Clinical trial NCT00368420: Validation of a Score of Predictive Factors for Complete Resection in Platinum-sensitive Recurrent Ovarian Cancer
Official title: Validation of a Score of Predictive Factors for Complete Resection in Platinum-sensitive Recurrent Ovarian Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ovarian Cancer
Keywords: ovarian cancer
recurrence
surgery
Lead sponsor: AGO Study Group
Sponsor class: OTHER
Collaborators: name: Arbeitsgemeinschaft Gynaekologische Onkologie Austria
name: MITO
First posted: 2006-08-24
Enrollment: 122
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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

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 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Innsbruck
country: Austria
facility: Universitätskliniken LKH Innsbruck
city: Leuven
country: Belgium
facility: University Hospitals Leuven
city: Frankfurt
country: Germany
facility: Klinikum der Johann Wolfgang Goethe Universität
city: Freiburg
country: Germany
facility: Universitätsklinikum Freiburg
city: Karlsruhe
country: Germany
facility: St. Vincentius Kliniken gAG
city: Landshut
country: Germany
facility: Klinikum Landshut gGmbH
city: Lüneburg
country: Germany
facility: Städtisches Krankenhaus Lüneburg
city: Neumarkt
country: Germany
facility: Klinikum Neumarkt
city: Wiesbaden
country: Germany
facility: HSK, Dr. Horst Schmidt Klinik
city: Wolfsburg
country: Germany
facility: Klinikum der Stadt Wolfsburg
city: Campobasso
country: Italy
facility: Catholic University of Sacred Heart
city: Milan
country: Italy
facility: European Institute of Oncology
Study officials:
affiliation: Dr. Horst Schmidt Klinik Wiesbaden
name: Philipp Harter, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Universitäts-Frauenklinik Freiburg
name: Annette Hasenburg, PD Dr.
role: STUDY_CHAIR
affiliation: Dr. Horst Schmidt Klinik Wiesbaden
name: Andreas du Bois, Prof. Dr.
role: STUDY_DIRECTOR
References:
citation: 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.