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

NCT ID: NCT06572735

Last Updated: 2024-08-27

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-11-01
• Study Completion Date: 2026-05-01

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.

Conditions

Ovarian Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

QoL surveys

Intervention Type: OTHER

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

Geriatric assessment (G-CODE)

Intervention Type: OTHER

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

Blood sampling

Intervention Type: BIOLOGICAL

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.

Interventions

QoL surveys

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

Intervention Type: 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

Intervention Type: OTHER

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.

Intervention Type: BIOLOGICAL

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

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

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

• Minimum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Hospices Civils de Lyon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Claire FALANDRY, Professor

Role: PRINCIPAL_INVESTIGATOR

Hospices Civils de Lyon

Locations

Centre Hospitalier Universitaire d'Amiens Picardie Site Sud

Amiens, , 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

Polyclinique de Blois

La Chaussée-Saint-Victor, , France

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

Lyon, , France

Service de Gériatrie, Hôpital Dr Frédéric Dugoujon

Lyon, , France

Service Oncologie Médicale, Hôpital Lyon Sud

Pierre-Bénite, , France

Institut de Cancérologie et d'Hématologie Universitaire de Saint Etienne

Saint-Priest-en-Jarez, , France

Countries

France

Central Contacts

Claire FALANDRY, Professor

Role: CONTACT

claire.falandry@chu-lyon.fr

04.72.07.18.15 ext. +33

Gabriel ANTHERIEU, MD, PhD

Role: CONTACT

gabriel.antherieu@chu-lyon.fr

04.78.86.15.20 ext. +33

Facility Contacts

Elodie MOREIRA, MD

Role: primary

moreira.elodie@chu-amiens.fr

03.22.45.54.99 ext. +33

Elsa KALBACHER, MD

Role: primary

Elsa.KALBACHER@clermont.unicancer.fr

04.73.27.80.80 ext. +33

Elisabeth CAROLA, MD

Role: primary

Elisabeth.Carola@ghpso.fr

03.44.62.67.65 ext. +33

Leïla BENGRINE LEFEVRE, MD

Role: primary

lbengrine@cgfl.fr

03.80.73.75.06 ext. +33

Yann MOTTAZ, MD

Role: primary

ymottaz@clinique-blois.com

02.54.90.65.58 ext. +33

Amandine BRUYAS, MD

Role: primary

amandine.bruyas@chu-lyon.fr

04.78.86.16.28 ext. +33

Claire FALANDRY, Professor

Role: primary

claire.falandry@chu-lyon.fr

04.72.07.18.15 ext. +33

Nathalie BONNIN, MD

Role: primary

nathalie.bonnin@chu-lyon.fr

04.78.86.43.15 ext. +33

MD

Role: backup

Pauline CORBAUX, MD

Role: primary

pauline.corbaux@chu-st-etienne.fr

04.77.82.29.33 ext. +33

Other Identifiers

69HCL23_0912

Identifier Type: -

Identifier Source: org_study_id