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

M

Medical University Innsbruck

Status

Enrolling

Conditions

Recurrent Ovarian Carcinoma

Study type

Observational

Funder types

Other

Identifiers

NCT04369352
AGO R03 ROC

Details and patient eligibility

About

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.

Full 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.

Enrollment

150 estimated patients

Sex

Female

Ages

18 to 99 years old

Volunteers

No Healthy Volunteers

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

Trial contacts and locations

9

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Central trial contact

AGO Studienzentrale

Data sourced from clinicaltrials.gov

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