Ovarian Cancer, Drug Related Neoplasm/Cancer
Conditions
Keywords
recurrent ovarian cancer, PARP inhibitor resistance, secondary cytoreductive surgery, progression during PARP inhibitor maintenance
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.
Detailed description
The primary objective is to find out whether the CRS is beneficial in patients who have progressed on PARPi maintenance.
Interventions
PROCEDUREsecondary cytoreductive surgery
Maximum effort cytoreductive surgery
DRUGchemotherapy
six cycles of platinum-based chemotherapy +/- bevacizumab
Sponsors
Boryung Pharmaceutical Co., Ltd
Chong Kun Dang Pharmaceutical Corp.
Yonsei University
KGOG: Korean Gynaelogical Onology Group, Korea
Japanese Gynecologic Oncology Group
Asia-Pacific Gynecologic Oncology Trials Group (APGOT)
Korea University Guro Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
A randomized superiority trial (Surgery versus No Surgery)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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 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 1. A positive AGO-score or iMODEL+PET/CT 2. 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 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Overall survival | Up to 2 year | from date of randomisation until death |
Other
| Measure | Time frame | Description |
|---|---|---|
| Time to second subsequent anticancer therapy | Up to 2 year | From date of randomization until the date of secondary recurrent anticancer therapy |
| 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 |
| Quality of life | baseline, 6 month and 1year after randomization | EORTC QLQ-C30,OV28, and EQ-5D-5L |
Countries
South Korea
Contacts
Primary ContactHyun-Woong Cho, MD. PhD.
Outcome results
None listed