Ovarian CancerPARIB-OLD-PRO²NCT06572735
Study on the Relative Dose Intensity of PARP Inhibitors in Real-life on a Population of Patients Over 70 Years With Advanced Ovarian Cancer
An observational study of Ovarian Cancer, run by Hospices Civils de Lyon at 16 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 70 years and older, women only
- Conditions the study is for
- Ovarian Cancer
- What is being tested?
- QoL surveys, Geriatric assessment (G-CODE) and Blood sampling
- How many people
- 50 participants
- Where
- 16 sitesFrance
- Study dates
- 24 Sep 2024to 23 Jan 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- Women only
- No healthy volunteers
- Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
16 sites in 1 country. Contact the study team or a site near you to ask about taking part.
16 sites in 1 country
France16 sites, 16 recruiting
- Recruiting
Centre Hospitalier Universitaire d'Amiens Picardie Site Sud
Amiens, 80054
Elodie MOREIRA, MD, 03.22.45.54.99 ext. +33, moreira.elodie@chu-amiens.fr
Elodie MOREIRA, MD
- Recruiting
Clinique de l'Europe
Amiens, 80090
Fayçal Dr HOCINE, MD, 0033 3 60 12 53 26, faycal.hocine@cthe-amiens.fr
- Recruiting
Hôpital Femme-Mère-Enfant
Bron, 69500
Marie DR BEGUINOT, MD, 0033 4 72 35 58 85, marie.beguinot-cornillon@chu-lyon.fr
- Recruiting
Centre de lutte contre le cancer Jean Perrin
Clermont-Ferrand, 63011
Elsa KALBACHER, MD, 04.73.27.80.80 ext. +33, Elsa.KALBACHER@clermont.unicancer.fr
Elsa KALBACHER, MD
- Recruiting
Groupe Hospitalier Public Sud de l'Oise
Creil, 60100
Elisabeth CAROLA, MD, 03.44.62.67.65 ext. +33, Elisabeth.Carola@ghpso.fr
Elisabeth CAROLA, MD
- Recruiting
Centre Georges François Leclerc
Dijon, 21079
Leïla BENGRINE LEFEVRE, MD, 03.80.73.75.06 ext. +33, lbengrine@cgfl.fr
Leïla BENGRINE LEFEVRE, MD
- Recruiting
Service Hôpital de jour / Oncologie Médicale, Hôpital de la Croix Rousse
Lyon, 69004
Amandine BRUYAS, MD, 04.78.86.16.28 ext. +33, amandine.bruyas@chu-lyon.fr
Amandine BRUYAS, MD
- Recruiting
Hôpital Privé Jean Mermoz
Lyon, 69008
Olfa DR DERBEL, 0033 4 37 53 87 25, olfa.derbel@ramsaysante.fr
- Recruiting
Service de Gériatrie, Hôpital Dr Frédéric Dugoujon
Lyon, 69317
Claire FALANDRY, Professor, 04.72.07.18.15 ext. +33, claire.falandry@chu-lyon.fr
Claire FALANDRY, Professor
- Recruiting
Groupe Hospitalier Diaconesses Croix Saint Simon
Paris, 75020
Hadiya Dr TARIQ, MD, 0033 6 26 57 80 47, htariq@hopital-dcss.org
- Recruiting
Service Oncologie Médicale, Hôpital Lyon Sud
Pierre-Bénite, 69495
Nathalie BONNIN, MD, 04.78.86.43.15 ext. +33, nathalie.bonnin@chu-lyon.fr
MD
- Recruiting
Clinique Mathilde
Rouen, 76100
Romain DR KRIKORIAN, MD, 0033 7 87 50 08 44, rkokorian@vivalto-sante.com
- Recruiting
Centre Hospitalier Privé Saint-Grégoire - Les Hôpitaux Privés Rennais
Saint-Grégoire, 35760
Clément DR PERRET, MD, 0033 2 90 09 44 65, clement.perret@icrb.fr
- Recruiting
Institut de Cancérologie et d'Hématologie Universitaire de Saint Etienne
Saint-Priest-en-Jarez, 42271
Pauline CORBAUX, MD, 04.77.82.29.33 ext. +33, pauline.corbaux@chu-st-etienne.fr
Pauline CORBAUX, MD
- Recruiting
Centre Hospitalier Valence
Valence, 26953
Ambroise Dr LAUBY, MD, 0033 4 75 75 75 69, ambroise.lauby@ch-valence.fr
- Recruiting
Médipôle Hôpital Mutualiste
Villeurbanne, 69100
Olfa Dr DERBEL, MD, 0033 4 87 65 02 90, o.derbel@resamut.fr
About this study
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
- Being tested
- QoL surveys, Geriatric assessment (G-CODE), Blood sampling
- Keywords
- Cancer, ovary, PARP inhibitors, toxicity, elder patients
- Medical subject headings
- Ovarian Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QoL surveysOther
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)Other
A geriatric assessment (G-CODE) will be performed by the research staff every 3 months during a 12-month period
Blood samplingBiological
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: QoL surveys; Other: Geriatric assessment (G-CODE); Biological: Blood sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2024
- Study start24 Sep 2024
- Primary completion23 Jan 2028 (estimated)
- Study completion23 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Claire FALANDRY, Professor, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06572735
- Sponsor's protocol ID
- 69HCL23_0912
- Acronym
- PARIB-OLD-PRO²
- Status last verified
- Feb 2026
- First submitted
- 23 Aug 2024
- Last updated
- 23 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Relative Dose Intensity of PARP Inhibitors in Real-life on a Population of Patients Over 70 Years With Advanced Ovarian Cancer
- ClinicalTrials.gov ID
- NCT06572735
- Acronym / sponsor ID
- PARIB-OLD-PRO² / 69HCL23_0912
- Conditions
- Ovarian Cancer
- Keywords
- Cancer, ovary, PARP inhibitors, toxicity, elder patients
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 24 Sep 2024 (actual)
- Primary completion
- 23 Jan 2028 (estimated)
- Study completion
- 23 Jan 2028 (estimated)
- First posted
- 27 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with advanced ovarian cancer | – | Other: QoL surveys, Other: Geriatric assessment (G-CODE), Biological: Blood samplingPatients 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. |
Who may qualify
- Ages
- 70 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QoL surveys2 quality of life surveys (OV28 and ELD14) will be completed by patients every 3 months during a 12-month period | Other | Patients with advanced ovarian cancer |
| Geriatric assessment (G-CODE)A geriatric assessment (G-CODE) will be performed by the research staff every 3 months during a 12-month period | Other | Patients with advanced ovarian cancer |
| Blood samplingA 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. | Biological | Patients with advanced ovarian cancer |
Primary outcome
Relative dose intensity of the PARP inhibitors treatment
Time frame: at 12 months
Ratio of the delivered PARP inhibitors dose intensity to the planned dose intensity at the beginning of the treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Claire FALANDRY, Professor principal investigator
Hospices Civils de Lyon
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ovarian Cancer, run by Hospices Civils de Lyon at 16 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Claire FALANDRY, Professor (04.72.07.18.15 ext. +33, claire.falandry@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relative dose intensity of the PARP inhibitors treatment (time frame: at 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2026.