Study on the Relative Dose Intensity of PARP Inhibitors in Real-life on a Population of Patients Over 70 Years With Advanced Ovarian Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 16
- 主要终点
- Relative dose intensity of the PARP inhibitors treatment
研究概览
简要总结
Poly(ADP-ribose) polymerase (PARP) inhibitors are anti-cancer treatments that induce preferential tumor cell death. Their efficacy has been demonstrated in many tumor models, primarily in advanced ovarian cancer. PARP inhibitors also exhibit a particular toxicity, damaging the hematopoietic tissue. With age, pharmacokinetic changes or a reduction in medullary cavity may increase these toxicities and may lead to dose reductions/postponements or premature discontinuation of PARP inhibitors, which may impact the efficacy of treatment. Close biological monitoring must be carried out to limit these toxicities, in most cases anemia, thrombocytopenia and neutropenia. Until now, the geriatric factors impacting the tolerance and uptake of PARP inhibitors in the elderly patient population with advanced ovarian cancer are not clearly established. It is therefore necessary to have prospective real-life data in order to support patients in a decision-making process on whether or not to continue such treatments.
PARIB-OLD-PRO² will evaluate the association between various clinical, biological, and geriatric factors and the relative dose intensity (RDI) of therapy by PARP inhibitors. This is a prospective, multicenter longitudinal and non-interventional study and will involve a population of 50 patients, aged 70 years and elder, with advanced ovarian cancer who are scheduled to start a therapy with PARP inhibitors for the first time. The aim of the study is to better understand the effects of PARP inhibitors on a elderly population, knowledge of the genetic and clinical determinants of PARP inhibitors toxicity in this specific population and an optimal management of this therapy related adverse events in order to maintain an RDI.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 70 Years 至 —（Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 70 years
- •Histologically or cytologically confirmed diagnosis of advanced ovarian cancer (FIGO stage III or IV)
- •PARP inhibitors -naive patient who need to initiate maintenance treatment with PARP inhibitors for the first time (according the the marketing authorization)
- •Patient with a life expectancy of more then 3 months
- •Informed patient which does not oppose to participate to the study
排除标准
- •Prior treatment with PARP inhibitors
- •Patient incapable to take oral tablets/capsules
- •Participation in a drug trial that does not authorize concurrent participation in another trials
- •Person unable to attend scheduled examinations/appointments as part of routine care for geographical, social or psychological reasons
- •Concomitant cancer or f cancer history (other than those included in the inclusion criteria) treated and considered cured for less than 2 years. However, patients with the following pathologies are eligible:
- •Basal cell carcinoma or non-invasive cutaneous squamous cell carcinoma
- •Stage 1B or less cervical carcinoma
- •Non-invasive superficial bladder cancer
研究组 & 干预措施
Patients with advanced ovarian cancer
Patients of 70 years and elder with an advanced ovarian cancer who are scheduled to start a maintenance therapy with PARP inhibitors for the first time. The PARP inhibitors are administrated according to the marketing authorization and will be Olaparib (which may by administrated in combination with Bevacizumab) and Niraparib. There is no specific medical visit for this study, patient are followed in a routine care. Some medical data about the disease follow-up will be collected at inclusion and at each visit, every 3 months over a 12-months period. Furthermore, two quality of life surveys (OV28 and ELD14) and one geriatric assessment will be performed at each visit every 3 months and one 8ml-blood sample will be done at inclusion, and after 6 and 12 months of PARP inhibitors treatment.
干预措施: QoL surveys (Other)
Patients with advanced ovarian cancer
Patients of 70 years and elder with an advanced ovarian cancer who are scheduled to start a maintenance therapy with PARP inhibitors for the first time. The PARP inhibitors are administrated according to the marketing authorization and will be Olaparib (which may by administrated in combination with Bevacizumab) and Niraparib. There is no specific medical visit for this study, patient are followed in a routine care. Some medical data about the disease follow-up will be collected at inclusion and at each visit, every 3 months over a 12-months period. Furthermore, two quality of life surveys (OV28 and ELD14) and one geriatric assessment will be performed at each visit every 3 months and one 8ml-blood sample will be done at inclusion, and after 6 and 12 months of PARP inhibitors treatment.
干预措施: Geriatric assessment (G-CODE) (Other)
Patients with advanced ovarian cancer
Patients of 70 years and elder with an advanced ovarian cancer who are scheduled to start a maintenance therapy with PARP inhibitors for the first time. The PARP inhibitors are administrated according to the marketing authorization and will be Olaparib (which may by administrated in combination with Bevacizumab) and Niraparib. There is no specific medical visit for this study, patient are followed in a routine care. Some medical data about the disease follow-up will be collected at inclusion and at each visit, every 3 months over a 12-months period. Furthermore, two quality of life surveys (OV28 and ELD14) and one geriatric assessment will be performed at each visit every 3 months and one 8ml-blood sample will be done at inclusion, and after 6 and 12 months of PARP inhibitors treatment.
干预措施: Blood sampling (Biological)
结局指标
主要结局
Relative dose intensity of the PARP inhibitors treatment
时间窗: at 12 months
Ratio of the delivered PARP inhibitors dose intensity to the planned dose intensity at the beginning of the treatment
次要结局
未报告次要终点