Relative dose intensity of PARP inhibitors in people over 70 with advanced ovarian cancer
Study on the Relative Dose Intensity of PARP Inhibitors in Real-life on a Population of Patients Over 70 Years With Advanced Ovarian Cancer
This project will see how often people age 70 and older with advanced ovarian cancer can stay on full PARP inhibitor doses and how blood-related side effects lead to dose changes in routine care.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 70 Years and up |
| Sex | Female |
| Sponsor | Hospices Civils de Lyon Academic / other |
| Locations | 16 sites (Amiens and 15 other locations) |
| Trial ID | NCT06572735 on ClinicalTrials.gov |
What this trial studies
This is a prospective observational study enrolling patients aged 70 or older with FIGO stage III–IV ovarian cancer who are starting maintenance PARP inhibitor therapy for the first time. Participants receive a baseline geriatric assessment (G-CODE), quality-of-life questionnaires, and regular blood tests to monitor hematologic toxicity such as anemia, thrombocytopenia, and neutropenia. Investigators will track dose delays, reductions, discontinuations, and calculate relative dose intensity in real-life practice. The aim is to identify geriatric factors linked to reduced tolerance so clinicians can better tailor monitoring and dosing for older patients.
Who should consider this trial
Good fit: People aged 70 or older with histologically or cytologically confirmed advanced (FIGO III or IV) ovarian cancer who are PARP-inhibitor–naive and about to start maintenance oral PARP therapy, able to take pills and attend follow-up, are ideal candidates.
Not a fit: Patients previously treated with PARP inhibitors, those unable to take oral tablets or attend required visits, or those with a very short expected survival are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the results could help doctors personalize monitoring and dosing so more older patients stay on effective PARP inhibitor treatment with fewer severe blood-related side effects.
How similar studies have performed: PARP inhibitors are proven effective in advanced ovarian cancer generally, but prospective real-life data on dose intensity and tolerability specifically in patients aged 70 and older are limited.
Eligibility criteria
Show full inclusion / exclusion 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 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
Where this trial is running
Amiens and 15 other locations
- Centre Hospitalier Universitaire d'Amiens Picardie Site Sud — Amiens, France (Recruiting)
- Clinique de l'Europe — Amiens, France (Recruiting)
- Hôpital Femme-Mère-Enfant — Bron, France (Recruiting)
- Centre de lutte contre le cancer Jean Perrin — Clermont-Ferrand, France (Recruiting)
- Groupe Hospitalier Public Sud de l'Oise — Creil, France (Recruiting)
- Centre Georges François Leclerc — Dijon, France (Recruiting)
- Service Hôpital de jour / Oncologie Médicale, Hôpital de la Croix Rousse — Lyon, France (Recruiting)
- Hôpital Privé Jean Mermoz — Lyon, France (Recruiting)
- Service de Gériatrie, Hôpital Dr Frédéric Dugoujon — Lyon, France (Recruiting)
- Groupe Hospitalier Diaconesses Croix Saint Simon — Paris, France (Recruiting)
- Service Oncologie Médicale, Hôpital Lyon Sud — Pierre-Bénite, France (Recruiting)
- Clinique Mathilde — Rouen, France (Recruiting)
- Centre Hospitalier Privé Saint-Grégoire - Les Hôpitaux Privés Rennais — Saint-Grégoire, France (Recruiting)
- Institut de Cancérologie et d'Hématologie Universitaire de Saint Etienne — Saint-Priest-en-Jarez, France (Recruiting)
- Centre Hospitalier Valence — Valence, France (Recruiting)
- Médipôle Hôpital Mutualiste — Villeurbanne, France (Recruiting)
Study contacts
- Principal investigator: Claire FALANDRY, Professor — Hospices Civils de Lyon
- Study coordinator: Claire FALANDRY, Professor
- Email: claire.falandry@chu-lyon.fr
- Phone: 04.72.07.18.15
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.