NCT00368420

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 122 (actual)
• Sponsor: AGO Study Group · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Ovarian Cancer

Timeline

• Start date: 2006-09-01
• Primary completion: 2008-07-01
• Completion: 2009-10-01
• First posted: 2006-08-24
• Last updated: 2011-02-15

Locations

12 sites across 4 countries: Austria, Belgium, Germany, Italy