About this trial
The purpose of the project is to set up a national, prospective, longitudinal, multicenter cohort study, a tumor registry platform, to document uniform data on characteristics, molecular diagnostics, treatment and course of disease, to collect patient-reported outcomes and to establish a decentralized biobank for patients with advanced or metastatic ovarian cancer (OC) or advanced or metastatic endometrial cancer (EC) in Germany.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
patients with FIGO stage IIb-IV OC who are starting systemic treatment or
patients with recurrent/relapsed disease, who received any previous systemic anti-tumor treatment and who are now starting systemic treatment for recurrent/relapsed disease.
Locally advanced and inoperable or metastatic EC (FIGO stage III-IV) who are starting systemic first-line therapy.
Patients participating in PRO module: IC before first therapy cycle
Disqualifiers
newly diagnosed early-stage OC (FIGO stage I-IIa)
Low grade mOC OR
Early-stage EC (FIGO stage I-II)
Trial population
Adult female patients with (metastatic) ovarian cancer (FIGO stage IIb-IV) or (metastatic) endometrial cancer (FIGO stage III-IV) starting systemic treatment.
Trial design
Other
Prospective
Treatments tested in this trial
Physician's choice according to patient's needs.
Other interventionRoutine care as per site standard.
Treatment groups
Trial outcomes
Primary outcomes
Course of treatment (treatment reality).
Documentation of anamnestic data and therapy sequences.
Secondary outcomes
Best Response.
Documentation of response rates per line of treatment.
Progression-free survival.
Documentation of progression-free survival per line of treatment.
Overall survival.
Documentation of overall survival per line of treatment.
Health-related quality of life (Patient-reported outcome, PRO).
Functional Assessment of Cancer Therapy - Ovarian (FACT-O), a 39 item questionnaire covering Physical Well-Being, Social/Family Well-Being, Emotional Well-Being, Functional Well-Being and Ovarian Cancer Subscale
Locations
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Sponsors and contacts
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