Skip to main content
OpenTrials
Completed

NCT Number: NCT00368420

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

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

Completed

Looking for future studies?

Notify Me

Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Sponsors and collaborators

Lead sponsor

AGO Study Group

Other

Collaborators

  • Arbeitsgemeinschaft Gynaekologische Onkologie Austria
  • MITO

Registry information

Important dates

Study start
2006
Primary completion
2008
Study completion
2009
First posted
Aug 24, 2006
Registry last updated
Feb 15, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.