Study on the Relative Dose Intensity of PARP Inhibitors in Real-life on a Population of Patients Over 70 Years With Advanced Ovarian Cancer (PARIB-OLD-PRO²)

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.

Study Overview

• Status: Recruiting
• Conditions: Ovarian Cancer
• Intervention / Treatment: Other: QoL surveys; Other: Geriatric assessment (G-CODE); Biological: Blood sampling

• Study Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

• Study Contact: Name: Claire FALANDRY, Professor; Phone Number: +33 04.72.07.18.15; Email: claire.falandry@chu-lyon.fr
• Study Contact Backup: Name: Gabriel ANTHERIEU, MD, PhD; Phone Number: +33 04.78.86.15.20; Email: gabriel.antherieu@chu-lyon.fr

Study Locations

• France
  • Amiens, France, 80090
    • Recruiting
    • Clinique de l'Europe
    • Contact: Fayçal Dr HOCINE, MD; Phone Number: 0033 3 60 12 53 26; Email: faycal.hocine@cthe-amiens.fr
  • Amiens, France, 80054
    • Recruiting
    • Centre Hospitalier Universitaire d'Amiens Picardie Site Sud
    • Contact: Elodie MOREIRA, MD; Phone Number: +33 03.22.45.54.99; Email: moreira.elodie@chu-amiens.fr
    • Principal Investigator: Elodie MOREIRA, MD
  • Bron, France, 69500
    • Recruiting
    • Hôpital Femme-Mère-Enfant
    • Contact: Marie DR BEGUINOT, MD; Phone Number: 0033 4 72 35 58 85; Email: marie.beguinot-cornillon@chu-lyon.fr
  • Clermont-Ferrand, France, 63011
    • Recruiting
    • Centre de Lutte Contre le Cancer Jean PERRIN
    • Principal Investigator: Elsa KALBACHER, MD
    • Contact: Elsa KALBACHER, MD; Phone Number: +33 04.73.27.80.80; Email: Elsa.KALBACHER@clermont.unicancer.fr
  • Creil, France, 60100
    • Recruiting
    • Groupe Hospitalier Public Sud de l'Oise
    • Principal Investigator: Elisabeth CAROLA, MD
    • Contact: Elisabeth CAROLA, MD; Phone Number: +33 03.44.62.67.65; Email: Elisabeth.Carola@ghpso.fr
  • Dijon, France, 21079
    • Recruiting
    • Centre Georges Francois Leclerc
    • Contact: Leïla BENGRINE LEFEVRE, MD; Phone Number: +33 03.80.73.75.06; Email: lbengrine@cgfl.fr
    • Principal Investigator: Leïla BENGRINE LEFEVRE, MD
  • Lyon, France, 69008
    • Recruiting
    • Hopital Prive Jean Mermoz
    • Contact: Olfa DR DERBEL; Phone Number: 0033 4 37 53 87 25; Email: olfa.derbel@ramsaysante.fr
  • Lyon, France, 69004
    • Recruiting
    • Service Hôpital de jour / Oncologie Médicale, Hôpital de la Croix Rousse
    • Contact: Amandine BRUYAS, MD; Phone Number: +33 04.78.86.16.28; Email: amandine.bruyas@chu-lyon.fr
    • Principal Investigator: Amandine BRUYAS, MD
  • Lyon, France, 69317
    • Recruiting
    • Service de Gériatrie, Hôpital Dr Frédéric Dugoujon
    • Contact: Claire FALANDRY, Professor; Phone Number: +33 04.72.07.18.15; Email: claire.falandry@chu-lyon.fr
    • Principal Investigator: Claire FALANDRY, Professor
  • Paris, France, 75020
    • Recruiting
    • Groupe Hospitalier Diaconesses Croix Saint Simon
    • Contact: Hadiya Dr TARIQ, MD; Phone Number: 0033 6 26 57 80 47; Email: htariq@hopital-dcss.org
  • Pierre-Bénite, France, 69495
    • Recruiting
    • Service Oncologie Médicale, Hôpital Lyon Sud
    • Contact: MD
    • Principal Investigator: Nathalie BONNIN
    • Contact: Nathalie BONNIN, MD; Phone Number: +33 04.78.86.43.15; Email: nathalie.bonnin@chu-lyon.fr
  • Rouen, France, 76100
    • Recruiting
    • Clinique Mathilde
    • Contact: Romain DR KRIKORIAN, MD; Phone Number: 0033 7 87 50 08 44; Email: rkokorian@vivalto-sante.com
  • Saint-Grégoire, France, 35760
    • Recruiting
    • Centre Hospitalier Privé Saint-Grégoire - Les Hôpitaux Privés Rennais
    • Contact: Clément DR PERRET, MD; Phone Number: 0033 2 90 09 44 65; Email: clement.perret@icrb.fr
  • Saint-Priest-en-Jarez, France, 42271
    • Recruiting
    • Institut de Cancérologie et d'Hématologie Universitaire de Saint Etienne
    • Contact: Pauline CORBAUX, MD; Phone Number: +33 04.77.82.29.33; Email: pauline.corbaux@chu-st-etienne.fr
    • Principal Investigator: Pauline CORBAUX, MD
  • Valence, France, 26953
    • Recruiting
    • Centre Hospitalier Valence
    • Contact: Ambroise Dr LAUBY, MD; Phone Number: 0033 4 75 75 75 69; Email: ambroise.lauby@ch-valence.fr
  • Villeurbanne, France, 69100
    • Recruiting
    • Medipole Hopital Mutualiste
    • Contact: Olfa Dr DERBEL, MD; Phone Number: 0033 4 87 65 02 90; Email: o.derbel@resamut.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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.

Other: QoL surveys; 2 quality of life surveys (OV28 and ELD14) will be completed by patients every 3 months during a 12-month period; Other: Geriatric assessment (G-CODE); A geriatric assessment (G-CODE) will be performed by the research staff every 3 months during a 12-month period; Biological: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Relative dose intensity of the PARP inhibitors treatment	Ratio of the delivered PARP inhibitors dose intensity to the planned dose intensity at the beginning of the treatment	at 12 months

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon
• Investigators: Principal Investigator: Claire FALANDRY, Professor, Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start (Actual): September 24, 2024
• Primary Completion (Estimated): January 23, 2028
• Study Completion (Estimated): January 23, 2028

Study Registration Dates

• First Submitted: August 23, 2024
• First Submitted That Met QC Criteria: August 23, 2024
• First Posted (Actual): August 27, 2024

Study Record Updates

• Last Update Posted (Actual): February 23, 2026
• Last Update Submitted That Met QC Criteria: February 20, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Cancer; ovary; toxicity; PARP inhibitors; elder patients
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Endocrine System Diseases; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Genital Diseases, Female; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Neoplasms, Female; Gonadal Disorders; Neoplasms; Ovarian Neoplasms; Health Care Quality, Access, and Evaluation; Investigative Techniques; Epidemiologic Methods; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Data Collection; Health Care Evaluation Mechanisms; Quality of Health Care; Public Health; Environment and Public Health; Population Characteristics; Health Status; Demography; Epidemiologic Measurements; Geriatric Assessment; Blood Specimen Collection
• Other Study ID Numbers: 69HCL23_0912

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No