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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

124 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-01

Study Completion Date

2028-12-28

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.

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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.

Conditions

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Ovarian Cancer Drug Related Neoplasm/Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A randomized superiority trial (Surgery versus No Surgery)

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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secondary cytoreductive surgery followed by chemotherapy

surgery arm

Group Type EXPERIMENTAL

secondary cytoreductive surgery

Intervention Type PROCEDURE

Maximum effort cytoreductive surgery

chemotherapy

Intervention Type DRUG

six cycles of platinum-based chemotherapy +/- bevacizumab

chemotherapy

no surgery arm

Group Type ACTIVE_COMPARATOR

chemotherapy

Intervention Type DRUG

six cycles of platinum-based chemotherapy +/- bevacizumab

Interventions

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secondary cytoreductive surgery

Maximum effort cytoreductive surgery

Intervention Type PROCEDURE

chemotherapy

six cycles of platinum-based chemotherapy +/- bevacizumab

Intervention Type DRUG

Other Intervention Names

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secondary cytoreductive surgery followed by chemotherapy no surgery and only chemotherapy

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 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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No