Clinical trial NCT06572735: Study on the Relative Dose Intensity of PARP Inhibitors in Real-life on a Population of Patients Over 70 Years With Advanced Ovarian Cancer
Official title: Study on the Relative Dose Intensity of PARP Inhibitors in Real-life on a Population of Patients Over 70 Years With Advanced Ovarian Cancer
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Ovarian Cancer
Keywords: Cancer
ovary
PARP inhibitors
toxicity
elder patients
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2024-08-27
Enrollment: 50
Sex: FEMALE
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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 necessary number of patients in the study is 50.

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Relative dose intensity of the PARP inhibitors treatment
timeFrame: at 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: Centre Hospitalier Universitaire d'Amiens Picardie Site Sud
city: Clermont-Ferrand
country: France
facility: Centre de lutte contre le cancer Jean Perrin
city: Creil
country: France
facility: Groupe Hospitalier Public Sud de l'Oise
city: Dijon
country: France
facility: Centre Georges François Leclerc
city: La Chaussée-Saint-Victor
country: France
facility: Polyclinique de Blois
city: Lyon
country: France
facility: Service Hôpital de jour / Oncologie Médicale, Hôpital de la Croix Rousse
city: Lyon
country: France
facility: Service de Gériatrie, Hôpital Dr Frédéric Dugoujon
city: Pierre-Bénite
country: France
facility: Service Oncologie Médicale, Hôpital Lyon Sud
city: Saint-Priest-en-Jarez
country: France
facility: Institut de Cancérologie et d'Hématologie Universitaire de Saint Etienne
Study officials:
affiliation: Hospices Civils de Lyon
name: Claire FALANDRY, Professor
role: PRINCIPAL_INVESTIGATOR
References: