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Trial Title:
Secondary Cytoreductive Surgery (CRS) in Patients With Relapsed Ovarian Cancer Who Have Progressed on PARP Inhibitor Maintenance
NCT ID:
NCT05704621
Condition:
Ovarian Cancer
Drug Related Neoplasm/Cancer
Conditions: Official terms:
Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Neoplasms
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
secondary cytoreductive surgery
Description:
Maximum effort cytoreductive surgery
Arm group label:
secondary cytoreductive surgery followed by chemotherapy
Other name:
secondary cytoreductive surgery followed by chemotherapy
Intervention type:
Drug
Intervention name:
chemotherapy
Description:
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]
Arm group label:
chemotherapy
Arm group label:
secondary cytoreductive surgery followed by chemotherapy
Other name:
no surgery and only chemotherapy
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.
Criteria for eligibility:
Criteria:
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
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 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
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Severance Hospital
Address:
City:
Seoul
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Jung-Yun Lee
Start date:
December 1, 2023
Completion date:
December 28, 2028
Lead sponsor:
Agency:
Korea University Guro Hospital
Agency class:
Other
Collaborator:
Agency:
Boryung Pharmaceutical Co., Ltd
Agency class:
Industry
Collaborator:
Agency:
Chong Kun Dang Pharmaceutical Corp.
Agency class:
Industry
Collaborator:
Agency:
Yonsei University
Agency class:
Other
Source:
Korea University Guro Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05704621
