RecruitingNot ApplicableNCT06466382

OV Precision: Study Examining the Benefit of a Tumor- and Patient-specific Cancer Therapy

OV PRECISION: A Randomized Controlled Swiss Trial Examining the Benefit of a Tumor- and Patient-specific Cancer Therapy in Ovarian Cancer.

Sponsor

Swiss GO Trial Group

Enrollment

60 participants

Start Date

Mar 31, 2025

Study Type

INTERVENTIONAL

Conditions

High-grade Serous Ovarian Carcinoma (HGSOC)Fallopian Tube Neoplasms Ovarian Neoplasm Epithelial Ovarian Endometrioid Carcinoma

Summary

The long-term goal of this research project is to demonstrate whether HRD negative (HPDneg) patients benefit when additional multi-modal biological tumor information is incorporated into the molecular tumor board (mTB) treatment recommendation process.

Eligibility

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria6

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 Criteria8

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

Interventions

OTHERTreatment 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.

DRUGCarboplatin / 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