A Randomized Multicenter Study to Compare the Efficacy of Additional Tumor Debulking Surgery vs Chemotherapy Alone in Recurrent Platinum-Sensitive Ovarian Cancer
- Patients with first recurrence of platinum sensitive, invasive epithelial ovarian-,
fallopian tube- or primary peritoneal cancer of any initial stage.
- Progression-free interval of at least 6 months after end of last platinum-containing
therapy, or recurrence within 6 months or later after primary surgery if the patient
has not received prior chemotherapy in patients with FIGO I. Non cytostatic
maintenance therapy not containing platinum will not be considered for this
- A positive AGO-score. Obligatory requirements for a positive AGO recurrence score in
1. Performance status ECOG 0
2. No residual tumor after primary surgery (if unknown, alternatively primary FIGO
stage I/II). If report from 1st surgery is not available contact study chairman
who will decide whether inclusion is possible or not.
3. Absence of ascites (cut off < 500 ml: radiological or ultrasound estimation)
- Complete resection of the tumor by median laparotomy seems possible
- Patients who have given their signed and written informed consent and their consent
to data transmission and -processing.
- Patients with non-epithelial tumors as well as borderline tumors.
- Patients without recurrence who are scheduled for diagnostic/second-look surgery or
debulking surgery after completion of chemotherapy
- More than one prior chemotherapy
- Patients with second, third, or later recurrence
- Patients with second malignancies who have been treated by laparotomy, as well as
other neoplasms, if the treatment might interfere with the treatment of relapsed
ovarian cancer or if major impact on prognosis is expected.
- Patients with so-called platinum-refractory tumor, i.e. progression during
chemotherapy or recurrence within 6 months after end of former first
- Only palliative surgery planned
- Radiological signs suggesting metastases not accessible to surgical removal (i.e.
complete resection is deemed impossible)
- Any concomitant disease not allowing surgery and/or chemotherapy
- Any medical history indicating excessive peri-operative risk
- Any current medication inducing considerable surgical risk (e.g. bleeding: due to
oral anticoagulating agents, bevacizumab)