Actively Recruiting
The PROOV Study: Exploiting the Synergistic Effect of PARP Inhibition With Cisplatin and Hyperthermia During Interval Cytoreductive Surgery and HIPEC in Ovarian Cancer
Led by The Netherlands Cancer Institute · Updated on 2026-03-10
55
Participants Needed
1
Research Sites
365 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The PROOV study is an open-label, monocenter, single-arm, prospective phase I/II trial with a safety lead-in, evaluating the feasibility of combining PARPi with HIPEC in stage III EOC patients. Phase I is a dose-finding phase with a time-to-event Bayesian Optimal Interval (TITE-BOIN) design, in which three doses of olaparib are evaluated to identify the optimal dose for the phase II part and future trials. The recommended phase II dose (RP2D) will be determined based on the experienced DLTs per dose level and the level of intra-tumor and systemic enzymatic PARP inhibition. During Phase II, the safety profile of the RP2D will be assessed in a total cohort of 40 patients. To provide a proof-of-concept, efficacy will be explored in both translational analyses and survival data.
CONDITIONS
Official Title
The PROOV Study: Exploiting the Synergistic Effect of PARP Inhibition With Cisplatin and Hyperthermia During Interval Cytoreductive Surgery and HIPEC in Ovarian Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed and written informed consent
- At least 18 years of age and able to understand patient information
- Diagnosis of FIGO stage III primary high-grade serous ovarian, fallopian tube, or extra-ovarian cancer
- Resectable stage IV disease allowed if local bowel involvement, abdominal wall metastases, umbilical lesions, or cardiophrenic lymph nodes <1cm
- Diagnosis confirmed by histology or cytology with immunohistochemistry if based on cytology
- Planned for interval cytoreductive surgery with HIPEC after at least 3 courses of carboplatin/paclitaxel chemotherapy
- Response or stable disease after neo-adjuvant chemotherapy with no progression
- Operability confirmed by multidisciplinary team via imaging or laparoscopy with feasible optimal or complete interval cytoreductive surgery
- Fit for major surgery with WHO performance status 0-2
- Adequate bone marrow function (hemoglobin >5.5 mmol/L, leukocytes >3 x10^9/L, platelets >100 x10^9/L)
- Adequate liver function (ALT, AST, bilirubin <2.5 times upper limit of normal)
- Adequate kidney function (creatinine clearance ≥60 ml/min by accepted formulas)
You will not qualify if you...
- History of previous malignancy treated with chemotherapy
- Opting for fertility-sparing surgery
- Concurrent use of potent CYP3A4 inducers or inhibitors that cannot be temporarily stopped
AI-Screening
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Trial Site Locations
Total: 1 location
1
NKI-AvL
Amsterdam, Netherlands, 1066CX
Actively Recruiting
Research Team
M
madelief schreuder-goedheijt
CONTACT
L
leah frenkel
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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