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
1 other identifier
observational
50
1 country
16
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Sep 2024
Typical duration for all trials
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 23, 2024
CompletedFirst Posted
Study publicly available on registry
August 27, 2024
CompletedStudy Start
First participant enrolled
September 24, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 23, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 23, 2028
February 23, 2026
February 1, 2026
3.3 years
August 23, 2024
February 20, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (1)
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.
Interventions
2 quality of life surveys (OV28 and ELD14) will be completed by patients every 3 months during a 12-month period
A geriatric assessment (G-CODE) will be performed by the research staff every 3 months during a 12-month period
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.
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- 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
- Basal cell carcinoma or non-invasive cutaneous squamous cell carcinoma
- Stage 1B or less cervical carcinoma
- Non-invasive superficial bladder cancer
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (16)
Centre Hospitalier Universitaire d'Amiens Picardie Site Sud
Amiens, 80054, France
Clinique de l'Europe
Amiens, 80090, France
Hôpital Femme-Mère-Enfant
Bron, 69500, France
Centre de lutte contre le cancer Jean Perrin
Clermont-Ferrand, 63011, France
Groupe Hospitalier Public Sud de l'Oise
Creil, 60100, France
Centre Georges François Leclerc
Dijon, 21079, France
Service Hôpital de jour / Oncologie Médicale, Hôpital de la Croix Rousse
Lyon, 69004, France
Hôpital Privé Jean Mermoz
Lyon, 69008, France
Service de Gériatrie, Hôpital Dr Frédéric Dugoujon
Lyon, 69317, France
Groupe Hospitalier Diaconesses Croix Saint Simon
Paris, 75020, France
Service Oncologie Médicale, Hôpital Lyon Sud
Pierre-Bénite, 69495, France
Clinique Mathilde
Rouen, 76100, France
Centre Hospitalier Privé Saint-Grégoire - Les Hôpitaux Privés Rennais
Saint-Grégoire, 35760, France
Institut de Cancérologie et d'Hématologie Universitaire de Saint Etienne
Saint-Priest-en-Jarez, 42271, France
Centre Hospitalier Valence
Valence, 26953, France
Médipôle Hôpital Mutualiste
Villeurbanne, 69100, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Claire FALANDRY, Professor
Hospices Civils de Lyon
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 23, 2024
First Posted
August 27, 2024
Study Start
September 24, 2024
Primary Completion (Estimated)
January 23, 2028
Study Completion (Estimated)
January 23, 2028
Last Updated
February 23, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will not share