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

Ovarian Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00368420
• Other study ID #: AGO-OVAR OP.2
• Secondary ID: AGO DESKTOP OVAR
• Status: Completed
• Phase: N/A
• First received: August 23, 2006
• Last updated: February 11, 2011
• Start date: September 2006
• Est. completion date: October 2009

Study information

• Verified date: February 2011
• Source: AGO Study Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 122
• Est. completion date: October 2009
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Ovarian Cancer
• Ovarian Neoplasms

Locations

Country	Name	City	State
Austria	Universitätskliniken LKH Innsbruck	Innsbruck
Belgium	University Hospitals Leuven	Leuven
Germany	Klinikum der Johann Wolfgang Goethe Universität	Frankfurt
Germany	Universitätsklinikum Freiburg	Freiburg
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
Italy	Catholic University of Sacred Heart	Campobasso
Italy	European Institute of Oncology	Milan

Sponsors (3)

Lead Sponsor	Collaborator
AGO Study Group	Arbeitsgemeinschaft Gynaekologische Onkologie Austria, MITO

Countries where clinical trial is conducted

Austria,  Belgium,  Germany,  Italy, 

References & Publications (1)

Harter P, Sehouli J, Reuss A, Hasenburg A, Scambia G, Cibula D, Mahner S, Vergote I, Reinthaller A, Burges A, Hanker L, Pölcher M, Kurzeder C, Canzler U, Petry KU, Obermair A, Petru E, Schmalfeldt B, Lorusso D, du Bois A. Prospective validation study of a — View Citation