Clinical Trial on Ovarian Cancer - Clinical Trials Registry

Study Overview

Status

Completed

Conditions

Ovarian Cancer

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 Type

Observational

Enrollment (Actual)

122

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Observational Models: Cohort
Time Perspectives: Prospective

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AGO Study Group

Collaborators

Arbeitsgemeinschaft Gynaekologische Onkologie Austria

MITO

Investigators

Principal Investigator: Philipp Harter, Dr., Dr. Horst Schmidt Klinik Wiesbaden
Study Chair: Annette Hasenburg, PD Dr., Universitäts-Frauenklinik Freiburg
Study Director: Andreas du Bois, Prof. Dr., Dr. Horst Schmidt Klinik Wiesbaden

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General 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.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2006

Primary Completion (Actual)

July 1, 2008

Study Completion (Actual)

October 1, 2009

Study Registration Dates

First Submitted

August 23, 2006

First Submitted That Met QC Criteria