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

This study has been completed.
Sponsor:
Collaborators:
Arbeitsgemeinschaft Gynaekologische Onkologie Austria
MITO
Information provided by:
AGO Study Group
ClinicalTrials.gov Identifier:
NCT00368420
First received: August 23, 2006
Last updated: February 11, 2011
Last verified: February 2011
  Purpose

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


Condition
Ovarian Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Validation of a Score of Predictive Factors for Complete Resection in Platinum-sensitive Recurrent Ovarian Cancer

Resource links provided by NLM:


Further study details as provided by AGO Study Group:

Enrollment: 122
Study Start Date: September 2006
Study Completion Date: October 2009
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   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.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00368420

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

No publications provided

ClinicalTrials.gov Identifier: NCT00368420     History of Changes
Other Study ID Numbers: AGO-OVAR OP.2, AGO DESKTOP OVAR II
Study First Received: August 23, 2006
Last Updated: February 11, 2011
Health Authority: Germany: Ethics Commission

Keywords provided by AGO Study Group:
ovarian cancer
recurrence
surgery

Additional relevant MeSH terms:
Ovarian Neoplasms
Adnexal Diseases
Endocrine Gland Neoplasms
Endocrine System Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Gonadal Disorders
Neoplasms
Neoplasms by Site
Ovarian Diseases
Urogenital Neoplasms

ClinicalTrials.gov processed this record on October 23, 2014