Secondary Cytoreductive Surgery (CRS) in Patients With Relapsed Ovarian Cancer Who Have Progressed on PARP Inhibitor Maintenance

Study Overview
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Brief Summary
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This is a randomized phase II study of secondary cytoreductive surgery (CRS) in patients with relapsed ovarian cancer who have progressed on PARP inhibitor maintenance.

Detailed Description
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The primary objective is to find out whether the CRS is beneficial in patients who have progressed on PARPi maintenance.

Official Title
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A Randomized Phase II Study of Secondary Cytoreductive Surgery (CRS) in Patients With Relapsed Ovarian Cancer Who Have Progressed on PARP Inhibitor Maintenance

Conditions
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Drug Related Neoplasm/Cancer, Ovarian Cancer

Intervention / Treatment
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* Procedure: secondary cytoreductive surgery
* Drug: chemotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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, Progressed during PARP inhibitor maintenance Women aged ≥ 18 years 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 isolated extra-abdominal recurrences are planned A positive AGO-score or iMODEL+PET/CT Patients who are likely to be completely resected according to the investigator's judgment will be allowed by consensus between PI(surgeon) and designated radiologist even if AGO or iMODEL+PET/CT negative. Patients who have given their signed and written informed consent and their consent to data transmission and -processing. Exclusion Criteria: 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 who are ineligible for pegylated liposomal doxorubicin or carboplatin 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 platinum- containing therapy 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) No assessable archival tumor tissue

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: secondary cytoreductive surgery followed by chemotherapy<br> | Procedure: secondary cytoreductive surgery<br>* Maximum effort cytoreductive surgery<br>Drug: chemotherapy<br>* six cycles of bevacizumab [10 mg/kg, days 1 and 15] plus carboplatin [AUC 5, day 1] plus pegylated liposomal doxorubicin [30 mg/m2, day 1] every 4 weeks, followed by maintenance bevacizumab [15 mg/kg every 3 weeks]<br>|
| Active Comparator: chemotherapy<br> | Drug: chemotherapy<br>* six cycles of bevacizumab [10 mg/kg, days 1 and 15] plus carboplatin [AUC 5, day 1] plus pegylated liposomal doxorubicin [30 mg/m2, day 1] every 4 weeks, followed by maintenance bevacizumab [15 mg/kg every 3 weeks]<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| progression-free survival | interval between date of randomization and the date of second relapse/progression or death, whatever occurs first | Up to 2 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival | from date of randomisation until death | Up to 2 year |