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

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Ovarian Cancer

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Trial Information

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

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.

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

Type of Study:


Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Principal Investigator

Philipp Harter, Dr.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dr. Horst Schmidt Klinik Wiesbaden


Germany: Ethics Commission

Study ID:




Start Date:

September 2006

Completion Date:

October 2009

Related Keywords:

  • Ovarian Cancer
  • ovarian cancer
  • recurrence
  • surgery
  • Ovarian Neoplasms