RecruitingNCT06572735

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


Sponsor

Hospices Civils de Lyon

Enrollment

50 participants

Start Date

Sep 24, 2024

Study Type

OBSERVATIONAL

Conditions

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

Sex: FEMALEMin Age: 70 Years

Inclusion Criteria8

  • 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
  • Basal cell carcinoma or non-invasive cutaneous squamous cell carcinoma
  • Stage 1B or less cervical carcinoma
  • Non-invasive superficial bladder cancer

Exclusion Criteria4

  • 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

Interventions

OTHERQoL surveys

2 quality of life surveys (OV28 and ELD14) will be completed by patients every 3 months during a 12-month period

OTHERGeriatric assessment (G-CODE)

A geriatric assessment (G-CODE) will be performed by the research staff every 3 months during a 12-month period

BIOLOGICALBlood 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.


Locations(16)

Centre Hospitalier Universitaire d'Amiens Picardie Site Sud

Amiens, France

Clinique de l'Europe

Amiens, France

Hôpital Femme-Mère-Enfant

Bron, France

Centre de lutte contre le cancer Jean Perrin

Clermont-Ferrand, France

Groupe Hospitalier Public Sud de l'Oise

Creil, France

Centre Georges François Leclerc

Dijon, France

Service Hôpital de jour / Oncologie Médicale, Hôpital de la Croix Rousse

Lyon, France

Hôpital Privé Jean Mermoz

Lyon, France

Service de Gériatrie, Hôpital Dr Frédéric Dugoujon

Lyon, France

Groupe Hospitalier Diaconesses Croix Saint Simon

Paris, France

Service Oncologie Médicale, Hôpital Lyon Sud

Pierre-Bénite, France

Clinique Mathilde

Rouen, France

Centre Hospitalier Privé Saint-Grégoire - Les Hôpitaux Privés Rennais

Saint-Grégoire, France

Institut de Cancérologie et d'Hématologie Universitaire de Saint Etienne

Saint-Priest-en-Jarez, France

Centre Hospitalier Valence

Valence, France

Médipôle Hôpital Mutualiste

Villeurbanne, France

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NCT06572735


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