Personalized cancer therapy for ovarian cancer patients
OV PRECISION: A Randomized Controlled Swiss Trial Examining the Benefit of a Tumor- and Patient-specific Cancer Therapy in Ovarian Cancer.
NA · Swiss GO Trial Group · NCT06466382
This study is testing if personalized treatment plans based on tumor profiles can help newly diagnosed ovarian cancer patients who have limited options feel better and have better outcomes than just standard chemotherapy.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Swiss GO Trial Group (network) |
| Drugs / interventions | chemotherapy |
| Locations | 7 sites (Baden, Canton of Aargau and 6 other locations) |
| Trial ID | NCT06466382 on ClinicalTrials.gov |
What this trial studies
This research focuses on evaluating the benefits of personalized treatment recommendations for patients with homologous recombination proficient (HRP) or HRD negative ovarian cancer. By utilizing multi-modal tumor profiling, the study aims to create a molecular summary report that informs a specialized molecular tumor board in recommending tailored therapies. The goal is to improve treatment outcomes for newly diagnosed patients who are treatment naïve and have limited options beyond standard chemotherapy. The usability of these personalized recommendations in clinical practice will also be assessed.
Who should consider this trial
Good fit: Ideal candidates are newly diagnosed patients with epithelial ovarian cancer, fallopian tube neoplasms, or high-grade serous ovarian carcinoma who are treatment naïve and have a suspected FIGO Stage III or IV.
Not a fit: Patients with elevated liver enzymes, elevated creatinine, or those who are pregnant or lactating may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide more effective and individualized treatment options for patients with HRD negative ovarian cancer.
How similar studies have performed: While personalized treatment approaches are gaining traction, this specific methodology of integrating multi-modal tumor profiling into treatment recommendations is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Newly diagnosed EOC (adenocarcinoma of the ovary, peritoneum, and fallopian tube) and carcinosarcoma patients with a suspected FIGO Stage III and IV * 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 liver enzymes (double of normal range: ASAT \> 68 U/l; ALAT \> 82 U/l; GGT \> 80 U/l) * 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
Where this trial is running
Baden, Canton of Aargau and 6 other locations
- Kantonsspital Baden AG — Baden, Canton of Aargau, Switzerland (RECRUITING)
- Universitätsspital Basel — Basel, Canton of Basel-City, Switzerland (RECRUITING)
- HOCH Health Ostschweiz Kantonsspital St.Gallen — Sankt Gallen, Canton of St. Gallen, Switzerland (RECRUITING)
- Thurgau AG Frauenfeld / Münsterlingen — Frauenfeld, Thurgau, Switzerland (RECRUITING)
- Inselspital Bern (University Hospital for Medical Oncology) — Bern, Switzerland (RECRUITING)
- HFR-Fribourg- Hopital Cantonal — Fribourg, Switzerland (RECRUITING)
- University Hospital Zurich — Zurich, Switzerland (RECRUITING)
Study contacts
- Principal investigator: Viola Heinzelmann-Schwarz, Prof. — University Hospital Basel, Head Women's Hospital
- Study coordinator: Maren S Vogel, PhD
- Email: maren.vogel@usb.ch
- Phone: +41 61 3284203
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Ovarian Neoplasm Epithelial, Fallopian Tube Neoplasms, Ovarian Endometrioid Carcinoma, High-grade Serous Ovarian Carcinoma, Primary ovarian cancer, Treatment naiive, Multi-modal tumor profiling, Treatment recommendation process