OV Precision: Study Examining the Benefit of a Tumor- and Patient-specific Cancer Therapy
NCT ID: NCT06466382
Last Updated: 2026-01-12
Study Results
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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RECRUITING
NA
60 participants
INTERVENTIONAL
2025-03-31
2028-09-30
Brief Summary
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Detailed Description
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Therefore, trials at initial diagnosis, when the patient can still be cured and is treatment naïve, are urgently needed.
The intervention studied is a personalized treatment recommendation by a specialized molecular tumorboard. This recommendation is based on a molecular summary report (MSR), which is created by multi-modal Tumor Profiling (TP), i.e., molecular analysis of clinical specimens, obtained from the individual participant.
TP, a technology platform of several precision-cancer profiling domains established by the TPC (= Tumor Profiler Center, Switzerland). It combines and rates the most efficient drugs/ experimental treatments for an individual ovarian cancer patient independent of standard of care (SOC).
The usability in clinical practice of this recommendation will be tested. It should support the clinical decision of the treating oncologists and patients to choose the best possible therapy for the individual patient. Treatment recommendations on the most appropriate molecular-based treatment for the individual patient are formulated based on the expertise and experience of the mTB board members. Additionally, a MSR from a validated TP technology platform can serve as further guidance in the tumorboard. However, the final decision on initial treatment remains at the discretion of the treating physician and the patient.
OV Precision is a multicenter randomized (1:1) controlled trial comparing a personalized treatment recommendation at the discretion of the treating physician in agreement with the patient versus SOC without receiving a mTB recommendation.
The study will be divided into two phases: an initial diagnostic phase, in which presumed eligible patients will be recruited into the study, HRD status will be determined, and tumor profiling will be performed in HRDneg patients with a confirmed diagnosis. Eligible patients will be randomized and treated according to their group allocation in the second phase (treatment phase).
The study duration is planned for 3 years including analysis: Two years of recruitment (starting from 09/2024), final analysis of the focal endpoints and end of the study 10 weeks after inclusion of the last patient (12/2026). Study analysis and publication should be completed approximately one year later (12/2027).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Control Arm
Physicians and patients randomized to the SOC arm will not receive the treatment recommendation of the mTB and thus will undergo the standard treatment consisting of 2 cycles of chemotherapy with carboplatin AUC5 3-weekly and paclitaxel 175 mg/m2 3-weekly or carboplatin AUC2 weekly and Paclitaxel 60-80mg/m2 weekly.
Either q3w regime or q1w regime.
Carboplatin / Paclitaxel Chemotherapy
2 cycles of chemotherapy with carboplatin AUC5 3-weekly and paclitaxel 175 mg/m2 3-weekly or carboplatin AUC2 weekly and Paclitaxel 60-80mg/m2 weekly
Interventional Arm
The intervention studied is a treatment recommendation by a specialized molecular tumorboard. This recommendation is based on an MSR which is created by TP, i.e., molecular analysis of clinical specimens, obtained from the individual participant. TP, a technology platform of several precision-cancer profiling domains, combines and rates the most efficient drugs/ experimental treatments for an individual ovarian cancer patient independent of standard of care. The usability in clinical practice of this recommendation will be tested. It should support the clinical decision of the treating oncologists and patients to choose the best possible therapy for the individual patient.
Treatment recommendation by molecular tumorboard (mTB) based on tumor profiling
The intervention studied is a treatment recommendation by a specialized molecular tumorboard (mTB). This recommendation is based on an MSR which is created by TP, i.e., molecular analysis of clinical specimens, obtained from the individual participant. TP, a technology platform of several precision-cancer profiling domains, combines and rates the most efficient drugs/ experimental treatments for an individual ovarian cancer patient independent of standard of care. The usability in clinical practice of this recommendation will be tested. It should support the clinical decision of the treating oncologists and patients to choose the best possible therapy for the individual patient.
Interventions
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Treatment recommendation by molecular tumorboard (mTB) based on tumor profiling
The intervention studied is a treatment recommendation by a specialized molecular tumorboard (mTB). This recommendation is based on an MSR which is created by TP, i.e., molecular analysis of clinical specimens, obtained from the individual participant. TP, a technology platform of several precision-cancer profiling domains, combines and rates the most efficient drugs/ experimental treatments for an individual ovarian cancer patient independent of standard of care. The usability in clinical practice of this recommendation will be tested. It should support the clinical decision of the treating oncologists and patients to choose the best possible therapy for the individual patient.
Carboplatin / Paclitaxel Chemotherapy
2 cycles of chemotherapy with carboplatin AUC5 3-weekly and paclitaxel 175 mg/m2 3-weekly or carboplatin AUC2 weekly and Paclitaxel 60-80mg/m2 weekly
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* No immediate need of systemic or surgical treatment at time of and until 2 weeks after diagnosis
* Envisaged surgical candidate for interval debulking after 2 cycles of treatment
* Willing and able to attend the visits, to understand the purpose of the trial and all trial-related procedures
* ECOG 0-2
* Written informed consent according to national legal and regulatory requirements prior to any project specific procedures
Exclusion Criteria
* Elevated creatinine (double of normal range: \>120 mmol/l))
* ECOG ≥3
* Pregnant or lactating women
* Any other malignancy within the last 5 years which has an impact on the prognosis of the patient
* Inability to swallow tablets
* Concurrent participation in another clinical trial on the same indication
* Any other serious underlying medical, psychiatric, psychological, familial, or geographical condition, which in the judgment of the sponsor-project leader may interfere with the project or affect patient compliance
18 Years
FEMALE
No
Sponsors
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Tumor Profiler Center Switzerland
UNKNOWN
Swiss GO Trial Group
NETWORK
Responsible Party
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Principal Investigators
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Viola Heinzelmann-Schwarz, Prof.
Role: PRINCIPAL_INVESTIGATOR
University Hospital Basel, Head Women's Hospital
Locations
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Kantonsspital Baden AG
Baden, Canton of Aargau, Switzerland
Universitätsspital Basel
Basel, Canton of Basel-City, Switzerland
HOCH Health Ostschweiz Kantonsspital St.Gallen
Sankt Gallen, Canton of St. Gallen, Switzerland
Thurgau AG Frauenfeld / Münsterlingen
Frauenfeld, Thurgau, Switzerland
Inselspital Bern (University Hospital for Medical Oncology)
Bern, , Switzerland
HFR-Fribourg- Hopital Cantonal
Fribourg, , Switzerland
University Hospital Zurich
Zurich, , Switzerland
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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Swiss-GO-08/ OV Precision
Identifier Type: -
Identifier Source: org_study_id
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