhaus der Barmherzigen Schwestern Ried
        • Contact:
          • Florian Baminger, OA Dr.
      • Vienna, Austria
        • Recruiting
        • Medical University Vienna
        • Contact:
          • Alexander Reinthaller, Prof. Dr.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Two years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression Free Survival
Time Frame: 2 years per patient
after first relapse and second relapse, evaluated by clinical practice in each center
2 years per patient
Overall Survival
Time Frame: 2 years per patient
at 24 months
2 years per patient
Assess Treatments
Time Frame: 2 years per patient
treatment duration, number of cycle, treatment exposure, time to next treatment
2 years per patient
Overall Survival Description
Time Frame: 2 years per patient
died due to disease, died due to other reasons, alive
2 years per patient

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University Innsbruck

Investigators

  • Principal Investigator: Lukas Hefler, Prim. Dr., Ordensklinikum Linz

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 9, 2018

Primary Completion (Anticipated)

December 1, 2024

Study Completion (Anticipated)

August 1, 2025

Study Registration Dates

First Submitted

April 27, 2020

First Submitted That Met QC Criteria

April 27, 2020

First Posted (Actual)

April 30, 2020

Study Record Updates

Last Update Posted (Actual)

March 28, 2023

Last Update Submitted That Met QC Criteria

March 27, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AGO R03 ROC

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Recurrent Ovarian Carcinoma

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Ethiopia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe