NCT00368420

Brief Summary

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

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
122

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2006

Typical duration for all trials

Geographic Reach
4 countries

12 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 23, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 24, 2006

Completed
8 days until next milestone

Study Start

First participant enrolled

September 1, 2006

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2008

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed
Last Updated

February 15, 2011

Status Verified

February 1, 2011

Enrollment Period

1.8 years

First QC Date

August 23, 2006

Last Update Submit

February 11, 2011

Conditions

Ovarian Cancer

Keywords

ovarian cancerrecurrencesurgery

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Universitätskliniken LKH Innsbruck

Innsbruck, 6020, Austria

Location

University Hospitals Leuven

Leuven, 3000, Belgium

Location

Klinikum der Johann Wolfgang Goethe Universität

Frankfurt, 60596, Germany

Location

Universitätsklinikum Freiburg

Freiburg im Breisgau, 79106, Germany

Location

St. Vincentius Kliniken gAG

Karlsruhe, 76135, Germany

Location

Klinikum Landshut gGmbH

Landshut, 84034, Germany

Location

Städtisches Krankenhaus Lüneburg

Lüneburg, 21339, Germany

Location

Klinikum Neumarkt

Neumarkt, 92318, Germany

Location

HSK, Dr. Horst Schmidt Klinik

Wiesbaden, 65199, Germany

Location

Klinikum der Stadt Wolfsburg

Wolfsburg, 38440, Germany

Location

Catholic University of Sacred Heart

Campobasso, 86100, Italy

Location

European Institute of Oncology

Milan, 20141, Italy

Location

Related Publications (1)

  • 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.

    PMID: 21270612RESULT

MeSH Terms

Conditions

Ovarian NeoplasmsRecurrence

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal DisordersDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Philipp Harter, Dr.

    Dr. Horst Schmidt Klinik Wiesbaden

    PRINCIPAL INVESTIGATOR

  • Annette Hasenburg, PD Dr.

    Universitäts-Frauenklinik Freiburg

    STUDY CHAIR

  • Andreas du Bois, Prof. Dr.

    Dr. Horst Schmidt Klinik Wiesbaden

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 23, 2006

First Posted

August 24, 2006

Study Start

September 1, 2006

Primary Completion

July 1, 2008

Study Completion

October 1, 2009

Last Updated

February 15, 2011

Record last verified: 2011-02

Locations

AU(1)BE(1)IT(2)DE(8)