Study on the Relative Dose Intensity of PARP Inhibitors in Real-life on a Population of Patients Over 70 Years With Advanced Ovarian Cancer

Обзор

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.

Вмешательства

• Другое QoL surveys
  2 quality of life surveys (OV28 and ELD14) will be completed by patients every 3 months during a 12-month period
• Другое Geriatric assessment (G-CODE)
  A geriatric assessment (G-CODE) will be performed by the research staff every 3 months during a 12-month period
• Биопрепарат Blood sampling
  A supplementary volume of blood will be collected from a routine blood sample (8 mL) at 3 different time points : one at inclusion, one 6 and 12 months after the beginning of PARP inhibitors treatment. Genetic lab test will be performed to assess whether there is a specific genetic signature for PARP inhibitors toxicity.

Первичные конечные точки

• Relative dose intensity of the PARP inhibitors treatment [Срок оценки: at 12 months]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Франция · 16 центров

• Centre Hospitalier Universitaire d'Amiens Picardie Site Sud — Amiens
• Clinique de l'Europe — Amiens
• Hôpital Femme-Mère-Enfant — Bron
• Centre de lutte contre le cancer Jean Perrin — Clermont-Ferrand
• Groupe Hospitalier Public Sud de l'Oise — Creil
• Centre Georges François Leclerc — Dijon
• Service Hôpital de jour / Oncologie Médicale, Hôpital de la Croix Rousse — Lyon
• Hôpital Privé Jean Mermoz — Lyon
• … и ещё 8 центров

Идентификаторы

NCT: NCT06572735 · 69HCL23_0912

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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