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

Status: Recruiting
Location: See all (16) locations...
Intervention Type: Other, Biological
Study Type: Observational
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
Participation Requirements
Sex: Female
Minimum Age: 70
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
France
Centre Hospitalier Universitaire d'Amiens Picardie Site Sud
RECRUITING
Amiens
Clinique de l'Europe
RECRUITING
Amiens
Hôpital Femme-Mère-Enfant
RECRUITING
Bron
Centre de lutte contre le cancer Jean Perrin
RECRUITING
Clermont-ferrand
Groupe Hospitalier Public Sud de l'Oise
RECRUITING
Creil
Centre Georges François Leclerc
RECRUITING
Dijon
Hôpital Privé Jean Mermoz
RECRUITING
Lyon
Service de Gériatrie, Hôpital Dr Frédéric Dugoujon
RECRUITING
Lyon
Service Hôpital de jour / Oncologie Médicale, Hôpital de la Croix Rousse
RECRUITING
Lyon
Groupe Hospitalier Diaconesses Croix Saint Simon
RECRUITING
Paris
Service Oncologie Médicale, Hôpital Lyon Sud
RECRUITING
Pierre-bénite
Clinique Mathilde
RECRUITING
Rouen
Centre Hospitalier Privé Saint-Grégoire - Les Hôpitaux Privés Rennais
RECRUITING
Saint-grégoire
Institut de Cancérologie et d'Hématologie Universitaire de Saint Etienne
RECRUITING
Saint-priest-en-jarez
Centre Hospitalier Valence
RECRUITING
Valence
Médipôle Hôpital Mutualiste
RECRUITING
Villeurbanne
Contact Information
Primary
Claire FALANDRY, Professor
claire.falandry@chu-lyon.fr
04.72.07.18.15
Backup
Gabriel ANTHERIEU, MD, PhD
gabriel.antherieu@chu-lyon.fr
04.78.86.15.20
Time Frame
Start Date: 2024-09-24
Estimated Completion Date: 2028-01-23
Participants
Target number of participants: 50
Treatments
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.
Sponsors
Leads: Hospices Civils de Lyon

This content was sourced from clinicaltrials.gov