Validation of a Score of Predictive Factors for Complete Resection in Platinum-sensitive Recurrent Ovarian Cancer

AGO Study Group122 enrolled

Overview

The purpose of this study is to validate a score developed by the AGO-OVAR for complete resection of the tumor

The multicentre retrospective study AGO-DESKTOP OVAR 1 investigated in a multicentre-setting the question of prognostic factors for a successful (i.e. complete) debulking for recurrence. That way, a hypothesis for a score with 3 factors could be developed: * PS ECOG = 0 * tumor-free after primary surgery (if unknown: FIGO I/II) * Ascites \< 500 ml. The goal of this study is to evaluate in a prospective multicentre setting, to what extent this retrospectively defined AGO-score has predictive validity. The criterion aimed at is therefore the rate of complete tumor resections if the three score characteristics are present in invasive epithelial platinum-sensitive ovarian-, fallopian tube- or primary peritoneal cancer. This study will be the second in a series of three: (1) hypothesis building for a potential predictive score for resectability, (2) prospective confirmation of the AGO-score, and (3) application of the AGO-score as inclusion criteria for eligible patients in whom a formal comparison of the role of secondary debulking of relapsed ovarian cancer could be performed.

Study Type

OBSERVATIONAL

Enrollment

122

Conditions

Ovarian Cancer

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients with recurrence of invasive epithelial ovarian-, fallopian tube- or primary peritoneal cancer of any initial stage who have relapsed after a tumor-free interval of at least 6 months after completion of first-line therapy. The same interval applies to patients with second relapse who are enrolled after completed platinum-containing re-induction therapy. * Women aged \> 18 years * Patients who have given their signed and written informed consent to data transmission and -processing Exclusion Criteria: * Patients with non-epithelial tumors as well as borderline tumors * Patients who undergo second-look surgery or completion surgery after end of chemotherapy or during the interval * Only for the study collective: patients with second malignancies who have been treated by laparotomy, as well as other neoplasias, if the treatment could interfere with the treatment of relapsed ovarian cancer * Patients with a third recurrence * Patients with so-called platinum-refractory tumor, i.e. progression during chemotherapy or recurrence within 6 months after end of former platinum-containing therapy

Locations (12)

Universitätskliniken LKH Innsbruck

Innsbruck, Austria

University Hospitals Leuven

Leuven, Belgium

Klinikum der Johann Wolfgang Goethe Universität

Frankfurt, Germany

Data from ClinicalTrials.gov

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