OV Precision: Study Examining the Benefit of a Tumor- and Patient-specific Cancer Therapy
NCT Number: NCT06466382
Acronym: OVPrecision
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Ovarian Neoplasm Epithelial|Fallopian Tube Neoplasms|Ovarian Endometrioid Carcinoma|High-grade Serous Ovarian Carcinoma (HGSOC)
Interventions: OTHER: Treatment recommendation by molecular tumorboard (mTB) based on tumor profiling|DRUG: Carboplatin / Paclitaxel Chemotherapy
Sponsor: Swiss GO Trial Group
Collaborators: Tumor Profiler Center Switzerland
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09
Completion Date: 2027-12
Locations: Universitätsspital Basel, Basel, Basel Stadt, 4031, Switzerland

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.

Primary Outcome Measures: Focal Outcome Measure (FOM) 1 of pilot study: Proportion of patients for whom the molecular Tumor Board (mTB) considers a different treatment option, * Number (proportion) of cases in which the Tumor Profiling (TP) was able to generate a conclusive Molecular Summary Report (MSR)
* Number (proportion) of cases in which the mTB considers the MSR as useful support for making a treatment recommendation on a scale from zero (not useful at all) to five (very useful), 2-3 weeks|FOM 2 of pilot study: Investigation whether the treating oncologist feels better supported by the mTB recommendation considers the additional biological tumor information than by the standard of care where such information is not considered., * Number (proportion) of cases in which the treating physician considers the mTB recommendation as useful for making a final treatment decision on a scale from zero (not useful at all) to five (very useful).
* Definition of molecular results from TP that cannot be used for clinical decision making.
* Definition of an algorithm for the decision process from MSR to treatment recommendation., 2-3 weeks|FOM 3 of pilot study: Investigation of different treatment decisions by the patient and the treating oncologist., * Number of therapy adaptations in the exploratory arm based on the MSR.
* Number (proportion) of cases with therapy adaptions with minor / major/ no change from SOC.
* Number (proportion) of treatment recommendations by mTB which were followed by the doctor and patient in the window of opportunity.
* Number (proportion) of treatment recommendations by mTB which were continued by the doctor and patient after the trial and after finishing SOC.
* Number (proportion) of treatment recommendations by mTB which were not followed by the doctor and patient in the window of opportunity due to restrictions.
* Differences in hypothetical treatment costs between SOC and exploratory arm., 4 weeks|FOM 4 of pilot study: Preliminary estimate of the actual patient benefit of the intervention in terms of a number of patient-relevant outcomes., The difference in proportions of responders between the standard of care and experimental arm after interval debulking surgery or biopsy at second specimen collection time point (week 10). A patient is classified as a responder if at least one of the two conditions is met: The Chemotherapy Response Score (CRS) is larger than or equal to 2 or the CA125 KELIM score is larger than or equal to 1.

Note A : The three-tired CRS ranges from 1 (no or minimal tumor response) to 3 (total or near-total tumor response) .

Note B: The tumormarker CA125 level decline (= CA125 KELIM ) over at least 3 timepoints can give an indication of therapy response. A favourable KELIM score ≥ 1.0, Unfavorable KELIM score \< 1.

* Symptoms measured by MOST- S26 questionnaire from V1 (baseline at diagnosis) until V9 (EOT), in both arms.
* Quality of Life (QoL): Questionnaires EORTC QLQ-C30, EORTC QLQ-OV28 from V1 (baseline at diagnosis) until V9 (EOT), in both arms., 10 weeks