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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00368420
Enrollment
122
Registered
2006-08-24
Start date
2006-09-30
Completion date
2009-10-31
Last updated
2011-02-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ovarian Cancer

Keywords

ovarian cancer, recurrence, surgery

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.

Interventions

None listed

Sponsors

Arbeitsgemeinschaft Gynaekologische Onkologie Austria
CollaboratorOTHER
MITO
CollaboratorUNKNOWN
AGO Study Group
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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

Countries

Austria, Belgium, Germany, Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026