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

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ClinicalTrials.gov Identifier: NCT00368420
Recruitment Status : Completed
First Posted : August 24, 2006
Last Update Posted : February 15, 2011
Sponsor:
Collaborators:
Arbeitsgemeinschaft Gynaekologische Onkologie Austria
MITO
Information provided by:
AGO Study Group

Tracking Information
First Submitted Date August 23, 2006
First Posted Date August 24, 2006
Last Update Posted Date February 15, 2011
Study Start Date September 2006
Actual Primary Completion Date July 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Ovarian Cancer
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * 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 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: August¬†23,¬†2006)
122
Original Enrollment Same as current
Actual Study Completion Date October 2009
Actual Primary Completion Date July 2008   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: Female
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Austria,   Belgium,   Germany,   Italy
Removed Location Countries  
 
Administrative Information
NCT Number NCT00368420
Other Study ID Numbers AGO-OVAR OP.2
AGO DESKTOP OVAR II
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Not Provided
Study Sponsor AGO Study Group
Collaborators
  • 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
PRS Account AGO Study Group
Verification Date February 2011