OV PRECISION: A Randomized Controlled Swiss Trial Examining the Benefit of a Tumor- and Patient-specific Cancer Therapy in Ovarian Cancer.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 10
- 主要终点
- Focal Outcome Measure (FOM) 1 of pilot study: Proportion of patients for whom the molecular Tumor Board (mTB) considers a different treatment option
研究概览
简要总结
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.
详细描述
Homologous recombination proficient (HRP) or HRD negative (HRDneg) Ovarian Cancer (OC) patients have a poor outcome equivalent to platinum-resistant patients (PFS 11.5 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), 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
- •Written informed consent according to national legal and regulatory requirements prior to any project specific procedures
排除标准
- •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))
- •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
研究组 & 干预措施
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.
干预措施: Carboplatin / Paclitaxel Chemotherapy (Drug)
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.
干预措施: Treatment recommendation by molecular tumorboard (mTB) based on tumor profiling (Other)
结局指标
主要结局
Focal Outcome Measure (FOM) 1 of pilot study: Proportion of patients for whom the molecular Tumor Board (mTB) considers a different treatment option
时间窗: 2-3 weeks
* 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)
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.
时间窗: 2-3 weeks
* 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.
FOM 3 of pilot study: Investigation of different treatment decisions by the patient and the treating oncologist.
时间窗: 4 weeks
* 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.
FOM 4 of pilot study: Preliminary estimate of the actual patient benefit of the intervention in terms of a number of patient-relevant outcomes.
时间窗: 10 weeks
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.
次要结局
未报告次要终点