1. AGO-OVAR DESKTOP III (Protocol AGO - OVAR OP.4)
A randomized trial evaluating cytoreductive surgery
in patients with platinum-sensitive recurrent ovarian cancer
Strata:
Platinum-free-interval
6-12 vs > 12 months
1st line platinum
based chx: yes vs no R A N D O M
Cytoreductive
surgery
platinum-based
chemotherapy*
recommended
no surgery
* Recommended platinum-based chemotherapy regimens:
- carboplatin/paclitaxel
carboplatin/gemcitabine
carboplatin/pegliposomal doxorubicin
or other platinum combinations in prospective trials

2. AGO-OVAR DESKTOP III (Protocol AGO - OVAR OP.4)
Primary objective:
- Overall survival
Secondary objectives:
- Progression-free survival
- Quality of Life: EORTC QLQ 30 and NCCN FOSI
- Rate of complete resection as prognostic factor
- Complication rates of surgery
Exploratory analysis of surgical characteristics
and chemotherapy

3. AGO-OVAR DESKTOP III (Protocol AGO - OVAR OP.4)
Inclusion criteria (1):
Patients with 1st recurrence of platinum sensitive, invasive epithelial ovarian-, fallopian tube- or primary peritoneal cancer of any inital stage
Progression-free interval of at least 6 months after end of last platinum based chemotherapy 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 calculation

4. AGO-OVAR DESKTOP III (Protocol AGO - OVAR OP.4)
Inclusion criteria (2):
A positive AGO-score: Obligatory requirements for a positive AGO recurrence score in platinum-sensitive disease:
(1) Performance status ECOG 0
(2) Complete resection at 1st surgery (if unknown FIGO I/II). If report from 1st surgery is not available contact study chairman
(3) Absence of ascites (cut off 500 ml: radiological or ultrasound estimation)
Complete resection of the tumor by median laparotomy seems possible (estimated by an experienced surgeon). Intra-abdominal disease has to be excluded by MRI/CT, if other surgical approaches for extra-abdominal recurrences only are planned
Age > 18 years, signed and written informed consent

5. AGO-OVAR DESKTOP III (Protocol AGO - OVAR OP.4)
Exclusion criteria (1):
Patients with non-epithelial tumors or borderline tumors
Patients without recurrence, but are scheduled for diagnostic/second-look surgery or debulking surgery after completion of chemotherapy
Patients with second, third or later recurrence
Patients with secondary 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

6. AGO-OVAR DESKTOP III (Protocol AGO - OVAR OP.4)
Exclusion criteria (2):
Patients with so-called platinum-refractory tumor, i.e. progression during chemotherapy or recurrence within 6 months atfe end of former first platinum-containing chemotherapy
Only palliative surgery planned
Metastases not accessible to surgical removal
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. anticoagulant agents, bevacizumab)

7. AGO-OVAR DESKTOP III (Protocol AGO - OVAR OP.4)
Datamanagemt and Randomisation: Fax and e-CRF (MACRO)
Central Monitoring
Statistics: HR 0.7 favouring surgery
Sample size: 408 patients/244 events
Recruitment: 36 months
Participating groups from GCIG: AGO, YOU???
Again no full funding - participating groups have to pay local costs