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

Completed

• Conditions: Ovarian Cancer

• Registration Number: NCT00368420
• Lead Sponsor: AGO Study Group

Brief 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.

Study Timeline

• Study First Submitted: 2006-08-23
• Study First Submitted QC: 2006-08-23
• Study First Posted: 2006-08-24
• Study Start: 2006-09
• Primary Completion: 2008-07
• Study Completion: 2009-10
• Status Verified: 2011-02
• Last Update Submitted: 2011-02-11
• Last Update Posted: 2011-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 122

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (12)

Universitätskliniken LKH Innsbruck; 🇦🇹 Innsbruck, Austria

Klinikum Neumarkt; 🇩🇪 Neumarkt, Germany

University Hospitals Leuven; 🇧🇪 Leuven, Belgium

St. Vincentius Kliniken gAG; 🇩🇪 Karlsruhe, Germany

Klinikum der Johann Wolfgang Goethe Universität; 🇩🇪 Frankfurt, Germany

Universitätsklinikum Freiburg; 🇩🇪 Freiburg, Germany

Klinikum der Stadt Wolfsburg; 🇩🇪 Wolfsburg, Germany

European Institute of Oncology; 🇮🇹 Milan, Italy

HSK, Dr. Horst Schmidt Klinik; 🇩🇪 Wiesbaden, Germany

Catholic University of Sacred Heart; 🇮🇹 Campobasso, Italy

Städtisches Krankenhaus Lüneburg; 🇩🇪 Lüneburg, Germany

Klinikum Landshut gGmbH; 🇩🇪 Landshut, Germany