Ignite Creation Date:
2024-07-17 @ 10:54 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06466382
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-03
First Post:
2024-05-21
Brief Title:
OV Precision Study Examining the Benefit of a Tumor- and Patient-specific Cancer Therapy
Sponsor:
Swiss GO Trial Group
Organization:
Swiss GO Trial Group
Study Overview
Official Title:
OV PRECISION A Randomized Controlled Swiss Trial Examining the Benefit of a Tumor- and Patient-specific Cancer Therapy in Ovarian Cancer
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
OVPrecision
Brief 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
Detailed Description:
Homologous recombination proficient HRP or HRD negative HRDneg Ovarian Cancer OC patients have a poor outcome equivalent to platinum-resistant patients PFS 115 month Given standard of care chemotherapy is not ideal for 50 of EOC and this patient population urgently needs alternative treatment options tailored to their individual tumor profile Treatment options for the heterogeneous HRDneg patient group are scarce and mainly focus on symptom control and palliation delaying time to symptomatic progression and improving QoL
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 ie 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 11 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 092024 final analysis of the focal endpoints and end of the study 10 weeks after inclusion of the last patient 122026 Study analysis and publication should be completed approximately one year later 122027
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 ie 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 11 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 092024 final analysis of the focal endpoints and end of the study 10 weeks after inclusion of the last patient 122026 Study analysis and publication should be completed approximately one year later 122027
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None