SOCCER-P: Secondary Cytoreductive Surgery (CRS) in Patients With Relapsed Ovarian Cancer Who Have Progressed on PARP Inhibitor Maintenance
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Detailed Description
The primary objective is to find out whether the CRS is beneficial in patients who have progressed on PARPi maintenance.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: secondary cytoreductive surgery followed by chemotherapy
|
Procedure: secondary cytoreductive surgery
Maximum effort cytoreductive surgery
Drug: chemotherapy
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]
|
| Active Comparator: chemotherapy
|
Drug: chemotherapy
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]
|
Outcome Measures
Primary Outcome Measures
- progression-free survival [Up to 2 year]
interval between date of randomization and the date of second relapse/progression or death, whatever occurs first
Secondary Outcome Measures
- Overall survival [Up to 2 year]
from date of randomisation until death
Other Outcome Measures
- 30-day post-operative complications [From the operation until after 30 days]
MSKCC surgical complications grading method and CTCAE v4.03 criteria will be adopted for evaluating the perioperative complications
- Time to first subsequent anticancer therapy [Up to 1 year]
From date of randomization until the date of first recurrent anticancer therapy
- Time to second subsequent anticancer therapy [Up to 2 year]
From date of randomization until the date of secondary recurrent anticancer therapy
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Patients with first recurrence of platinum sensitive, invasive epithelial ovarian-, fallopian tube- or primary peritoneal cancer of any initial stage.
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Progression-free interval of at least 6 months after end of last platinum- containing therapy,
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Progressed during PARP inhibitor maintenance
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Women aged ≥ 18 years
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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
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A positive AGO-score or iMODEL+PET/CT
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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:
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Patients with non-epithelial tumors as well as borderline tumors.
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Patients without recurrence who are scheduled for diagnostic/second-look surgery or debulking surgery after completion of chemotherapy
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More than one prior chemotherapy
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Patients who are ineligible for pegylated liposomal doxorubicin or carboplatin
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Patients with second, third, or later recurrence
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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.
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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
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Only palliative surgery planned
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Radiological signs suggesting metastases not accessible to surgical removal (i.e. complete resection is deemed impossible)
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Any concomitant disease not allowing surgery and/or chemotherapy
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Any medical history indicating excessive peri-operative risk
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Any current medication inducing considerable surgical risk (e.g. bleeding: due to oral anticoagulating agents, bevacizumab)
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No assessable archival tumor tissue
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Korea University Guro Hospital
- Boryung Pharmaceutical Co., Ltd
- Chong Kun Dang Pharmaceutical Corp.
- Yonsei University
Investigators
- Principal Investigator: Hyun-Woong Cho, MD. PhD., Korea University Guro Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- KGOG