Validation of a Score of Predictive Factors for Complete Resection in Platinum-sensitive Recurrent Ovarian Cancer
NCT ID: NCT00368420
Last Updated: 2011-02-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
122 participants
OBSERVATIONAL
2006-09-30
2009-10-31
Brief Summary
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Detailed Description
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* 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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* Women aged \> 18 years
* Patients who have given their signed and written informed consent to data transmission and -processing
Exclusion Criteria
* 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
18 Years
FEMALE
No
Sponsors
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Arbeitsgemeinschaft Gynaekologische Onkologie Austria
OTHER
MITO
UNKNOWN
AGO Study Group
OTHER
Principal Investigators
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Philipp Harter, Dr.
Role: PRINCIPAL_INVESTIGATOR
Dr. Horst Schmidt Klinik Wiesbaden
Annette Hasenburg, PD Dr.
Role: STUDY_CHAIR
Universitäts-Frauenklinik Freiburg
Andreas du Bois, Prof. Dr.
Role: STUDY_DIRECTOR
Dr. Horst Schmidt Klinik Wiesbaden
Locations
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Universitätskliniken LKH Innsbruck
Innsbruck, , Austria
University Hospitals Leuven
Leuven, , Belgium
Klinikum der Johann Wolfgang Goethe Universität
Frankfurt, , Germany
Universitätsklinikum Freiburg
Freiburg im Breisgau, , Germany
St. Vincentius Kliniken gAG
Karlsruhe, , Germany
Klinikum Landshut gGmbH
Landshut, , Germany
Städtisches Krankenhaus Lüneburg
Lüneburg, , Germany
Klinikum Neumarkt
Neumarkt, , Germany
HSK, Dr. Horst Schmidt Klinik
Wiesbaden, , Germany
Klinikum der Stadt Wolfsburg
Wolfsburg, , Germany
Catholic University of Sacred Heart
Campobasso, , Italy
European Institute of Oncology
Milan, , Italy
Countries
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References
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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.
Other Identifiers
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AGO DESKTOP OVAR II
Identifier Type: -
Identifier Source: secondary_id
AGO-OVAR OP.2
Identifier Type: -
Identifier Source: org_study_id
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