Relative dose intensity of PARP inhibitors in people over 70 with advanced ovarian cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.