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

AGO Study Group

Status: Completed

Conditions: Ovarian Cancer

Study type: Observational

Funder types: Other

Identifiers

NCT00368420

AGO-OVAR OP.2

AGO DESKTOP OVAR II

Details and patient eligibility

About

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

Full description

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.

Enrollment: 122 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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