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CompletedNCT00368420Updated Feb 15, 2011

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

An observational study in Ovarian Cancer, sponsored by AGO Study Group. Completed at 12 sites in 4 countries. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-02-15.

Sponsored by AGO Study Group · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
122
Ages
18 Years and older
Sex
Female
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Study summary

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

Read the 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.

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Conditions studied

  • Ovarian Cancer

Keywords

  • ovarian cancer
  • recurrence
  • surgery
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In context

Ovarian Neoplasms

2,695 studies on the registry are indexed under Ovarian Neoplasms; 727 are open to participants now.

This study's enrollment of 122 is below the median of 200 across 527 observational studies indexed under Ovarian Neoplasms.

Browse Ovarian Neoplasms studies →

Lead sponsor

AGO Study Group is the lead sponsor of 23 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

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.

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

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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
122 participants (actual)
06

Study locations

12 sites
  • Universitätskliniken LKH Innsbruck
    Innsbruck, 6020, Austria
  • University Hospitals Leuven
    Leuven, 3000, Belgium
  • Klinikum der Johann Wolfgang Goethe Universität
    Frankfurt, 60596, Germany
  • Universitätsklinikum Freiburg
    Freiburg, 79106, Germany
  • St. Vincentius Kliniken gAG
    Karlsruhe, 76135, Germany
  • Klinikum Landshut gGmbH
    Landshut, 84034, Germany
  • Städtisches Krankenhaus Lüneburg
    Lüneburg, 21339, Germany
  • Klinikum Neumarkt
    Neumarkt, 92318, Germany
  • HSK, Dr. Horst Schmidt Klinik
    Wiesbaden, 65199, Germany
  • Klinikum der Stadt Wolfsburg
    Wolfsburg, 38440, Germany
  • Catholic University of Sacred Heart
    Campobasso, 86100, Italy
  • European Institute of Oncology
    Milan, 20141, Italy
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References and documents

Publications

  • Harter P, Sehouli J, Reuss A, Hasenburg A, Scambia G, Cibula D, Mahner S, Vergote I, Reinthaller A, Burges A, Hanker L, Polcher M, Kurzeder C, Canzler U, Petry KU, Obermair A, Petru E, Schmalfeldt B, Lorusso D, du Bois A. Prospective validation study of a predictive score for operability of recurrent ovarian cancer: the Multicenter Intergroup Study DESKTOP II. A project of the AGO Kommission OVAR, AGO Study Group, NOGGO, AGO-Austria, and MITO. Int J Gynecol Cancer. 2011 Feb;21(2):289-95. doi: 10.1097/IGC.0b013e31820aaafd. PubMed 21270612 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 15, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00368420
Lead sponsor
AGO Study Group
Collaborators
Arbeitsgemeinschaft Gynaekologische Onkologie Austria, MITO
First posted
Aug 24, 2006
Start date
Sep 2006
Primary completion
Jul 2008
Completion
Oct 2009
Last update
Feb 15, 2011

Study contacts

Philipp Harter, Dr.
principal investigator · Dr. Horst Schmidt Klinik Wiesbaden
Annette Hasenburg, PD Dr.
study chair · Universitäts-Frauenklinik Freiburg
Andreas du Bois, Prof. Dr.
study director · Dr. Horst Schmidt Klinik Wiesbaden

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2011. You cannot join it, but the record below documents what was studied.

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