Abstract
BackgroundApproximately 40% of the newly diagnosed patients with advanced ovarian cancer are aged 70 years or older. Standard treatment for advanced disease consists of cytoreductive surgery and combination chemotherapy. In older patients, standard treatment is often withheld or prematurely stopped due to suspected frailty. It remains challenging to distinguish fit elderly patients who can endure standard therapy from frail patients who may benefit from an adapted treatment strategy. As a comprehensive geriatric assessment (CGA) can contribute to the identification of frail patients and improve tailored therapy in this population, screening tests were developed to select those who may benefit from a CGA. However, the use of these geriatric screening tests has rarely been compared with usual clinical care. The GERSOC-trial will evaluate whether geriatric screening in elderly patients with advanced-stage ovarian cancer improves treatment completion and quality of life.MethodsThis pragmatic, cluster randomised controlled trial will be conducted at a minimum of 20 hospitals in the Netherlands. Hospitals are randomly assigned to geriatric screening care (in which a geriatric screening comprised of the G8 questionnaire and the Timed Up and Go test is performed), or care as usual (in which current usual care is continued). A total of 320 patients aged ≥ 70 years with primary, advanced-stage ovarian carcinoma will be included. Patients considered fit on geriatric screening will receive standard treatment; patients who are considered unfit will be referred to a geriatrician for analysis and treatment advice. The primary outcome is the percentage difference in completed standard and adapted therapies between the two study arms. Secondary outcomes include quality of life, cost-effectiveness and survival.DiscussionThis trial aims to gather evidence for the use of geriatric screening in treatment decision-making in elderly patients with advanced ovarian cancer. If proven feasible, beneficial and cost-effective, geriatric screening may be implemented in routine clinical practice.Trial registrationNetherlands Trial Registry, ID: NL6745. Registered on 2 August 2017.
Highlights
40% of the newly diagnosed patients with advanced ovarian cancer are aged 70 years or older
We aim to investigate whether the introduction of a geriatric screening tool as compared to care as usual improves treatment completion, leading to better quality of life in a cost-effective way in this vulnerable population
As the elderly population is rapidly increasing, the need for tools to distinguish patients who are fit for extensive oncologic treatment from those who will benefit from adapted treatment strategies is emerging
Summary
40% of the newly diagnosed patients with advanced ovarian cancer are aged 70 years or older. The GERSOC-trial will evaluate whether geriatric screening in elderly patients with advanced-stage ovarian cancer improves treatment completion and quality of life. In Europe, 35% of the almost 68,000 patients that were newly diagnosed with ovarian cancer in 2018 were aged 70 years and older [1]. Almost half of the newly diagnosed patients are elderly, this population is underrepresented in randomised clinical trials investigating the optimal treatment of advanced ovarian carcinoma. It is uncertain to which extent the current evidence for ovarian cancer treatment can be extrapolated to the elderly population As a result, it remains unclear which patients can endure the burdensome standard therapy and for whom treatment should be adapted
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